Effect of Functional Electrical Stimulation (FES) on Handwriting Rehabilitation After Acquired Brain Injury (ABI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Modified COPM, The Print Tool Evaluation & Max300 MoCap Analysis.
研究概览
简要总结
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Stroke survivors were recruited from The Stroke Center in Texas.
"be included in the study, participant interest in handwriting remediation."
干预措施: Functional Electrical Stimulation (FES) on Handwriting Rehabilitation (Combination Product)
结局指标
主要结局
Modified COPM, The Print Tool Evaluation & Max300 MoCap Analysis.
时间窗: 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 (%)
次要结局
未报告次要终点
研究者
William Sit
Professor
Texas Woman's University