Pilot Study Evaluating the FitFES Electromyographic-Controlled Device for Upper Limb Rehabilitation in Adults After Stroke

What this Trial Is About

Researchers are evaluating a wearable device called FitFES designed to support upper limb motor rehabilitation in adults who have had a stroke. Upper limb disabilities are common and challenging after stroke, and this study aims to compare the effects of using FitFES with traditional rehabilitation therapy. The device works by stimulating muscles based on the patients residual muscle activity to help improve coordination and strength during voluntary movements. Participants will be randomly assigned to one of two groups an experimental group using the FitFES device during task-oriented exercises, or a control group performing the same exercises without the device. Both groups will complete 15 individual rehabilitation sessions, each lasting 60 minutes, conducted three to five times per week over three to five weeks depending on session frequency. Before and after the rehabilitation program, and again one month later, participants will be assessed using various tests including the Action Research Arm Test, Fugl-Meyer Upper Extremity scale, Box and Block test, and quality of life questionnaires. Additional measures like muscle activity and body movement will be recorded to evaluate changes. Safety and cost-effectiveness of the treatment will also be monitored throughout the study.

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