The Effects of Transcranial Direct Current Stimulation and Cognitive Behavioural Programme on Post-stroke Fatigue
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Fatigue Assessment Scale
Study Overview
Brief Summary
This study aims to evaluate the effect of transcranial direct current stimulation and cognitive behavioural programme on fatigue and its related outcomes among people with stroke.
Detailed Description
This study will adopt a randomized controlled trial. Participants will be randomized into one of the 3 groups. One group will receive transcranial direct current stimulation and cognitive behavioural programme with home-based physical training. Another group will receive sham transcranial direct current stimulation and cognitive behavioural programme with home-based physical training. One group will receive home-based physical training only.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •diagnosed with stroke at least 6 months ago
- •Fatigue Assessment Scale score ≥20
- •cognitively intact
Exclusion Criteria
- •Unstable medical conditions leading to fatigue
- •Under any clinical trials
- •with any other neurological diseases
- •history of transient ischemic attack
- •Contraindications to tDCS
Arms & Interventions
tDCS and cognitive behavioural programme with physical training
Intervention: tDCS & cognitive behavioral programme with home-based physical training (Combination Product)
sham tDCS and cognitive behavioural programme with physical training
Intervention: sham tDCS & cognitive behavioral programme with home-based physical training (Behavioral)
physical training
Intervention: physical training (Behavioral)
Outcomes
Primary Outcomes
Fatigue Assessment Scale
Time Frame: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention
Secondary Outcomes
- Pittsburgh Sleep Quality Index(baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention)
- Geriatric Depression Scale(baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention)
- Reintegration to Normal Living Index(baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention)
- Cardio-ankle vascular index(baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention)
- performance fatigue index(baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention)
- psychomotor vigilance task(baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention)
Investigators
Shamay Ng
Prof
The Hong Kong Polytechnic University