ACTIVATE V1
Research type
Research Study
Full title
Acceptability and clinical trial feasibility evaluation of auditory rhythmical cueing to improve gait and physical activity in community dwelling stroke survivors
IRAS ID
239046
Contact name
Sarah Moore
Contact email
Sponsor organisation
Northumbria Healthcare NHS Foundation Trust
Duration of Study in the UK
2 years, 2 months, 29 days
Research summary
Study aim: To confirm the acceptability of a home-based auditory rhythmical cueing (ARC)treatment to improve gait and physical activity after stroke and to assess the feasibility of a multi-centre, observer blind parallel group randomised controlled trial (RCT) of the ARC treatment.
Study design: Before and after study followed by a multi-centre observer blind, parallel group, pragmatic pilot randomised controlled trial.
Study setting: Home and community settings in North East England.
Study participants: Adult community dwelling stroke survivors with the ability to walk 10 metres with/without a stick indoors who are not undertaking active physiotherapy, are able to comply with the intervention and have a gait-related impairment that would potentially benefit from the intervention. 12 participants will be recruited to the before and after study (8 intervention and 4 controls) and 60 to the RCT.
Study treatments to be used in the before and after study and RCT:
Intervention treatment: Participants will undertake 18 ARC home and community treatment sessions over six weeks (3 x 30 minutes per week, 6 supervised by a study provider/12 self-managed. During the treatment sessions a metronome will be used to provide auditory rhythmic cueing during a series of balance and gait exercises which will gradually be progressed over the six week programme. Training handouts and videos will be provided to support the self-management treatment sessions.Control treatment: Participants in the control group will undertake the same duration balance and gait exercise treatment as the intervention group but without ARC.
Study outcomes: The before and after study will confirm the acceptability of the study treatments. The RCT will then test the feasibility of the study protocol (recruitment, retention, adverse events, treatment delivery, outcome measures) and provide data to inform the design of a future multi-centre RCT.
Study duration: 28 months.REC name
London - City & East Research Ethics Committee
REC reference
18/LO/0115
Date of REC Opinion
22 Jan 2018
REC opinion
Favourable Opinion