Handwriting rehabilitation after brain injury using Functional Electrical Stimulation (FES)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial uses Functional Electrical Stimulation to target hand movements in people who have impaired fine motor control after an acquired brain injury, including stroke or TBI. Participants will undergo an eight-week program with one-hour weekly sessions, guided by motion capture analysis to track changes in dexterity, speed, and accuracy. The study aims to provide objective evidence on whether FES can enhance handwriting abilities when combined with functional tasks and assistive technology. Safety considerations exclude individuals with certain conditions or implanted devices to protect participant well-being. The research is conducted at Texas Woman's University in Dallas, with the sponsor overseeing coordination.

Why it matters

Who can join: the full rules

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.

Where it's running

• Texas Woman's University
  Dallas, Texas, United States Recruiting

Study contacts

• Study coordinator: william sit, Ph.D.
• Email: ysit@twu.edu
• Phone: 12145627020

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.