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

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:

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Key information

Conditions

Acquired Brain Injury Including Stroke

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Woman's University

Dallas, Texas, 75235-7200, United States

Location status: Recruiting

Location contact

william sit

CONTACT

[email protected]

2145627020

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

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

Primary outcomes

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

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 (%)

Study contacts

Contact information is provided by the study sponsor or research team.

william sit, Ph.D.

CONTACT

[email protected]

12145627020

Sponsors and collaborators

Lead sponsor

Texas Woman's University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Aug 19, 2026
Registry last updated: Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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