Dual-task Training Combined With tDCS on Cognitive-motor Performance and Brain Activity in Stroke Patients (dual-task tDCS)
The Effect of Dual-task Training Combined With tDCS on Cognitive-motor Interference and Related Brain Activity in Stroke Patients
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Prof. Marco PANG
- Phone Number: +852 2766 7156
- Email: marco.pang@polyu.edu.hk
Study Locations
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-
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Hong Kong, Hong Kong
- Recruiting
- The Hong Kong Polytechnic University
-
Contact:
- Marco Yiu-Chung Pang
- Phone Number: +852 2766 7156
- Email: marco.pang@polyu.edu.hk
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: active tDCS combined with dual-task group
patients receive three active tDCS and three dual motor-cognitive exercise training per week for four weeks.
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participants receive three 20-minute active tDCS treatment and three 60-minute COGMOTION dual-task exercise sessions per week for four consecutive weeks.
|
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Active Comparator: sham tDCS combined with dual-task group
Patients receive three sham tDCS and three dual cognitive-motor exercise training per week for four weeks.
|
participants receive three 20-minute sham tDCS treatment and three 60-minute COGMOTION dual-task exercise sessions per week for four consecutive weeks.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dual-task gait speed
Time Frame: Through study completion, an average of 1 year
|
Gait speed under dual-task condition will be recorded
|
Through study completion, an average of 1 year
|
|
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
|
Through study completion, an average of 1 year
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dual-task gait performance 1
Time Frame: Through study completion, an average of 1 year
|
Gait cadence will be measured during dual-task walking
|
Through study completion, an average of 1 year
|
|
Oxyhemoglobin concentration changes of the brain
Time Frame: Through study completion, an average of 1 year
|
Oxyhemoglobin concentration changes will be measured using functional near infra-red spectroscopy during dual-task walking
|
Through study completion, an average of 1 year
|
|
Dual-task gait performance 2
Time Frame: Through study completion, an average of 1 year
|
Gait cycle duration will be measured during dual-task walking
|
Through study completion, an average of 1 year
|
|
Dual-task gait performance 3
Time Frame: Through study completion, an average of 1 year
|
Stride length will be measured during dual-task walking
|
Through study completion, an average of 1 year
|
|
Dual-task cognitive performance 1
Time Frame: Through study completion, an average of 1 year
|
Correct reaction time under dual-task walking will be recorded
|
Through study completion, an average of 1 year
|
|
Blood oxygenation level changes of the brain
Time Frame: Through study completion, an average of 1 year
|
Blood oxygenation level changes will be measured using Magnetic Resonance Imaging during dual-task foot pedaling
|
Through study completion, an average of 1 year
|
|
Dual-task cognitive performance 2
Time Frame: Through study completion, an average of 1 year
|
Number of correct responses under dual-task foot pedaling will be recorded
|
Through study completion, an average of 1 year
|
|
Dual-task stride time
Time Frame: Through study completion, an average of 1 year
|
cadence under dual-task foot pedaling will be recorded
|
Through study completion, an average of 1 year
|
|
Dual-task gait performance 4
Time Frame: Through study completion, an average of 1 year
|
Step time under dual-task walking will be recorded
|
Through study completion, an average of 1 year
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Single-task walking speed
Time Frame: Through study completion, an average of 1 year
|
10-meter walking test will be used to assess single-task walking speed in meters per second
|
Through study completion, an average of 1 year
|
|
Balance 1
Time Frame: Through study completion, an average of 1 year
|
Mini Balance Evaluation Systems Test will be used to assess postural control, with total points from 0-28.
Higher points indicate better performance.
|
Through study completion, an average of 1 year
|
|
Balance 2
Time Frame: Through study completion, an average of 1 year
|
Activities-specific Balance Confidence Scale will be used to assess confidence of functional balance performance, with total points from 0-100.
Higher points indicate better performance.
|
Through study completion, an average of 1 year
|
|
Cognitive performance
Time Frame: Through study completion, an average of 1 year
|
Stroop color word test will be used to assess executive function
|
Through study completion, an average of 1 year
|
|
Fall incidence
Time Frame: Through study completion, an average of 1 year
|
Monthly telephone interviews for recording fall incidence
|
Through study completion, an average of 1 year
|
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Dual-task peak angular velocity
Time Frame: Through study completion, an average of 1 year
|
Peak angular (dorsi-plantar flexion) velocity under dual-task foot pedaling will be recorded
|
Through study completion, an average of 1 year
|
|
Dual-task cognitive performance 3
Time Frame: Through study completion, an average of 1 year
|
Correct reaction time under dual-task foot pedaling will be recorded
|
Through study completion, an average of 1 year
|
|
Cognitive performance 1
Time Frame: before the initiation of training
|
Montreal Cognitive Assessment will be used to assess global cognition, with total points from 0-30.
Higher points indicate better performance.
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before the initiation of training
|
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Cognitive performance 2
Time Frame: Through study completion, an average of 1 year
|
Trail Making Test will be used to assess executive function
|
Through study completion, an average of 1 year
|
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dual-task walking performance at maximal speed
Time Frame: Through study completion, an average of 1 year
|
Walking time under dual-task walking at maximal speed will be recorded
|
Through study completion, an average of 1 year
|
|
dual-task cognitive performance at maximal speed
Time Frame: Through study completion, an average of 1 year
|
Accuracy under dual-task walking at maximal speed will be recorded
|
Through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- Marco PANG_tDCS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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