Effects of rTMS Combined With Dual-Task Gait Training on Walking and Cognition After Stroke

Effects of Dorsolateral Prefrontal Cortex rTMS Primed Dual-Task Gait Training on Walking and Cognitive Outcomes After Stroke: A Randomized Sham-Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: active rTMS with dual-task training; Other: sham rTMS with dual-task training

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.

• Study Type: Interventional
• Enrollment (Estimated): 184
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Prof. Marco PANG; Phone Number: +852 2766 7156; Email: Marco.Pang@polyu.edu.hk
• Study Contact Backup: Name: Shuning LI; Phone Number: +852 66770121; Email: shunli.li@connect.polyu.hk

Study Locations

• Hong Kong
  • HongKong
    • Hong Kong, HongKong, Hong Kong, HKG
      • Recruiting
      • The Hong Kong Polytechnic University
      • Contact: Prof. Marco PANG; Phone Number: +852 2766 7156; Email: Marco.Pang@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: active rTMS with dual-task training; 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)	Other: active 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.
Active Comparator: sham rTMS with dual-task training; 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).	Other: sham 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)
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)
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)
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
Fall incidence (number of falls)	Number of falls recorded using a fall diary and confirmed during scheduled follow-up contacts.	During 6 months post-intervention follow-up
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)

Other Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: Research Grants Council, Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: December 30, 2025
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: rTMS; Dual-task training; Cognitive-motor interference; Post-stroke rehabilitation
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: HSEARS20250731004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No