Prepared by: Sophie Warden, Mia Bellafronte, Kevin Mai, Abbi Feltner-Smith Date: 5/1/17 Disclaimer: This CAT was developed in conjunction with an evidence-based practice course. It is not designed to represent a systematic review or definitive expertise on this topic. It is intended to stimulate discussion and our intention is that this critical appraisal may be refuted or revised at any time. While there was peer review it was not blinded and was for the purpose of coursework, not a systematic review.

CLINICAL SCENARIO: Cerebral Vascular Accident (CVA) or commonly referred to as stroke and is considered by the Center of Control and Disease Prevention (CDC) as the fifth leading cause of death in the United States, killing more than 130,000 Americans each year —that is 1 of every 20 deaths. Stroke is a significant cause of disability, resulting in decreased function, independence, and mobility. It is reported that 40% of stroke survivors experience significant functional impairments of the upper limbs (Vafadar, Ct, & Archambault, 2015) and only 50% of stroke survivors are likely to gain back functional use of the upper extremities (Chan, Tong, & Chung, 2009).These severe impairments impact an individual’s functional ability and independence to participate in meaningful occupations such as activities of daily living tasks (ADLs) and instrumental activities of daily living tasks (IADLs).. Occupational therapists often work with individuals who sustained a stroke, helping them identify occupational barriers that may interfere with their ability to engage in meaningful tasks through adaptation, environmental modification, and skill retraining. Interventions for stroke rehabilitation are vast. Clinicians often seek evidence on the effectiveness of different interventions for stroke patients. A number of studies have been conducted to investigate the effectiveness of Functional Electrical Stimulation (FES). FES or FES therapy is defined as “electrical stimulation being used in combination with goal- orientated repetitive movement therapy to augment motor learning in hemiplegia” (Trombly, 2014). The electrical stimulation aims to activate muscles through electrical signals by strategically applying electrodes to the skin to facilitate functional movement in order to reduce level of impairment (Thrasher, Zivanovic, McIlroy, & Popovic, 2008). FOCUSED CLINICAL QUESTION (PICO or PICOT): Does Functional Electrical Stimulation (FES) improve UE mobility in patients in comparison to usual stroke rehabilitation after a CVA?

SUMMARY of Search, ‘Best’ Evidence’ appraised, and Key Findings: Guiding us in our research, we utilized Ageline, CINAHL, Cochrane, OTDBASE, MEDLINE, and other database to find research that investigate the efficacy of using functional electrical stimulation (FES) in improving upper extremity motor function in patients post stroke. During our extensive research, we have identified eight articles that are considered the best evidence to support our focus. Our most compelling research came from a randomized control trial and a pilot study by Thrasher et al. (2008). The review examined participants in the acute and chronic phases of stroke rehabilitation. The acute FES group demonstrated significant improvement in comparison to the chronic group with increased function of the affected upper extremity in term of object manipulation, palmar grip torque, pinch grip pulling force and improved scores in all outcome measures. A randomized control trial study by Chan et al. (2009) investigated the efficacy of FES using bilateral upper extremity retraining. To provide a better understanding of the efficacy of FES treatment, Hill-Hermann (2008) investigated a single subject study using electrical stimulation in conjunction with activity of daily living tasks (ADLs) with a female participant status post 16 months post stroke. The study resulted in decreased impairment in the affected upper extremity, increased fine motor skill, and increased ability to perform ADLs. Ring (2005) study of a randomized design evaluated the efficacy of additional self-treatment program using a neuroprosthesis to improve recovery of post CVA patients with partial hand motion and receiving ongoing sub-acute outpatient rehabilitation. Participants in the FES group demonstrated significant improvement in voluntary movement and functional use of the affected hand. The study suggested benefits with continuation of intervention post standard rehabilitation management.

CLINICAL BOTTOM LINE: Incorporating Functional Electric Stimulation (FES) as a clinical intervention in the treatment of stroke rehabilitation showed significant improvements in outcome measures in hand function and reducing level of disability. Several outcome measures were utilized to support the efficacy of FES therapy which includes the following: Rehabilitation Engineering Laboratory Hand Function Test (i.e. objects, blocks, grip torque, pinch force, eccentric load), Functional Independence Measure, Barthel Index, Fugl-Meyer Assessment, and Chedoke-McMaster Stages of Motor Recovery.

FES therapy has been shown to be effective in recovering upper extremity function in stroke patients. Occupational therapists working in stroke rehabilitation can utilize evidence based practice research on FES to provide alternative interventions to help individuals with stroke regain upper extremity functions.

Limitation of this CAT: This critically appraised paper (or topic) has /has not been peer-reviewed by one other independent person/a lecturer. SEARCH STRATEGY: Terms used to guide Search Strategy · Patient/Client Group: Adults with CVA/stroke · Intervention (or Assessment): Functional Electrical Stimulation (FES) · Comparison: Conventional stroke rehabilitation · Outcome(s): Improved upper extremity mobility and function Audit Trail

Databases and sites searched

Search Terms Limits used

CINAHL Functional electrical stimulation, stroke, occupational therapy,

assistive technologies, upper limb,

2007-2017

MEDLINE functional electrical stimulation, subluxation, stroke

2007-2017

Cochrane Database Functional electrical stimulation & occupational therapy

2007-2017

AgeLine Functional Electrical stimulation, stroke, occupational therapy

2006-2017

Health and Medical Collection

FES, upper extremity, stroke, occupational therapy

Advanced search, full-text, peer reviewed, 2007-2017

INCLUSION and EXCLUSION CRITERIA INCLUSION: Publications written in the last ten years that addressed the effectiveness of Functional Electrical Stimulation (FES) in conjunction with conventional stroke rehabilitation for stroke patients. EXCLUSION: Publications written more than 10 years ago. RESULTS OF SEARCH 8 relevant studies were located and categorised as shown in Table 1 (based on Levels of Evidence, Centre for Evidence Based Medicine, 1998) Table 1: Summary of Study Designs of Articles retrieved

Study Design/ Methodology of Articles Retrieved

Level Number Located

Author (Year)

Single- Subject Study 4 2 Hill-Herman et al. (2008) Bustamante (2016)

Randomized Control Trial 2 4 Chan et al. (2009) Koyuncu et al. (2010) Ring et al. (2005) Thrasher et al.(2008)

Meta-analysis 1 1 Handy et al. (2003)

One-group pre-post study 4 1 Alon (2003)

BEST EVIDENCE The following study of a randomized control trial was identified as the ‘best’ evidence and selected for critical appraisal. Reasons for selecting this study were: ● This study provides the highest level of evidence to address the PICO question ● A researcher was blinded to the intervention and performed all assessments for the study ● Methodology was clarified and consistent ● Outcomes measures were both reliable and valid SUMMARY OF BEST EVIDENCE Table 2: Description and appraisal (Rehabilitation of reaching and grasping function in severe hemiplegic patients using functional electrical stimulation therapy) of a randomized control trial and pivot study by Trasher, Zivanovic, Mcllroy, & Popovic (2008). Aim/Objective of the Study/Systematic Review:

The aim of this study was to establish the efficacy of therapeutic intervention using functional electrical stimulation (FES) versus conventional therapeutic interventions during acute and chronic phases of rehabilitation for individuals post stroke. Study Design: This study consisted of two parts. The first part of the study compared randomized control trial of FES therapy group versus conventional therapy group. The study recruited a sample of the acute hemiplegia population. The second part of the study, FES therapy was applied as a pilot study to a small group of chronic hemiplegia population. All functional improvements and outcome measures were addressed and recorded by a researcher who was blinded to the intervention. Participants recruited in both the control and FES groups received a regimen of conventional therapy including occupational and physiotherapy pertaining to the shoulder, elbow, wrist, and hand function. The control group received therapy 5 days per week for 12 to 16 weeks with each therapy session lasting 45 minutes. Participants in the FES group also received therapy 5 days per week for 12 to 16 weeks, but received a shorter duration of conventional therapy and combined with FES therapy for 45 minutes per session. Participants in the pilot study of the chronic group received FES therapy for 45 minutes for 3 days per week for 12-16 weeks. The chronic group did not receive additional conventional therapy services (i.e. occupational therapy or physiotherapy). All treatment was scheduled for 16 weeks; however several participants were unable to attend the final week of treatment due to issues relating to transportation, family, and so forth. Setting: The study recruited participants from Toronto, Ontario, Canada. The study was implemented at the Toronto Rehabilitation Institute. Participants: Part 1: Acute hemiplegic patients (N=21) recently hospitalized due to a stroke and were admitted to the stroke rehabilitation program at Toronto Rehabilitation Institute were randomly assigned to take part in this study. Eligible participants were required to have a score of 1 to 2 for combined arm and hand on the Chedoke - McMaster Stages of Motor Recovery (CMSMR).The time between onset of the stroke and start of treatment was 2 to 7 weeks. Exclusion criterias included participants with edema, skin rash, allergy, or wound that would interfere with the location of the stimulation electrodes placement. Participants with loss of proprioception were also excluded from this study. Part 2: A convenience sample of chronic hemiplegia population (N=7) was recruited from the Toronto Rehabilitation Institute outpatient facility. The participants had a score of 2 to 3 on CMSMR. All exclusion criterias were applied to both Part 1 and Part 2 studies. Table 2. Subject Demographics and Treatment Times.

Subject Group N Age (Years)

Time Between Stroke and Start

of Treatment

Duration of Treatment (Weeks)

Acute Hemiplegia

Functional Electrical Stimulation

10 57 ± 14.7

29.8 ± 11.8 days

13.5 ± 2.5

Control 11 58 ± 19.7

28.5 ± 9.0 days

13.1 ± 2.4

Chronic Hemiplegia

Chronic 7 56 ± 15.8

2.7 ± 1.8 years 12.9 ± 2.9

(N, diagnosis, eligibility criteria, how recruited, type of sample (eg purposive, random), key demographics such as mean age, gender, duration of illness/disease, and if groups in an RCT were comparable at baseline on key demographic variables; number of dropouts if relevant, number available for follow-up) Intervention Investigated (provide details of methods, who provided treatment, when and where, how many hours of treatment provided) Part 1 | Acute Group: Acute hemiplegia patients in the Part 1 study were randomized into two groups: Control group (N=11) and FES group (N=10) both received conventional occupational therapy and physiotherapy intervention pertaining to shoulder, elbow, wrist, and hand function. Control group: Participants (N=11) received treatment 5 days per week for 12-16 weeks; each therapy session lasted 45 minutes. FES group: Participants (N=10) also received treatment 5 days per week for 12 to 16 weeks, but the duration of the conventional therapy was shorter and combined with FES therapy for 45 minutes per session. Part 2 | Chronic Group: Participants (N=7) received FES therapy for 45 minutes daily 3 days per week for 12 to 16 weeks. The Conventional Training Participants in both the FES therapy group and control group received a regime of conventional therapy services including both occupational therapy and physiotherapy. The conventional intervention include: 1) muscle facilitation exercises emphasizing the neurodevelopmental treatment approach 2) task-specific, repetitive functional training;strengthening and motor control training using resistance to the patient’s volitional movements 3) electrical stimulation applied primarily for isolated muscle strengthening (not for functional training) 4) activities of daily living including self-care where the upper limb was used to assist if appropriate 5) caregiver training FES Therapy Functional electrical stimulation was applied using Compex Motion stimulator, a programmable device designed to provide electrical stimulation sequences for any FES-related application. Treatment was delivered in 2 phases.

Phase 1: Forward reaching motion; nose reaching motion; shoulder adduction followed by elbow extension. Phase 1 was completed by the end of week 6 or 7, when improvement in voluntary shoulder and elbow function was considered sufficient (participants were able to place the affected hand within 50% to 60% of the reach work space). After successful completion of phase 1, the participants were able to volitionally reach forward and were ready to advance forward to grasping training. Phase 2: The second phase consisted of a set of exercises to restore grasping and release function. A neuroprosthesis was applied to the flexors and extensor of the forearm to generate opening and closing patterns of the hand while controlling the wrist angle between the neutral position and a few degrees of extension. The participants were instructed to perform grasp and release patterns using various objects such as a pen, a teacup, and a mobile phone. Components of the task that the participants were unable to perform voluntarily were assisted using FES. When training to grasp and release objects, some or all of the reaching activities described in phase 1 were redone. The purpose of phase 2 was to facilitate increase range of motion of the affected upper extremity during reaching to strengthen the shoulder and elbow muscles, and to inhibit abnormal synergistic movement patterns commonly present in individuals after stroke. In early stages of FES therapy, all of the movements were performed with assistance of FES. In later treatments, the use of FES was reduced to promote particular movement patterns. For example, hand opening or wrist extension, which were identified as the most difficult movement to rehab in this acute population. Movements were performed against gravity with minimal resistance. The number of repetitions were dependent on the participant's’ strength and endurance. In general, a single task would be performed 20 to 30 times per session. Outcome Measures Rehabilitation Engineering Laboratory Hand Function Test Object manipulation test: This test evaluates how a patient used their palmar and lateral (pulp) pinch grasps moving through a pronated, supinated, and in neutral position. To conduct the test, objects are placed in a predetermined order on a surface about 20-30 cm in front of the subject. The subject picks each object up, lifts the object in front of their chest, then moves the object from a pronated to neutral position and then from neutral to supinated position while holding the object in each position for 20-30 seconds. If the subject is unable to hold the object in any of the three positions then no points are given. The subject gets 1 point if he/she is able to hold the object for 2-10 seconds. The subject gets 2 points if he/she is able to hold the object for 20-30 seconds. Non-functional movements are required in respect to this test. The maximum score for both palmar and lateral pinch grasps include: 10 points for pronation, 10 points for neutral position, and 8 points for supination. The minimum score for both grasps in all three positions is 0. Functional Independence Measure (FIM) The Functional Independence Measure (FIM) is a method of disability measurement based on the International Classification of Impairment, Disabilities, and Handicaps (ICF). The test measures the amount of assistance an individual needs to execute various activities of daily living tasks in order to measure their level of disability. The test consists of 18 tasks, 13 motor and 5 cognitive, that are rated on a 7-point ordinal scale, ranging from complete dependence to complete independence. The maximum score an individual can earn is 126, and the lowest score is 18. The assessed tasks include: eating, grooming, bathing,

