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NCT Number: NCT07356687

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong, HongKong, HKG

Location status: Recruiting

Location contact

Prof. Marco PANG

CONTACT

[email protected]

+852 2766 7156

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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)

    Time in seconds to complete: (1) standard TUG, and (2) cognitive dual-task TUG with serial 3 subtraction. Lower time indicates better functional mobility.

  2. Mini-BESTest total score

    Time frame: 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.

  3. 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)

    Self-reported balance confidence (0-100%); higher score indicates greater confidence during daily activities.

  4. Fall incidence (number of falls)

    Time frame: During 12 months post-intervention follow-up

    Number of falls recorded using a fall diary and confirmed during scheduled follow-up contacts.

  5. Stride length (cm)

    Time frame: 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.

  6. 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)

    RNLI score reflecting community participation and reintegration; higher score indicates better reintegration to normal living.

  7. Cadence (steps/min)

    Time frame: 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.

  8. Double support time (%)

    Time frame: 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.

  9. Gait Speed (m/s)

    Time frame: 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.

  10. Foot Strike Angle (degrees)

    Time frame: 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.

  11. Turns - Duration (seconds)

    Time frame: 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.

  12. Session-level perceived fatigue (0-10 rating)

    Time frame: 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.

  13. Number of participants with adverse events

    Time frame: During the 3-week intervention period

    Number of participants experiencing adverse events related to tms and dual-task gait training.

Other outcomes

  1. Prefrontal cortex hemodynamic response (fNIRS HbO) during walking

    Time frame: Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)

    Changes in bilateral prefrontal cortex oxyhemoglobin (HbO) measured by fNIRS during single- and dual-task walking; used as a mechanistic/mediator outcome.

  2. Depression Anxiety Stress Scales-21 (DASS-21) subscale scores

    Time frame: Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)

    Depression, Anxiety, and Stress subscale scores from DASS-21; higher scores indicate greater emotional distress.

  3. Pittsburgh Sleep Quality Index (PSQI) global score

    Time frame: Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)

    PSQI global score assessing sleep quality; higher score indicates poorer sleep quality.

  4. Fugl-Meyer Assessment-Lower Extremity (FMA-LE) score

    Time frame: Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)

    FMA-LE motor score (0-34); higher score indicates better lower-limb motor recovery.

Study contacts

Contact information is provided by the study sponsor or research team.

Prof. Marco PANG

CONTACT

[email protected]

+852 2766 7156

Shuning LI

CONTACT

[email protected]

+852 66770121

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Research Grants Council, Hong Kong

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jan 21, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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