Neuromodulation Combined With Dual FES Cycling and Cognitive Training After Stroke
Exploratory Evaluation of Neuromodulation Combined With Dual Functional Electrical Stimulation Cycling and Cognitive Task Training on Cognitive-Motor Performance in Individuals After Stroke
This study will evaluate the effects of functional electrical stimulation (FES) cycling, cognitive task training, and non-invasive photobiomodulation on cognitive and upper-limb motor performance in adults after stroke. The study includes three stages to identify favorable FES cycling and neuromodulation approaches and to evaluate their combined effects. Participants will complete 10 intervention sessions over 2 weeks. Cognitive and motor outcomes will be assessed before treatment, immediately after treatment, and at 3-month follow-up. Feasibility, tolerance, and adverse events will also be evaluated.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
- デバイス：Functional Electrical Stimulation Cycling
- 行動：Cognitive Task Training
- デバイス：Sham Functional Electrical Stimulation Cycling
- デバイス：Transcutaneous Auricular Photobiomodulation
- デバイス：Transcutaneous Forehead Photobiomodulation
- デバイス：Sham Photobiomodulation
- 他の：Optimal FES Cycling Protocol
- デバイス：Optimal Neuromodulation Protocol
詳細な説明
This is a three-stage, randomized, sham-controlled study in individuals after stroke. Stage 1 will compare FES cycling alone, FES cycling combined with cognitive task training, and sham FES cycling. Stage 2 will compare photobiomodulation applied to the ear, forehead, and sham stimulation. Stage 3 will evaluate the selected FES cycling and neuromodulation approaches alone and in combination. Participants will complete 10 sessions over 2 weeks. Cognitive, upper-extremity motor, functional, participation, and quality-of-life outcomes will be assessed at baseline, immediately after treatment, and at 3-month follow-up. Feasibility, adherence, tolerance, and adverse events will also be monitored.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Chia-Ling Chen
- 電話番号：8148 +883-3-3281200
- メール：clingchen@gmail.com
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Adults aged 20 to 80 years.
- First-ever ischemic or hemorrhagic stroke with unilateral impairment in hand or arm strength or motor function.
- Medically stable and able to participate safely in the training program.
- Able to understand the study procedures and sign the informed consent form.
- Able to follow verbal instructions, comply with study procedures, and complete all assessments.
- Able to maintain a seated position and participate in each training session (approximately 40-60 minutes).
Exclusion Criteria:
- Stroke involving the brainstem or cerebellum.
- History of epilepsy, photosensitive epilepsy, or a tendency to faint.
- Presence of implanted electronic devices, such as pacemakers, implantable cardioverter-defibrillators (ICD), or other electronic medical implants (e.g., artificial heart, infusion pumps, cochlear implants).
- Wounds, infections, or significant skin problems at potential stimulation sites (ear or scalp).
- Presence of major psychiatric disorders or inability to understand or cooperate with testing.
- Cardiovascular or vascular-related conditions, including severe heart disease, uncontrolled arrhythmia, or medical advice against exercise; use of anticoagulant medication that makes laser stimulation inappropriate.
- Acute illness, such as fever or active infection.
- Botulinum toxin injections or relevant surgeries within the past six months.
- Photosensitive disorders (e.g., lupus, porphyria) or current use of photosensitizing medications.
- Inability to safely perform cycling training (e.g., recent fractures, severe spasticity, difficulty maintaining seated posture).
- Pregnant or breastfeeding individuals.
- Any other condition deemed unsuitable by the study physician (e.g., severe claustrophobia).
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：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Stage 1: FES Cycling Alone
Participants receive FES-assisted arm cycling. |
FES-assisted arm cycling is provided for approximately 40 minutes per session, 5 sessions per week for 2 weeks. |
|
実験的：Stage 1: Dual-Task FES Cycling
Participants receive FES-assisted arm cycling combined with cognitive task training. |
FES-assisted arm cycling is provided for approximately 40 minutes per session, 5 sessions per week for 2 weeks. Cognitive tasks are performed during FES cycling and progressively target attention, working memory, and executive control. |
|
プラセボコンパレーター：Stage 1: Sham FES Cycling
Participants receive sham FES cycling. |
Participants receive the sham FES cycling control condition. |
|
実験的：Stage 2: Auricular Photobiomodulation
Participants receive transcutaneous auricular photobiomodulation (taPBM). |
Photobiomodulation is applied to the outer ear for approximately 20 to 30 minutes. |
|
実験的：Stage 2: Forehead Photobiomodulation
Participants receive transcutaneous forehead photobiomodulation (tfPBM). |
Photobiomodulation is applied to the forehead for approximately 20 to 30 minutes. |
|
プラセボコンパレーター：Stage 2: Sham Photobiomodulation
Participants receive sham photobiomodulation. |
Participants receive the sham photobiomodulation control condition. |
|
実験的：Stage 3: Optimal FES Cycling + Sham Neuromodulation
Participants receive the optimal FES cycling protocol identified in Stage 1 combined with sham neuromodulation. |
Participants receive the sham photobiomodulation control condition. The FES cycling condition associated with the most favorable cognitive-motor performance pattern in Stage 1 will be selected for use in Stage 3. The selected protocol will consist of either FES cycling alone or FES cycling combined with cognitive task training. |
|
実験的：Stage 3: Optimal Neuromodulation + Sham FES Cycling
Participants receive the optimal neuromodulation protocol identified in Stage 2 combined with sham FES cycling. |
Participants receive the sham FES cycling control condition. The photobiomodulation condition associated with the most favorable cognitive-motor performance pattern in Stage 2 will be selected for use in Stage 3. The selected protocol will consist of either transcutaneous auricular photobiomodulation (taPBM) or transcutaneous forehead photobiomodulation (tfPBM). |
|
実験的：Stage 3: Optimal FES Cycling + Optimal Neuromodulation
Participants receive the optimal FES cycling protocol combined with the optimal neuromodulation protocol. |