upper body dressing, lower body dressing, toileting, bladder management, bowel management, bed to chair transfer, toilet transfer, shower transfer, locomotion (ambulatory or wheelchair level), stairs, cognitive comprehension, expression, social interaction, problem solving, and memory. The scoring criteria is as followed:

Score Assistance needed

7 Complete independence

6 Modified independence (No physical assistance required, but patient requires assistive device

5 Supervision or setup

4 Minimal contact assistance (patient performs at least 75% of task)

3 Moderate assistance (patient performs 50-74% of task)

2 Maximal assistance (patient performs 25-49% of task)

1 Total assistance (patient performs less than 25% of task or requires 2 or more people to provide assistance)

Barthel Index The Barthel Index is an assessment that measures the extent to which an individual with a neuromuscular or musculoskeletal disorder is able to independently complete activities of daily living tasks. The assessment measures an individual’s ability to complete the following tasks: Feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair to bed and bed to chair transfers, ambulation/mobility, and stair climbing. The maximum score an individual can receive is 100, and the lowest achievable score is 0. The assessment can be completed with direct observation or reports from family members or caregivers. Chedoke-McMaster Stages of Motor Recovery: The Chedoke-McMaster Stages of Motor Recovery (CMSMR) is an assessment that evaluates the degree of impairment and disability in patients who have experienced stroke or another neurological impairment. The assessment includes two sections, the Impairment Inventory and the Activity Inventory. The Impairment Inventory evaluates whether or not a physical impairment is present and its severity, and the Activity Inventory assesses changes in the patient’s functional abilities. The Impairment Inventory consists of 6 dimensions: stage of shoulder pain, motor recovery, postural control, arm, hand, leg, and foot. Fugl-Meyer Assessment: The Fugl-Meyer Assessment (FMA) is an instrument that assesses and measures the recovery of patients experiencing hemiplegia following a stroke. The measure consists of five domains, totalling 155 items. The five domains are motor functioning in both upper and lower extremities (including movement, coordination, and reflexes of the shoulder, elbow, forearm, wrist, hand, hip, knee, and ankle), sensory functioning (consists of evaluating light touch on two surfaces of the arm and leg and proprioception for 8 joints), balance (3 seated tests and 4 standing tests), range of motion of 8 joints,

and joint pain. Scores are assigned based on direct observation by the clinicians, and scores are given based on the patient’s ability to complete the item. The scale is a 3 point ordinal scale: 0 points indicate the patient is unable to complete the task, 1 point indicates that the patient can partially perform the task, and 2 points indicate that the patient can perform the task fully. The highest possible score on the FMA is 226 and the lowest score is 0. Main Findings:

Acute Population

Chronic Population

Grasping function as measured by the Rehabilitation Engineering Laboratory hand function Test (RELHFT) before and after treatment for chronic hemiplegic subjects (at least 2 year postroke). Trends can be seen, but the results are not statically significant (n=7). Mean value shown with error bars representing 1 standard deviation. Original Authors’ Conclusions:

Thrasher et al. found that hemiplegic patients in acute stroke rehabilitation experienced improved functioning of the hand and reduction in the level of impairment in the upper extremity after a 12-16 week of intensive regimen of Functional Electrical Stimulation (FES). Participants that received the intensive regimen saw better results when compared to subjects that received conventional occupational and physical therapy alone. It was observed that the chronic hemiplegic patients saw trends of improvement; however the statistical power was low due to the small number of patients and the treatment period. Thrasher hypothesized that FES therapy can be effective in chronic hemiplegia, although this cannot be confirmed due the limitations of the pilot study. This study differed from other previous published studies on stroke rehabilitation with focus on reaching and grasping due to it targeted population. Recruited participants for this study had minimal to no movement in the paretic upper extremity. Critical Appraisal: Validity: This study contained both valid and reliable outcome measures to assess the effectiveness of FES. The randomized control trial study was ranked level 2 according to Tomlin Pyramid, which establishes the amount of rigor, and addresses the applicability of the study in practical, clinical settings. Even though all assessments were performed by a researcher who was blinded to the intervention, the study did not indicate who and how the data was collected and interpreted. Interpretation of Results: The acute FES group and the control group experienced improved scores in all outcome measures over the course the 12-16 weeks of treatment. The FES group improved significantly more than the control group in terms of object manipulation, palmar grip torque, and pinch grip pulling force. The acute FES group also improved more than the control group in terms of the BI, FMA, and CMSMR measurements. The results from acute FES group was found to be statistically significant. The chronic group demonstrated improvement in some categories; however, this group was not statistically significant possibly due to the previously mentioned limitations of the study. Summary/Conclusion: Based on the studies, the acute FES group saw improved hand function and minimized upper extremity impairments during the reaching, grasping, and pinching tasks when compared to the participants in the control group who received only conventional occupational and physical therapy. The chronic group saw minimal benefits with FES, however trends of improvements were observed by the researcher. Table x: Characteristics of included studies

Alon, G. et. al,. (2003) - PRETEST - POSTTEST DESIGN

Intervention Investigated: To test if a combined stimulation-training program can improve selected hand functions and impairments of chronic stroke survivors. Comparison Intervention: N/A

Outcome Used: ● Jebsen-Taylor Test battery (light object lift, heavy object lift) ● Jebsen-Taylor Test (simulated feeding) ● Box & Blocks Test ● Nine-Holes Peg Test Finding: Five weeks of daily home training using a hybrid orthosis-stimulation system, with a task-specific stimulation program is likely to improve selected hand functions and upper limb impairments in the majority of patients who have chronic upper extremity paresis.

Bustamante, et. al., (2016)- SINGLE CASE DESIGN

Intervention Investigated: The study investigated if FES can improve proprioception and the scores on measurements of upper limb function and QoL survey. Comparison Intervention: N/A Outcome Used: ● Arm Matching Test (AMT) ● Linear Regression Analysis ● Action Research Arm Test (ARAT) Finding: Results showed FES therapy applied to a chronic stroke patient was associated with favorable outcome in the score of the magnitude of end-position errors in the affected wrist only. The patient showed an improvement of 14 points in the ARAT scores. No changes in joint measurements; however, a significant difference in p-value.28 was observed when comparing the differences between the left and right wrists.

Chan, M. et. al., (2009)- RANDOMIZED CONTROL TRIAL

Intervention Investigated: The study investigated the effectiveness of FES with bilateral activities training in upper limbs function post CVA. Comparison Intervention: FES vs control group receiving a placebo stimulation and bilateral training Outcome Used: ● Functional Test for Hemiplegic Upper Extremity (FTHUE) ● Fugl-Meyer Assessment (FMA) ● Functional Independence Measure ● Modified Ashworth Scale ● Forward Reaching ● Grip Power ● Active Range of Motion Finding: FES combined with bilateral upper limb training could improve motor functions in stroke patients.

Hill-Hermann, et. al., (2008)- SINGLE CASE DESIGN

Intervention Investigated: Examined the efficacy of electrical stimulation in combination with participation with activities of daily living (ADLs). Comparison Intervention: N/A Outcome Used: ● Fugl-Meyer Scale ● The Action Researcher Arm (ARA) ● Arm Motor Activity (AMA)

● The Canadian Occupational Performance Measure (COPM) Finding: One way to facilitate patient-driven, task-specific practice that does not fatigue patients is through functional electrical stimulation. The combination may optimize the brain’s ability to reorganize in a manner most functional to patients.

