Efficacy Study of FES Controlled by Electromyographic Signal for the Treatment of Upper Limb in Post-stroke Patients

Study Overview
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Brief Summary
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Goal of the present study is to evaluate the efficacy of Myoelectrically-controlled Functional Electrical Stimulation (MeCFES) for the rehabilitation of upper limb in post-stroke patients. MeCFES-assisted rehabilitation will be compared with usual care rehabilitation of upper limb. It is hypothesized that that applying MeCFES in rehabilitation to assist normal arm movements during rehabilitation of the upper limb in persons with stroke will improve the movement quality and success and thus induce recovery at the body functions level (impairment) and the activity level (disability) of the International Classification of Function (ICF) superior to that induced by usual care rehabilitation.

Official Title
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Studio Clinico di Efficacia Della Stimolazione Elettrica Funzionale Controllata da Segnale Elettromiografico Nel Trattamento Dell'Arto Superiore in Pazienti Con Esiti di Ictus Cerebrovascolare (Progetto Rises)

Conditions
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Stroke

Intervention / Treatment
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* Device: MeCFES-assisted task-oriented upper limb rehabilitation
* Other: Usual Care task-oriented upper limb rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hemiplegia/hemiparesis due to a first ischemic or haemorrhagic stroke at least 1 month post-stroke willingness to participate the project minimum voluntary muscle activation of shoulder flexors (>1 Manual Muscle Test) passive Range of Motion (ROM) of the shoulder and elbow of more than 90° Exclusion Criteria: epilepsy severe spasticity at upper limb (>= 3 Ashworth scale) implanted electronic device respiratory insufficiency pregnancy peripheral neuropathies cutaneous ulcers at the stimulation zone other use of FES on the upper limb

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MeCFES<br>25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation | Device: MeCFES-assisted task-oriented upper limb rehabilitation<br> <br> |
| Active Comparator: Control<br>25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation | Other: Usual Care task-oriented upper limb rehabilitation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change Score of ARAT Scale Between Two Time Points: Post-treatment vs Pre-treatment | ARAT: Action Research Arm Test scale (15 item) (see in References section: Van der Lee JH et al 2002). ARAT minimum value is 0 and maximum value is 45. Higher scores mean a better outcome. | 5 weeks (post-treatment vs pre-treatment) | 
| Change Score of FMA-UE Scale Between Two Time Points: Post-treatment vs Pre-treatment | FMA-UE: Upper Extremities section of Fugl Meyer Assessment scale (see in References section: Fugl-Meyer AR et al 1975). FMA-UE minimum value is 0 and maximum value is 66. Higher scores mean a better outcome | 5 weeks (post-treatment vs pre-treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change Score of IPPA Between Two Time Points: Post-treatment vs Pre-treatment | IPPA: Individually Prioritized Problem Assessment (see in References section: Wessels R et al. 2000). IPPA minimum value is 1 and maximum value is 25. Higher scores mean worse outcome. | 5 weeks (post-treatment vs pre-treatment) | 
| Change Score of DASH Between Two Time Points: Post-treatment vs Pre-treatment | DASH: Quick version of the Disability of the Arm Shoulder and Hand questionnaire (see in References section: Kennedy et al. 2011) DASH minimum value is 0 and maximum value is 100. Higher scores mean worse outcome. | 5 weeks (post-treatment vs pre-treatment) | 
| Change Score of VAS for Perceived Pain Between Two Time Points: Post-treatment vs Pre-treatment | VAS: Visual Analogic Scale for perceived pain on a 10-level scale. VAS minimum value is 0 and maximum value is 10. Higher scores mean worse outcome (more severe pain). | 5 weeks (post-treatment vs pre-treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Functional Electrical Stimulation, Cerebrovascular accident, Electromyography