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| Name | Class |
|---|---|
| Research Grants Council, Hong Kong | OTHER |
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This randomized, double-blind, placebo-controlled trial will investigate whether repetitive transcranial magnetic stimulation (rTMS) applied to the dorsolateral prefrontal cortex (DLPFC) can enhance the effects of dual-task gait training in people with chronic stroke. Participants will be randomly allocated to receive either active rTMS or sham rTMS immediately before the same standardized dual-task gait training program.
The intervention includes 12 sessions over 3 weeks. Outcomes will be assessed at baseline, immediately after training, and at 4-week follow-up. Co-primary outcomes are dual-task mobility and cognitive performance during walking, quantified using dual-task cost (DTC) for gait speed and cognitive-task performance during dual-task walking (e.g., Serial 7s; Shopping List Recall). Secondary outcomes include balance/mobility, community participation, mood/sleep measures, and fall incidence.
To explore mechanisms, prefrontal cortex activity during single- and dual-task walking will be recorded using functional near-infrared spectroscopy (fNIRS), and mediation analyses will examine whether changes in PFC activity explain intervention effects.
Cognitive-motor interference after stroke can reduce walking safety and functional independence, especially during everyday dual-task situations. Dual-task gait training can improve performance, but response varies, potentially due to limitations in executive control and prefrontal network engagement. The DLPFC is central to attention and executive function; therefore, rTMS targeting the DLPFC may prime relevant neural circuits and improve responsiveness to subsequent dual-task training.
This study is a parallel-group, randomized, double-blind, placebo-controlled trial. Community dwelling adults with chronic unilateral stroke will be recruited and randomized 1:1. Participants and outcome assessors will be blinded.
Both groups will complete 12 supervised sessions over 3 weeks. In each session, participants will first receive either: Active rTMS to the DLPFC of the affected hemisphere (5 Hz; 90% resting motor threshold; total 1,200 pulses), or Sham rTMS using the placebo side of the coil with similar auditory sensations.
Dual-task gait training will begin shortly after stimulation. Training will combine functional walking/balance tasks with progressively challenging cognitive tasks (e.g., mental arithmetic, verbal fluency, working memory tasks, and a shopping-list recall task), with difficulty adjusted to participant ability.
Assessments will be conducted at baseline, post-intervention, and 4-week follow-up. Co-primary outcomes are DTC of gait speed and cognitive performance during dual-task walking.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active rTMS with dual-task training | Experimental | Participants will receive rTMS targeting the DLPFC of the affected hemisphere immediately before each session of standardized dual-task gait training (12 sessions over 3 weeks) |
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| sham rTMS with dual-task training | Active Comparator | Participants will receive sham rTMS (placebo stimulation) targeting the same DLPFC location immediately before each session of the same standardized dual-task gait training (12 sessions over 3 weeks). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active rTMS with dual-task training | Other | Participants will receive active rTMS targeting the DLPFC of the affected hemisphere before each training session: 5 Hz, 90% resting motor threshold (RMT), 10-second trains with 30-second inter-train intervals, total 1,200 pulses (≈ 16 minutes) per session. Dual-task gait training will start within ~10 minutes after rTMS. The program includes 12 sessions over 3 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Dual-task cost (DTC) of walking speed (%) | Walking speed (m/s) measured during single-task walking and dual-task walking (walking + Serial 7s; walking + Shopping List Recall). DTC computed as (single-task - dual-task) / single-task × 100%; higher DTC indicates greater cognitive-motor interference. Speed will be averaged across three 45-s trials per condition. | Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8) |
| Dual-task cost (DTC) of cognitive performance (%) | Cognitive performance recorded as number of correct responses during dual-task walking conditions: Serial 7s: number of correct subtractions during the 45-s trial Shopping List Recall: number of items correctly recalled immediately after the 45-s sitting/walking trial. DTC computed as (single-task - dual-task) / single-task × 100%; higher DTC indicates worse cognitive-motor interference. Values averaged across three trials per condition. | Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8) |
| Measure | Description | Time Frame |
|---|---|---|
| Timed Up and Go (TUG) time (seconds) | Time in seconds to complete: (1) standard TUG, and (2) cognitive dual-task TUG with serial 3 subtraction. Lower time indicates better functional mobility. | Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8) |
| Measure | Description | Time Frame |
|---|---|---|
| Prefrontal cortex hemodynamic response (fNIRS HbO) during walking | Changes in bilateral prefrontal cortex oxyhemoglobin (HbO) measured by fNIRS during single- and dual-task walking; used as a mechanistic/mediator outcome. | Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8) |
Inclusion Criteria:
Unilateral ischemic or hemorrhagic hemispheric stroke
Age ≥ 50 years
-≥ 6 months post-stroke
Medically stable
Able to walk independently ≥ 1 minute (assistive device allowed)
Able to follow commands
mRS 1-3
MoCA ≥ 22
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuning LI | Contact | +852 66770121 | shunli.li@connect.polyu.hk | |
| Prof. Marco PANG | Contact | +852 2766 7156 | marco.pang@polyu.edu.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hong Kong Polytechnic University | Recruiting | Hong Kong | HongKong | HKG | Hong Kong |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| sham rTMS with dual-task training | Other | Participants will receive sham rTMS delivered using the placebo side of the same coil at the same DLPFC target location and with identical session duration and procedures (≈ 16 minutes) before each training session. Dual-task gait training will start within ~10 minutes after sham stimulation. The program includes 12 sessions over 3 weeks. |
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| Mini-BESTest total score |
Mini-BESTest total score assessing dynamic balance; higher score indicates better balance control. |
| Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8) |
| Activities-specific Balance Confidence Scale (ABC) score | Self-reported balance confidence (0-100%); higher score indicates greater confidence during daily activities. | Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8) |
| Fall incidence (number of falls) | Number of falls recorded using a fall diary and confirmed during scheduled follow-up contacts. | During 12 months post-intervention follow-up |
| Stride length (cm) | Mean stride length during walking assessed using wearable sensors. | Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8) |
| Reintegration to Normal Living Index (RNLI) score | RNLI score reflecting community participation and reintegration; higher score indicates better reintegration to normal living. | Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8) |
| Cadence (steps/min) | Description: Mean cadence during gait, derived from wearable sensor data. | Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8) |
| Double support time (%) | Percentage of gait cycle spent in double support. | Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8) |
| Gait Speed (m/s) | The rate at which an individual covers distance while walking, typically measured in meters per second. | Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8) |
| Foot Strike Angle (degrees) | The angle of the foot relative to the ground at the moment of initial contact. | Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8) |
| Turns - Duration (seconds) | The time taken to complete a turn while walking. | Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8) |
| Session-level perceived fatigue (0-10 rating) | Self-reported fatigue level rated on a 0-10 numerical scale, assessed immediately before and after each training session. Higher scores indicate greater perceived fatigue. | Before and after each training session (3 weeks) |
| Number of participants with adverse events | Number of participants experiencing adverse events related to tms and dual-task gait training. | During the 3-week intervention period |
| Depression Anxiety Stress Scales-21 (DASS-21) subscale scores |
Depression, Anxiety, and Stress subscale scores from DASS-21; higher scores indicate greater emotional distress. |
| Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8) |
| Pittsburgh Sleep Quality Index (PSQI) global score | PSQI global score assessing sleep quality; higher score indicates poorer sleep quality. | Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8) |
| Fugl-Meyer Assessment-Lower Extremity (FMA-LE) score | FMA-LE motor score (0-34); higher score indicates better lower-limb motor recovery. | Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8) |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |