No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 75
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
36 (estimated)
Sponsor
Texas Woman's University · Other
Who this trial is looking for
This trial is looking for people who have had a stroke or brain injury and have difficulty using their hands. Participants will attend weekly sessions to help improve their handwriting and fine motor skills using electrical stimulation.
Are You a Good Fit for This Trial?
You may be able to join if
I have had a stroke or traumatic brain injury.
My hand function is impaired.
I am at least one month post-injury.
I can attend one-hour sessions weekly for eight weeks.
You may not be able to join if
I have heart disease.
I have a medical device like a pacemaker.
I have venous thrombosis.
I have a history of seizures.
I have impaired sensation in my arms.
I had a stroke or brain injury less than one month ago.
I am pregnant.
I have severe cognitive impairment.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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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Eligibility Criteria
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 …
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.
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