Stroke
Conditions
Keywords
Dual-task training, rTMS, Post-stroke rehabilitation, Cognitive-motor interference
Brief summary
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.
Detailed description
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.
Interventions
OTHERactive rTMS with dual-task training
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.
OTHERsham rTMS with dual-task training
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.
Sponsors
The Hong Kong Polytechnic University
Research Grants Council, Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
* Other neurological disorders * Cerebellar/brainstem injury * TMS contraindications (e.g., pacemaker, intracranial metal, seizure history, pregnancy) * Contraindications to exercise (e.g., unstable angina) * Severe aphasia (NIHSS item 9 ≥ 2) * Pain/illness limiting performance * Concurrent formal rehabilitation elsewhere * RMT cannot be determined * Fails TMS safety screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dual-task cost (DTC) of walking speed (%) | Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8) | 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. |
| Dual-task cost (DTC) of cognitive performance (%) | Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timed Up and Go (TUG) time (seconds) | Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8) | Time in seconds to complete: (1) standard TUG, and (2) cognitive dual-task TUG with serial 3 subtraction. Lower time indicates better functional mobility. |
| Mini-BESTest total score | Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8) | Mini-BESTest total score assessing dynamic balance; higher score indicates better balance control. |
| Activities-specific Balance Confidence Scale (ABC) score | Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8) | Self-reported balance confidence (0-100%); higher score indicates greater confidence during daily activities. |
| Fall incidence (number of falls) | During 12 months post-intervention follow-up | Number of falls recorded using a fall diary and confirmed during scheduled follow-up contacts. |
| Stride length (cm) | Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8) | Mean stride length during walking assessed using wearable sensors. |
| Reintegration to Normal Living Index (RNLI) score | Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8) | RNLI score reflecting community participation and reintegration; higher score indicates better reintegration to normal living. |
| Cadence (steps/min) | Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8) | Description: Mean cadence during gait, derived from wearable sensor data. |
| Double support time (%) | Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8) | Percentage of gait cycle spent in double support. |
| Gait Speed (m/s) | Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8) | The rate at which an individual covers distance while walking, typically measured in meters per second. |
| Foot Strike Angle (degrees) | Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8) | The angle of the foot relative to the ground at the moment of initial contact. |
| Turns - Duration (seconds) | Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8) | The time taken to complete a turn while walking. |
| Session-level perceived fatigue (0-10 rating) | Before and after each training session (3 weeks) | 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. |
| Number of participants with adverse events | During the 3-week intervention period | Number of participants experiencing adverse events related to tms and dual-task gait training. |
Countries
Hong Kong
Contacts
CONTACTShuning LI
CONTACTProf. Marco PANG
Outcome results
None listed