Effect of Functional Electrical Stimulation (FES) on Handwriting Rehabilitation After Acquired Brain Injury (ABI)
Part of paid clinical trials in Dallas, Texas.
- Sponsor
- Texas Woman's University
- Study ID
- NCT07774715
- Status
- Recruiting
Conditions
- Acquired Brain Injury Including Stroke
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Functional Electrical Stimulation (FES) on Handwriting Rehabilitation — COMBINATION_PRODUCTThe principal investigator (PI) and co-principal investigator (co-PI) will screen participants based on the inclusion and exclusion criteria with a screening form. If participants are eligible, informed consent will be obtained before the study begins. The co-PI will generate non-identifiable codes for each participant using an Excel spreadsheet to maintain confidentiality throughout the research study. Participants will be randomly assigned to one of two groups using a computer-generated randomization process in Excel, ensuring unbiased group allocation. Participants will not be aware of their group assignment until after randomization. If participants decline their assigned intervention, they can withdraw from the study, as participation is voluntary. The control group will receive an OT handwriting program with functional-based activities without functional electrical stimulation (FES). In contrast, the treatment group will use the same OT handwriting program with functional-based a
Study Details
Study Purpose Functional Electrical Stimulation (FES) enhances motor recovery by increasing the functional range of motion to significantly improve muscle force deficits following an acquired brain injury. While FES has shown promise in improving muscular activation, its role in facilitating fine motor skills like handwriting in the acquired brain injury population needs further investigation. The project will incorporate motion capture (mo-cap) analysis technology, which will capture participants' detailed movement patterns during handwriting tasks and provide multi-baseline pre-analysis/post-analysis of motor planning and execution for precise tracking of manual dexterity improvements by quantifying changes in fine motor control, speed, and accuracy. The study seeks to provide comprehensive evidence of FES's effectiveness in hand remediation with combined assistive technology with functional-based activity to enhance motor function and improve acquired brain injury survivors' quality of life by enabling better outcomes in daily tasks requiring fine motor skills. Functional electrical stimulation improves reaching movement in the shoulder and elbow muscles of stroke patients:
Key Dates
- First listed
- Aug 19, 2026
- Start date
- Jan 29, 2025
- Status verified
- Aug 2026
- Primary completion
- Aug 11, 2026
- Completion
- Aug 11, 2026
Study Design
- Enrollment
- 36 participants (estimated)
- Allocation
- NA
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Stroke survivors were recruited from The Stroke Center in Texas."be included in the study, participant interest in handwriting remediation."
Primary Outcome Measure
Modified COPM, The Print Tool Evaluation & Max300 MoCap Analysis. [ Time Frame: The study protocol will take 10 weeks to complete. Participants will attend: 8 weekly sessions per week (1 hour each) over 8 weeks. Two baseline sessions during Week 1 (1 hour each) include DASH-1, modified COPM, and 30 minutes of MoCap analysis during e ]
Central Contacts
- william sit, Ph.D.12145627020
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Texas Woman's University | Dallas | Texas | 75235-7200 |