Effect of Functional Electrical Stimulation (FES) on Handwriting Rehabilitation After Acquired Brain Injury (ABI)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTexas Woman's University
About this trial
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:
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
Functional Electrical Stimulation (FES) on Handwriting Rehabilitation
Combination productThe 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
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: Stroke survivors were recruited from The Stroke Center in Texas.Experimental treatment 1 intervention
Trial outcomes
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 (%)
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 eSponsors and contacts
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Source ClinicalTrials.gov