Dual-task Training Combined With tDCS on Cognitive-motor Performance and Brain Activity in Stroke Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorThe Hong Kong Polytechnic University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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),
Trial design
Design model
Parallel
Treatments tested in this trial
active tDCS with dual-task training
Other interventionparticipants receive three 20-minute active tDCS treatment and three 60-minute COGMOTION dual-task exercise sessions per week for four consecutive weeks.
sham tDCS with dual-task training
Other interventionparticipants receive three 20-minute sham tDCS treatment and three 60-minute COGMOTION dual-task exercise sessions per week for four consecutive weeks.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: active tDCS combined with dual-task groupExperimental treatment 1 intervention
Group B: sham tDCS combined with dual-task groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Dual-task gait speed
Gait speed under dual-task condition will be recorded
Time frame
Through study completion, an average of 1 year2
Dual-task cognitive performance
Number of correct responses will be measured during dual-task conditions
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
Oxyhemoglobin concentration changes of the brain
Oxyhemoglobin concentration changes will be measured using functional near infra-red spectroscopy during dual-task walking
Time frame
Through study completion, an average of 1 year2
Dual-task gait performance 1
Gait cadence will be measured during dual-task walking
Time frame
Through study completion, an average of 1 year3
Dual-task gait performance 2
Gait cycle duration will be measured during dual-task walking
Time frame
Through study completion, an average of 1 year4
Dual-task gait performance 3
Stride length will be measured during dual-task walking
Time frame
Through study completion, an average of 1 yearOther outcomes
1
Dual-task peak angular velocity
Peak angular (dorsi-plantar flexion) velocity under dual-task foot pedaling will be recorded
Time frame
Through study completion, an average of 1 year2
Dual-task cognitive performance 3
Correct reaction time under dual-task foot pedaling will be recorded
Time frame
Through study completion, an average of 1 year3
Single-task walking speed
10-meter walking test will be used to assess single-task walking speed in meters per second
Time frame
Through study completion, an average of 1 year4
Balance 1
Mini Balance Evaluation Systems Test will be used to assess postural control, with total points from 0-28. Higher points indicate better performance.
Time frame
Through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov