Clinical trial NCT06769672: Dual-task Training Combined with TDCS on Cognitive-motor Performance and Brain Activity in Stroke Patients
Official title: The Effect of Dual-task Training Combined with TDCS on Cognitive-motor Interference and Related Brain Activity in Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Cortical Excitability
Keywords: Dual-task training
Cognitive-motor interference
tDCS
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 72
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate tDCS combined with cognitive-motor training on dual-task interference during dual-task walking, dual-task foot pedaling and the corresponding alterations of brain activity.

Detailed description: In China, the prevalence of stroke increased by 106.0% (93.7-118.8) between 1990 and 2019, highlighting the persistent and substantial burden of this condition. Post-stroke recovery, particularly the ability to achieve community ambulation, plays a critical role in improving health-related quality of life. Effective community ambulation in daily life requires the ability to dual-task-namely, to perform concurrent tasks requiring attentional resources while maintaining walking function and balance. Emerging evidence suggests that stroke survivors face greater challenges in walking function and dual-task balance compared to their age-matched, able-bodied counterparts. For instance, when tasked with recalling a shopping list while walking, stroke patients exhibit a more pronounced decline in both walking speed and cognitive performance relative to control groups. Given the necessity for stroke survivors to reintegrate into the community, it is imperative to thoroughly investigate this phenomenon of cognitive-motor interference.

Eligibility criteria: Inclusion Criteria:

* a diagnosis of stroke, stroke onset of more than 6 months,
* aged 50 or more,
* capable of following verbal and visual instructions,
* having a Montreal Cognitive Assessment score ≥ 22,
* able to walk for 10 meters with/without a mobility aid,
* community-dwelling, unilateral stroke

Exclusion Criteria:

* neurological disorders, gait-precluding pain or comorbidity,
* receiving any formal rehabilitation training,
* contraindications to exercise (e.g., unstable angina),
* contraindications to fNIRS, MRI, and tDCS (e.g., brain skin injury, pacemaker, metal implants in the brain),
* history of seizure or epilepsy,
* color blindness.
* unable to walk with/without a mobility aid while responsing stimulus by the remote control

Primary outcomes:
measure: Dual-task gait speed
timeFrame: Through study completion, an average of 1 year
measure: Dual-task cognitive performance
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Oxyhemoglobin concentration changes of the brain
timeFrame: Through study completion, an average of 1 year
measure: Dual-task gait performance 1
timeFrame: Through study completion, an average of 1 year
measure: Dual-task gait performance 2
timeFrame: Through study completion, an average of 1 year
measure: Dual-task gait performance 3
timeFrame: Through study completion, an average of 1 year
measure: Dual-task cognitive performance 1
timeFrame: Through study completion, an average of 1 year
measure: Blood oxygenation level changes of the brain
timeFrame: Through study completion, an average of 1 year
measure: Dual-task stride time
timeFrame: Through study completion, an average of 1 year
measure: Dual-task cognitive performance 2
timeFrame: Through study completion, an average of 1 year
Other outcomes:
measure: Dual-task peak angular velocity
timeFrame: Through study completion, an average of 1 year
measure: Dual-task cognitive performance 3
timeFrame: Through study completion, an average of 1 year
measure: Single-task walking speed
timeFrame: Through study completion, an average of 1 year
measure: Balance 1
timeFrame: Through study completion, an average of 1 year
measure: Balance 2
timeFrame: Through study completion, an average of 1 year
measure: Cognitive performance
timeFrame: Through study completion, an average of 1 year
measure: Cognitive performance 1
timeFrame: before the initiation of training
measure: Cognitive performance 2
timeFrame: Through study completion, an average of 1 year
measure: Fall incidence
timeFrame: Through study completion, an average of 1 year
measure: Dual-task walking time
timeFrame: Through study completion, an average of 1 year
measure: Dual-task correct response ratio
timeFrame: Through study completion, an average of 1 year
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
References: