Effect of Functional Electrical Stimulation (FES) on Handwriting Rehabilitation After Acquired Brain Injury (ABI)

NCT07774715 | Recruiting DMC FDA Device

• 1 other identifier: IRB-FY2024-420
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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 (%)

  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

Study Arms (1)

Stroke survivors were recruited from The Stroke Center in Texas.

EXPERIMENTAL

"be included in the study, participant interest in handwriting remediation."

Combination Product: Functional Electrical Stimulation (FES) on Handwriting Rehabilitation

Interventions

Functional Electrical Stimulation (FES) on Handwriting Rehabilitation COMBINATION_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

Stroke survivors were recruited from The Stroke Center in Texas.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Texas Woman's University: lead

Study Sites (1)

Texas Woman's University

Dallas, Texas, 75235-7200, United States

RECRUITING

MeSH Terms

Interventions

proto-oncogene protein c-fes-fps

Central Study Contacts

william sit, Ph.D.

CONTACT

12145627020; ysit@twu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 19, 2026
• Study Start: January 29, 2025
• Primary Completion: August 11, 2026
• Study Completion: August 11, 2026
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)