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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
184
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.
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.
The Hong Kong Polytechnic University
Hong Kong, HongKong, Hong Kong
RECRUITINGDual-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.
Time frame: 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.
Time frame: Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)
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.
Time frame: Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)
Mini-BESTest total score
Mini-BESTest total score assessing dynamic balance; higher score indicates better balance control.
Time frame: 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.
Time frame: 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.
Time frame: During 12 months post-intervention follow-up
Stride length (cm)
Mean stride length during walking assessed using wearable sensors.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During the 3-week intervention period
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