Efficacy Study of Functional Electrical Stimulation Controlled by Electromyographic Signal for the Treatment of Upper Limb in Post-stroke Patients "RiSES"

Completed

Phase 2 Results N/A

Trial Description

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.

Conditions

Interventions

Outcomes

Type Measure Time Frame Safety Issue
Primary ARAT (Action Research Arm Test) 5 weeks (post-treatment vs pre-treatment) + 5 weeks (FU)
Primary FMA-UE (Upper Extremities section of Fugl Meyer Assessment scale) 5 weeks (post-treatment vs pre-treatment) + 5 weeks (FU)
Secondary IPPA (Individually Prioritized Problem Assessment) 5 weeks (post-treatment vs pre-treatment)
Secondary DASH (Disability of the Arm Shoulder and Hand questionnaire) + 5 weeks (FU) 5 weeks (post-treatment vs pre-treatment)
Secondary VAS (Visual Analogic Scale for perceived pain) + 5 weeks (FU) 5 weeks (post-treatment vs pre-treatment)

Sponsors