The Effect of Dual-task Training Combined With tDCS on Cognitive-motor Interference and Related Brain Activity in Stroke Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Dual-task gait speed
Study Overview
Brief Summary
This study aims to evaluate the effects of tDCS combined with cognitive-motor training on dual-task interference during walking and foot pedaling, alongside corresponding alterations in brain activity assessed via fNIRS. Additionally, an fMRI component was conducted as a nested sub-study for deep mechanistic exploration.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
active tDCS combined with dual-task group
patients receive three active tDCS and three dual motor-cognitive exercise training per week for four weeks.
Intervention: active tDCS with dual-task training (Other)
sham tDCS combined with dual-task group
Patients receive three sham tDCS and three dual cognitive-motor exercise training per week for four weeks.
Intervention: sham tDCS with dual-task training (Other)
Outcomes
Primary Outcomes
Dual-task gait speed
Time Frame: Through study completion, an average of 1 year
Gait speed under dual-task condition will be recorded
Dual-task cognitive performance
Time Frame: Through study completion, an average of 1 year
Number of correct responses will be measured during dual-task conditions
Dual-task self-paced walking--gait speed
Time Frame: Through study completion, an average of 1 year
Gait speed under dual-task walking condition will be recorded
Dual-task self-paced walking--cognitive performance
Time Frame: Through study completion, an average of 1 year
Number of correct responses will be measured during dual-task conditions
Secondary Outcomes
- Oxyhemoglobin concentration changes of the brain(Through study completion, an average of 1 year)
- Dual-task gait performance 1(Through study completion, an average of 1 year)
- Dual-task gait performance 2(Through study completion, an average of 1 year)
- Dual-task gait performance 3(Through study completion, an average of 1 year)
- Dual-task cognitive performance 1(Through study completion, an average of 1 year)
- Blood oxygenation level changes of the brain(Through study completion, an average of 1 year)
- Dual-task cognitive performance 2(Through study completion, an average of 1 year)
- Dual-task self-paced walking--gait performance 1(Through study completion, an average of 1 year)
- Dual-task self-paced walking--gait performance 2(Through study completion, an average of 1 year)
- Dual-task self-paced walking--gait performance 3(Through study completion, an average of 1 year)
- Dual-task self-paced walking--cognitive performance 1(Through study completion, an average of 1 year)
- Dual-task pedaling--cadence(Through study completion, an average of 1 year)
- Dual-task pedaling--cognitive performance 1(Through study completion, an average of 1 year)
- tDCS adverse event(Through study completion, an average of 1 year)
- Dual-task stride time(Through study completion, an average of 1 year)
- Dual-task gait performance 4(Through study completion, an average of 1 year)