Ring, H. et. al., (2005)-RANDOMIZED CONTROL TRIAL

Intervention Investigated: This study evaluated the efficacy of self-treatment program using a neuroprosthesis in post - CVA patients. Comparison Intervention: Neuroprosthesis vs. control group Outcome Used: ● Active range of motion ● 7-point scale of thumb opposition ● Modified Ashworth scale ● Blocks and Box test ● Jebsen-Taylor hand tests Finding: Patients receiving the motor, proprioceptive, and cognitive input through the daily use of the neuroprosthesis demonstrated significantly greater improvements in voluntary movement and functional use of the hand.

Thrasher, T. A. et. al., (2008)- RANDOMIZED CONTROL TRIAL/ PILOT STUDY

Intervention Investigated: Implement an FES therapy program in a clinical setting and evaluate it for efficacy during the acute and chronic phases of rehabilitation Comparison Intervention: Part One: Acute - FES vs. conventional intervention. Part Two: Chronic - pre and post assessment of effectiveness of FES Outcome Used: ● Rehabilitation Engineering Laboratory Hand Function Test ● Functional Independence Measure (FIM) ● Barthel Index ● Chedoke-McMaster Stages of Motor Recovery ● Fugl-Meyer Assessment (FMA) Finding: Acute group improved hand function and minimized UE impairments with FES. Benefits of this program for patients with severe chronic hemiplegia were not found in the pilot study.

Handy, et. al., (2003)-META-ANALYSIS

Intervention Investigated: The effectiveness of electrical stimulation on reducing shoulder subluxation, increasing range of motion of the shoulder, decreasing pain and improving function of the upper extremity. Comparison Intervention: None; Meta-analysis focused on studies of electrical stimulation and its effects on upper extremity. Outcome Used: Types of studies examined were “quantifiable trials, including randomized, and quasi-experimental, which included a measurable dependent variable.” (p. 71). Finding: FES can potentially produce a positive effect in patient recovery from stroke-related incidences.

Koyuncu et. al., (2010)- RANDOMIZED CONTROL TRIAL

Intervention Investigated: To investigate the effect of functional electrical stimulation (FES) for the

treatment of shoulder subluxation and shoulder pain in hemiplegic patients. Comparison Intervention: conventional therapy vs conventional therapy and FES Outcome Used: ● VAS Finding: Comparison of the resting AROM vs. PROM VAS value changes showed no significant difference between the groups. There was a significant difference between the two groups for the amount of change in shoulder subluxation in favor of the study group.

IMPLICATIONS FOR PRACTICE & EDUCATION The summation of the research demonstrated that the use of FES in stroke rehabilitation is clinically significant in practice and can be applicable under certain circumstances. When it comes to FES application, occupational therapists need to be knowledgeable about anatomy and kinesiology in order to effectively identify the appropriate muscles recruited for the intervention. They also need to be competent in how to conduct the proper outcome measures during assessments. Unfortunately, FES machines are expensive, which makes it difficult to acquire the necessary equipment to conduct the intervention. However, there are various alternatives available, such as a rental from rehabilitation centers or justifying the needs of FES to third-party payers to acquire equipment for home use. In order for FES to be effective, patients are subjected to an intense and rigorous treatment schedule that can be time consuming, costly, and requires a high degree of commitment from the therapist. The five sessions each week for an hour per session may not be feasible in some clinical settings due to the nature of the intervention and the pathologies of the stroke. Once the patients are discharged home, the expectation to continue the five day a week treatment decreases. Although FES is clinically significant, it benefits can be best applied in outpatient settings. FUTURE RESEARCH OBJECTIVE OF STUDY The aim of this randomized control trial design is to establish the efficacy of functional electrical stimulation (FES) in conjunction with conventional therapeutic interventions during acute phase of rehabilitation for individuals post CVA. METHODOLOGY This study consists of a randomized control trial of (FES) therapy in comparison to conventional therapy for a sample of acute hemiplegia population. Outcome measures are assessed and recorded. PARTICIPANTS Patients with hemiplegia (N=50) who had been recently hospitalized due to a recent stroke are recruited from local stroke rehabilitation hospitals in the community of Portland, Oregon. The acute patients are randomized into 2 groups following all recorded baseline assessment. The first group (N=30) will receive FES therapy and is designated as the “FES group.” The second group (N=20) is designated as the “control group.”. The control group will receive conventional occupational and physical therapy without FES therapy. Randomization will be performed by a computerized system where the participants will be allocated. Participants who are invited to participate in the study have met all of the inclusion and exclusion criterias established for this study.

