Transcranial Direct Current Stimulation and Cognitive Behavioural Programme on Post-stroke Fatigue

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorThe Hong Kong Polytechnic University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

diagnosed with stroke at least 6 months ago

Fatigue Assessment Scale score ≥20

cognitively intact

Disqualifiers

Unstable medical conditions leading to fatigue

Under any clinical trials

with any other neurological diseases

history of transient ischemic attack

Trial design

Design model

Parallel

Treatments tested in this trial

  • tDCS & cognitive behavioral programme with home-based physical training

    Combination product

    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.

  • sham tDCS & cognitive behavioral programme with home-based physical training

    Behavioral

    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.

  • physical training

    Behavioral

    Participants will have physical training at home for 8 weeks.

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: tDCS and cognitive behavioural programme with physical trainingExperimental treatment 1 intervention
Group B: sham tDCS and cognitive behavioural programme with physical trainingActive comparator 1 intervention
Group C: physical trainingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

Pittsburgh Sleep Quality Index

Time frame
baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention
2

Geriatric Depression Scale

Time frame
baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention
3

Reintegration to Normal Living Index

Time frame
baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention
4

Cardio-ankle vascular index

Time frame
baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention

Other outcomes

Sponsors and contacts

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