The FES cycling condition associated with the most favorable cognitive-motor performance pattern in Stage 1 will be selected for use in Stage 3. The selected protocol will consist of either FES cycling alone or FES cycling combined with cognitive task training. The photobiomodulation condition associated with the most favorable cognitive-motor performance pattern in Stage 2 will be selected for use in Stage 3. The selected protocol will consist of either transcutaneous auricular photobiomodulation (taPBM) or transcutaneous forehead photobiomodulation (tfPBM). |
|
プラセボコンパレーター：Stage 3: Sham FES Cycling + Sham Neuromodulation
Participants receive sham FES cycling combined with sham neuromodulation. |
Participants receive the sham FES cycling control condition. Participants receive the sham photobiomodulation control condition. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Trail Making Test-Part B (TMT-B)
時間枠：Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
The TMT-B assesses executive function and cognitive flexibility. Longer completion times indicate poorer executive function and cognitive flexibility. |
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
|
Intra-Extra Dimensional Shift (IED)
時間枠：Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
The IED assesses set-shifting ability and cognitive flexibility. Fewer errors indicate better performance. |
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
|
Rapid Visual Information Processing (RVP)
時間枠：Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
The RVP assesses sustained attention. Higher accuracy indicates better sustained attention. |
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
|
Digit Span Test
時間枠：Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
The Digit Span Test assesses working memory and sustained attention. Higher span scores indicate stronger working memory and sustained attention. |
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
|
Fugl-Meyer Assessment-Upper Extremity (FMA-UE)
時間枠：Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
The FMA-UE assesses upper-extremity motor control. Scores range from 0 to 66, with higher scores indicating better motor control. |
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
|
Action Research Arm Test (ARAT)
時間枠：Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
The ARAT assesses upper-limb functional performance. Scores range from 0 to 57, with higher scores indicating better upper-limb function. |
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Montreal Cognitive Assessment (MoCA)
時間枠：Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
The MoCA assesses cognitive functioning across domains including attention, executive function, memory, and visuospatial skills. Scores range from 0 to 30, with higher scores indicating better cognitive functioning. |
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
|
Trail Making Test-Part A (TMT-A)
時間枠：Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
The TMT-A assesses processing speed and attention. Longer completion times indicate poorer processing speed and attention. |
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
|
Symbol Digit Modalities Test (SDMT)
時間枠：Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
The SDMT assesses processing speed. More correct responses indicate better processing speed. |
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
|
Spatial Working Memory (SWM)
時間枠：Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
The SWM assesses working memory. Fewer errors indicate better working memory performance. |
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
|
Paired Associates Learning (PAL)
時間枠：Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
The PAL assesses visual learning. Fewer errors indicate better visual learning performance. |
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
|
Modified Ashworth Scale (MAS)
時間枠：Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
The MAS assesses muscle spasticity. Scores range from 0 to 4, with higher scores indicating greater spasticity. |
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
|
Grip and Pinch Dynamometry
時間枠：Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
Grip and pinch dynamometry measures upper-extremity muscle strength. Higher force output indicates greater muscle strength. |
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
|
Box and Block Test (BBT)
時間枠：Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
The BBT assesses gross manual dexterity. More blocks transferred indicate better gross manual dexterity. |
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
|
Nine-Hole Peg Test (9HPT)
時間枠：Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
The 9HPT assesses fine motor coordination. Shorter completion times indicate better fine motor coordination. |
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
|
Motor Activity Log (MAL)
時間枠：Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
The MAL assesses use of the affected arm in daily activities and perceived quality of movement. Scores range from 0 to 5, with higher ratings indicating greater daily arm use and better movement quality. |
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
|
ABILHAND Questionnaire
時間枠：Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
The ABILHAND Questionnaire assesses perceived manual ability in daily activities. Higher logit scores indicate better perceived manual ability. |
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
|
Functional Independence Measure (FIM)
時間枠：Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
The FIM assesses functional independence. Scores range from 18 to 126, with higher scores indicating greater functional independence. |
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
|
Stroke Impact Scale (SIS)
時間枠：Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
The SIS assesses the impact of stroke on functional recovery. Domain scores range from 0 to 100, with higher scores indicating better functional recovery. |
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
|
Stroke-Specific Quality of Life Scale (SS-QOL)
時間枠：Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
The SS-QOL assesses stroke-specific health-related quality of life. Higher scores indicate better health-related quality of life. |
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
|
協力者と研究者
捜査官
捜査官
- スタディディレクター：Chia-Ling Chen、Chang Gung Memorial Hospital
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
その他の研究ID番号
- 202502050A3
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。