INCLUSION CRITERIA ● Diagnosis of single stroke in the past 6 months ● Age above 18 year-old ● Level of spasticity in the affected upper extremity less than 4 in the Modified Ashworth Scale ● Able to provide informed consent and >18 years of age ● Able to complete the full duration of the treatment EXCLUSION CRITERIA ● Participants who are pregnant ● Currently participating in any study involving physical rehabilitation ● Pre-existing neurological disease or injury ● Loss of proprioception ● Presence of edema in affected upper extremity, skin rash, allergy or wound at the location where stimulation electrodes would be placed OUTCOME MEASURES All assessment and data collection are performed by a third party researcher who is blinded to the intervention to reduce data contamination. ● Rehabilitation Engineering Laboratory Hand Function Test (RELHFT): assess general function of the affected upper extremity. This test consists of 5 outcome variable relating to the ability to perform following task: 1) manipulation common household objects 2) pick up and release block of varying weight and surface 3) produce axial torque on a cylinder with a palmar grasp 4) measure pinch force on a credit card using lateral grasp while the card is pulled, and 5) hold a cylindrical bar horizontally in a pronated palmar grasp. ● Functional Independence Measure (FIM): assessment of paretic upper extremity motor function by summing the 4 motor components of the FMA test (shoulder/elbow, wrist, hand, and coordination speed) ● Modified Ashworth Scale (MAS): assessment of tone in the paretic upper extremity. ● Fugl-Meyer Assessment (FMA): assessment and measurement of recovery of patients experiencing hemiplegia following a stroke. The measure consists of five domains and a total of 155 items. The five domains are motor functioning in both upper and lower extremities (including movement, coordination, and reflexes of the shoulder, elbow, forearm, wrist, hand, hip, knee, and ankle), sensory functioning (consists of evaluating light touch on two surfaces of the arm and leg and proprioception for 8 joints), balance (3 seated tests and 4 standing tests), range of motion of 8 joints, and joint pain. DESIGN All Participants in both the control and FES groups will receive conventional occupational and physical therapy services focusing on upper extremity mobility retraining (i.e. shoulder, elbow, wrist, and hand function). Both FES and control groups will receive conventional therapy interventions(i.e. Occupational and physical therapy) 5 days per weeks for the span of 24 weeks with each therapy session lasting 60 minutes. Participants in the FES group will receive shorter duration of conventional therapy services in combination with FES therapy for 50 minutes.

CONVENTIONAL THERAPY Conventional therapy will consist of the following interventions: 1) passive/active range of motion and muscle facilitation exercises, 2) task-specific, repetitive functional training, strengthening and motor control training 3) electrical stimulation for isolated muscle strengthening and not for functional training), and 4) activities of daily living tasks including self-care using the affected upper extremity when appropriate. FUNCTIONAL ELECTRICAL STIMULATION THERAPY Functional electrical stimulation therapy is applied to the paretic upper extremity in the FES group using four pair of self-adhesive surface electrodes. Tasks will be performed during stimulations such as reaching forward, moving hand towards mouth and grasping and releasing objects. PROCEDURE FOR FUNCTIONAL ELECTRICAL STIMULATION THERAPY The functional electrical stimulation will be administered to the participants using four pairs of self-adhesive skin electrodes. The electrodes will be place on the major muscle groups that are needed to perform the given task. The therapist performing this intervention with will be trained and certified in electrical stimulation. The device will be programed to distribute stimulation in sequences that elicit a series of muscle contractions that occur during functional movement. The participants will be asked to perform the tasks of reaching forward, moving hand towards mouth and grasping and releasing objects during the 30 minutes of electrical stimulation. The data will be collected by a researcher that was blinded to the assessments and interventions done on each group. The sequence of step during this FES intervention include placing the electrodes on participants skin, setting the device to deliver specific patterns of stimulation, and instructing participants in the tasks they will be performing. At the end of the session, the device will shut down and electrodes will be removed. DATA ANALYSIS To analyze the data we will be using the SSPS 14.0 program. The ANOVA test will be used to compare the outcome measures of the control and experimental group. The means, standard deviation, and statistical significance will be presented. To explore the clinical significance of the intervention, effect size will be calculated using the Cohen d’s. The data will derive from ordinal values therefore a nonparametric statistical test will be selected to test the hypotheses like the Wilcoxon rank- sum test. REFERENCES Handy, J., Salinas, S., Blanchard, S. A., & Aitken, M. J. (2003). Meta-analysis examining the effectiveness of electrical stimulation in improving functional use of the upper limb in stroke patients. Physical And Occupational Therapy In Geriatrics, 21(4), 67-78. Koyuncu, E., Nakipoglu-Yüzer, G., Dogan, A., & Özgirgin, N. (2010). The effectiveness of functional electrical stimulation for the treatment of shoulder subluxation and shoulder pain in hemiplegic patients: a randomized controlled trial. Disability & Rehabilitation, 32(7), 560-566. doi:10.3109/09638280903183811

