Stroke
Conditions
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.
Interventions
COMBINATION_PRODUCTtDCS & cognitive behavioral programme with home-based physical training
Participants will receive 16 sessions of tDCS and 7 sessions of cognitive behavioral programme over 8 weeks and have physical training at home for 8 weeks.
BEHAVIORALsham tDCS & cognitive behavioral programme with home-based physical training
Participants will receive 16 sessions of sham-tDCS and 7 sessions of cognitive behavioral programme over 8 weeks and have physical training at home for 8 weeks.
BEHAVIORALphysical training
Participants will have physical training at home for 8 weeks.
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue Assessment Scale | baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Hong Kong
Contacts
CONTACTShamay NG
Outcome results
None listed