Acquired Brain Injury Including StrokeNCT07774715
Effect of Functional Electrical Stimulation (FES) on Handwriting Rehabilitation After Acquired Brain Injury (ABI)
A study testing Functional Electrical Stimulation (FES) on Handwriting Rehabilitation in people with Acquired Brain Injury Including Stroke, run by Texas Woman's University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acquired Brain Injury Including Stroke
- What is being tested?
- Functional Electrical Stimulation (FES) on Handwriting Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2025to 11 Aug 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have experienced either an ischemic or hemorrhagic stroke or a traumatic brain injury (TBI), resulting in impaired hand function.
- Participants should have completed the acute phase of recovery, have had an onset of injury more than one month ago, and be in the subacute or chronic phase (at least one month after the injury).
- Participants must demonstrate motor impairments affecting fine motor control and handwriting ability.
- Participants should be able to attend one-hour weekly sessions for eight weeks.
Who cannot join
- Cardiac disease to avoid potential interference with heart function during FES
- Presence of an implanted medical stimulator (e.g., pacemaker) to prevent device interference and ensure participant safety.
- Venous thrombosis or thrombophlebitis to reduce the risk of exacerbating these conditions with electrical stimulation.
- History of seizure disorder to avoid triggering seizures with electrical stimulation.
- Impaired sensation in the upper extremities to ensure accurate feedback regarding comfort and prevent unnoticed overstimulation.
- Medically stable with a stroke or traumatic brain injury less than one month ago - to focus on individuals in the subacute or chronic recovery phase.
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- Participants who are pregnant - to minimize any potential risk to the participant or fetus.
- Individuals with bilateral upper extremity coordination to focus on individuals with unilateral impairments for this study
- Participants with severe cognitive impairment or communication barriers to ensure participants can understand instructions, provide feedback, and give informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Texas Woman's University
Dallas, Texas, 75235-7200
william sit, 2145627020, ysit@twu.edu
About this study
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:
- Conditions
- Acquired Brain Injury Including Stroke
- Being tested
- Functional Electrical Stimulation (FES) on Handwriting Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Electrical Stimulation (FES) on Handwriting RehabilitationCombination product
The 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 group | Role | What they receive |
|---|---|---|
| Stroke survivors were recruited from The Stroke Center in Texas. | Experimental | "be included in the study, participant interest in handwriting remediation." Receives: Combination Product: Functional Electrical Stimulation (FES) on Handwriting Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified COPM, The Print Tool Evaluation & Max300 MoCap Analysis.
Modified COPM assessment includes:
Scale (1-10), 1= not important at all 10= very important for satisfaction and performance.
The outcome measures of the Print Tool are:
A quantitative score (Scale, 0-61) was generated based on 7 handwriting performance factors, including memory, orientation, placement, size, start, sequence, and control.
The MoCap assessments include:
displacement (m), movement time (s), peak velocity (m/s), percentage of movement time to peak velocity (%)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start29 Jan 2025
- Primary completion11 Aug 2026
- Study completion11 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain Injury Including StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Sit, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774715
- Sponsor's protocol ID
- IRB-FY2024-420
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No