StrokeNCT07356687
Effects of rTMS Combined With Dual-Task Gait Training on Walking and Cognition After Stroke
A study testing active rTMS with dual-task training in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- active rTMS with dual-task training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 1 siteHong Kong
- Study dates
- 21 Jan 2026to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Concurrent formal rehabilitation elsewhere
- RMT cannot be determined
- Fails TMS safety screening
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hong Kong, HongKong, HKG
Prof. Marco PANG, +852 2766 7156, marco.pang@polyu.edu.hk
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- active rTMS with dual-task training, sham rTMS with dual-task training
- Keywords
- Dual-task training, rTMS, Post-stroke rehabilitation, Cognitive-motor interference
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active rTMS with dual-task trainingOther
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.
sham rTMS with dual-task trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: active rTMS with dual-task training |
| 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). Receives: Other: sham rTMS with dual-task training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During 12 months post-intervention follow-up
Stride length (cm)
Mean stride length during walking assessed using wearable sensors.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During the 3-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start21 Jan 2026
- Primary completionJun 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Research Grants Council, Hong Kong
- Responsible party
- Principal investigator, Marco Yiu-Chung Pang, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356687
- Sponsor's protocol ID
- HSEARS20250731004
- Status last verified
- Jul 2026
- First submitted
- 30 Dec 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dorsolateral Prefrontal Cortex rTMS Primed Dual-Task Gait Training on Walking and Cognitive Outcomes After Stroke: A Randomized Sham-Controlled Trial
- ClinicalTrials.gov ID
- NCT07356687
- Acronym / sponsor ID
- HSEARS20250731004
- Conditions
- Stroke
- Keywords
- Dual-task training, rTMS, Post-stroke rehabilitation, Cognitive-motor interference
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Research Grants Council, Hong Kong
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active rTMS with dual-task training | Experimental | Other: active rTMS with dual-task trainingParticipants 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) |
| sham rTMS with dual-task training | Active comparator | Other: sham rTMS with dual-task trainingParticipants 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). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Unilateral ischemic or hemorrhagic hemispheric stroke
- Age ≥ 50 years
- -≥ 6 months post-stroke
- Medically stable
- Able to walk independently ≥ 1 minute (assistive device allowed)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active rTMS with dual-task trainingParticipants 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. | Other | active rTMS with dual-task training |
| sham rTMS with dual-task trainingParticipants 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. | Other | sham rTMS with dual-task training |
Primary outcome
Dual-task cost (DTC) of walking speed (%)
Time frame: 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 (%)
Time frame: 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.
13 secondary outcomes
Timed Up and Go (TUG) time (seconds)
Time frame: Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)
Mini-BESTest total score
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
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)
Time frame: During 12 months post-intervention follow-up
Stride length (cm)
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
Time frame: Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)
Cadence (steps/min)
Time frame: Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)
Double support time (%)
Time frame: Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)
Gait Speed (m/s)
Time frame: Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)
Foot Strike Angle (degrees)
Time frame: Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)
Turns - Duration (seconds)
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)
Time frame: Before and after each training session (3 weeks)
Number of participants with adverse events
Time frame: During the 3-week intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active rTMS with dual-task training in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuning LI (+852 66770121, shunli.li@connect.polyu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual-task cost (DTC) of walking speed (%) (time frame: Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.