Thrasher, T. A., Zivanovic, V., McIlroy, W., & Popovic, M. R. (2008). Rehabilitation of reaching and grasping function in severe hemiplegic patients using functional electrical stimulation therapy. Neurorehabilitation & Neural Repair, 22(6), 706-714. Retrieved from: http://search.ebscohost.com.proxy.lib.pacificu.edu:2048/login.aspx?direct=true&db=c8h&AN=105578296&site=ehost-live Trombly, C.A., & Radomski, M.V. (2014). Occupational therapy for physical dysfunction (7thed.). Williams & Wilkins. Chan, M. K., Tong, R. K., & Chung, K. Y. (2009). Bilateral upper limb training with functional electric stimulation in patients with chronic stroke. Neurorehabilitation & Neural Repair, 23(4), 357-365. doi:10.1177/1545968308326428 Hill-Hermann, V., Strasser, A., Albers, B., Schofield, K., Dunning, K., Levine, P., et al. (2008). Task-specific, patient-driven neuroprosthesis training in chronic stroke: Results of a 3-week clinical study. American Journal of Occupational Therapy, 62(4), 466-472. Retrieved from http://search.ebscohost.com.proxy.lib.pacificu.edu:2048/login.aspx?direct=true&db=c8h&AN=105665523&site=ehost-live Ring, H., & Rosenthal, N. (2005). Controlled study of neuroprosthetic functional electrical stimulation in sub-acute post-stroke rehabilitation. Journal of Rehabilitation Medicine (Taylor & Francis Ltd), 37(1), 32-36. Retrieved from http://search.ebscohost.com.proxy.lib.pacificu.edu:2048/login.aspx?direct=true&db=c8h&AN=106631777&site=ehost-live Vafadar, A. K., Côté, J. N., & Archambault, P. S. (2015). Effectiveness of functional electrical stimulation in improving clinical outcomes in the upper arm following stroke: A systematic review and meta-analysis. BioMed Research International, 2015, 1-14. doi:10.1155/2015/729768 Koyuncu, E., Nakipoglu-Yüzer, G., Dogan, A., & Özgirgin, N. (2010). The effectiveness of functional electrical stimulation for the treatment of shoulder subluxation and shoulder pain in hemiplegic patients: a randomized controlled trial. Disability & Rehabilitation, 32(7), 560-566. doi:10.3109/09638280903183811 Alon, G., et. al. (2003). A home-based, self administered stimulation program to improve selected hand functions of chronic stroke. Neurorehabilitation, 18(3), pp. 215-225 Popovic, M. B., Popovic, D. B., Schwirtlich, L., & Sinkjær, T. (2004). Functional electrical therapy (FET): Clinical trial in chronic hemiplegic subjects. Neuromodulation, 7(2), 133-140. doi:10.1111/j.1094-7159.2004.04017.x Bustamante, C., Brevis, F., Canales, S., Millón, S., & Pascual, R. (2016). Effect of functional electrical stimulation on the proprioception, motor function of the paretic upper limb, and patient quality of life: A case report. Journal of Hand Therapy, 29(4), 507-514. doi:http://dx.doi.org.proxy.lib.pacificu.edu:2048/10.1016/j.jht.2016.06.012 Thorsen, R., Cortesi, M., Jonsdottir, J., Carpinella, I., Morelli, D., Casiraghi, A., ...Ferrarin, M. (2013). Myoelectrically driven functional electrical stimulation may increase motor recovery of upper limb in poststroke subjects: a randomized controlled pilot study. Journal of Rehabilitation Research & Development, 50(6), 785+. Retrieved from

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