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Purpose

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:

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Stroke survivors were recruited from The Stroke Center in Texas. 		"be included in the study, participant interest in handwriting remediation."
  • Combination Product: Functional Electrical Stimulation (FES) on Handwriting Rehabilitation
    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

Recruiting Locations

Texas Woman's University
Dallas, Texas 75235-7200
Contact:
william sit
2145627020
ysit@twu.edu

More Details

Status
Recruiting
Sponsor
Texas Woman's University

Study Contact

william sit, Ph.D.
12145627020
ysit@twu.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.