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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Rehabilitation for ataxia study: Protocol for a randomised controlled trial of an outpatient and supported home-based physiotherapy programme for people with hereditary cerebellar ataxia
BMJ Open, Volume 10, No. 12, Article e040230, Year 2020
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Description
Introduction Emerging evidence indicates that rehabilitation can improve ataxia, mobility and independence in everyday activities in individuals with hereditary cerebellar ataxia. However, with the rarity of the genetic ataxias and known recruitment challenges in rehabilitation trials, most studies have been underpowered, non-randomised or non-controlled. This study will be the first, appropriately powered randomised controlled trial to examine the efficacy of an outpatient and home-based rehabilitation programme on improving motor function for individuals with hereditary cerebellar ataxia. Methods and analysis This randomised, single-blind, parallel group trial will compare a 30-week rehabilitation programme to standard care in individuals with hereditary cerebellar ataxia. Eighty individuals with a hereditary cerebellar ataxia, aged 15 years and above, will be recruited. The rehabilitation programme will include 6 weeks of outpatient land and aquatic physiotherapy followed immediately by a 24-week home exercise programme supported with fortnightly physiotherapy sessions. Participants in the standard care group will be asked to continue their usual physical activity. The primary outcome will be the motor domain of the Functional Independence Measure. Secondary outcomes will measure the motor impairment related to ataxia, balance, quality of life and cost-effectiveness. Outcomes will be administered at baseline, 7 weeks, 18 weeks and 30 weeks by a physiotherapist blinded to group allocation. A repeated measures mixed-effects linear regression model will be used to analyse the effect of the treatment group for each of the dependent continuous variables. The primary efficacy analysis will follow the intention-to-treat principle. Ethics and dissemination The study has been approved by the Monash Health Human Research Ethics Committee (HREC/18/MonH/418) and the Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research (2019/3503). Results will be published in peer-reviewed journals, presented at national and/or international conferences and disseminated to Australian ataxia support groups. Trial registration number ACTRN12618000908235. ©
Authors & Co-Authors
Burns, Joshua M.
Australia, Sydney
The University of Sydney
Grobler, Anneke C.
Australia, Melbourne
University of Melbourne
Australia, Melbourne
Murdoch Children's Research Institute
Williams, Shannon
Australia, Perth
Royal Perth Hospital
Australia, Perth
Sir Charles Gairdner Hospital
Lamont, Phillipa J.
Australia, Perth
Royal Perth Hospital
Sue, Carolyn M.
Australia, Sydney
Royal North Shore Hospital
Australia, Sydney
The University of Sydney
Dalziel, Kim M.
Australia, Melbourne
University of Melbourne
Statistics
Citations: 11
Authors: 6
Affiliations: 10
Identifiers
Doi:
10.1136/bmjopen-2020-040230
ISSN:
20446055
Research Areas
Disability
Genetics And Genomics
Study Design
Randomised Control Trial