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.
研究概览
地位
条件
干预/治疗
- 设备：Functional Electrical Stimulation Cycling
- 行为的：Cognitive Task Training
- 设备：Sham Functional Electrical Stimulation Cycling
- 设备：Transcutaneous Auricular Photobiomodulation
- 设备：Transcutaneous Forehead Photobiomodulation
- 设备：Sham Photobiomodulation
- 其他：Optimal FES Cycling Protocol
- 设备：Optimal Neuromodulation Protocol
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Chia-Ling Chen
- 电话号码：8148 +883-3-3281200
- 邮箱：clingchen@gmail.com
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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).
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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. |
|
实验性的：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. |
|
安慰剂比较：Stage 1: Sham FES Cycling
Participants receive sham FES cycling. |
Participants receive the sham FES cycling control condition. |
|
实验性的：Stage 2: Auricular Photobiomodulation
Participants receive transcutaneous auricular photobiomodulation (taPBM). |
Photobiomodulation is applied to the outer ear for approximately 20 to 30 minutes. |
|
实验性的：Stage 2: Forehead Photobiomodulation
Participants receive transcutaneous forehead photobiomodulation (tfPBM). |
Photobiomodulation is applied to the forehead for approximately 20 to 30 minutes. |
|
安慰剂比较：Stage 2: Sham Photobiomodulation
Participants receive sham photobiomodulation. |
Participants receive the sham photobiomodulation control condition. |
|
实验性的：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. |
|
实验性的：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). |
|
实验性的：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). |
|
安慰剂比较：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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Trail Making Test-Part B (TMT-B)
大体时间：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).
|
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Intra-Extra Dimensional Shift (IED)
大体时间：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).
|
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Rapid Visual Information Processing (RVP)
大体时间：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).
|
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Digit Span Test
大体时间：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)
大体时间：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)
大体时间：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).
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Montreal Cognitive Assessment (MoCA)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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).
|
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Grip and Pinch Dynamometry
大体时间：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).
|
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Box and Block Test (BBT)
大体时间：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).
|
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Nine-Hole Peg Test (9HPT)
大体时间：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).
|
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Motor Activity Log (MAL)
大体时间：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
大体时间：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).
|
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Functional Independence Measure (FIM)
大体时间：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).
|
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Stroke Impact Scale (SIS)
大体时间：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).
|
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Stroke-Specific Quality of Life Scale (SS-QOL)
大体时间：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).
|
合作者和调查者
调查人员
- 研究主任：Chia-Ling Chen、Chang Gung Memorial Hospital
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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