Effect of Functional Electrical Stimulation (FES) on Handwriting Rehabilitation After Acquired Brain Injury (ABI)
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:
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：william sit, Ph.D.
- 電話番号：12145627020
- メール：ysit@twu.edu
研究場所
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Texas
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Dallas、Texas、アメリカ、75235-7200
- 募集
- Texas Woman's University
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コンタクト：
- william sit
- 電話番号：2145627020
- メール：ysit@twu.edu
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：順次割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Stroke survivors were recruited from The Stroke Center in Texas.
"be included in the study, participant interest in handwriting remediation."
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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
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Modified COPM, The Print Tool Evaluation & Max300 MoCap Analysis.
時間枠：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
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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 (%) |
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
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IRB-FY2024-420
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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