Lisa M Bunn1, Jonathan F Marsden2, Paola Giunti3, Brian L Day4. 1. Sobell Department of Motor Neuroscience and Movement Disorders, UCL Institute of Neurology, London, UK School of Health Professions, Peninsula Allied Health Centre, University of Plymouth, Plymouth, UK bunn_lisa@hotmail.com. 2. School of Health Professions, Peninsula Allied Health Centre, University of Plymouth, Plymouth, UK. 3. Department of Molecular Neuroscience, UCL Institute of Neurology, London, UK. 4. Sobell Department of Motor Neuroscience and Movement Disorders, UCL Institute of Neurology, London, UK.
Abstract
OBJECTIVE: To investigate the feasibility of a randomized controlled trial of a home-based balance intervention for people with cerebellar ataxia. DESIGN: A randomized controlled trial design. SETTING: Intervention and assessment took place in the home environment. PARTICIPANTS: A total of 12 people with spinocerebellar ataxia type 6 were randomized into a therapy or control group. Both groups received identical assessments at baseline, four and eight weeks. INTERVENTIONS: Therapy group participants undertook balance exercises in front of optokinetic stimuli during weeks 4-8, while control group participants received no intervention. MAIN MEASURES: Test-retest reliability was analysed from outcome measures collected twice at baseline and four weeks later. Feasibility issues were evaluated using daily diaries and end trial exit interviews. RESULTS: The home-based training intervention with opto-kinetic stimuli was feasible for people with pure ataxia, with one drop-out. Test-retest reliability is strong (intraclass correlation coefficient >0.7) for selected outcome measures evaluating balance at impairment and activity levels. Some measures reveal trends towards improvement for those in the therapy group. Sample size estimations indicate that Bal-SARA scores could detect a clinically significant change of 0.8 points in this functional balance score if 80 people per group were analysed in future trials. CONCLUSIONS: Home-based targeted training of functional balance for people with pure cerebellar ataxia is feasible and the outcome measures employed are reliable.
RCT Entities:
OBJECTIVE: To investigate the feasibility of a randomized controlled trial of a home-based balance intervention for people with cerebellar ataxia. DESIGN: A randomized controlled trial design. SETTING: Intervention and assessment took place in the home environment. PARTICIPANTS: A total of 12 people with spinocerebellar ataxia type 6 were randomized into a therapy or control group. Both groups received identical assessments at baseline, four and eight weeks. INTERVENTIONS: Therapy group participants undertook balance exercises in front of optokinetic stimuli during weeks 4-8, while control group participants received no intervention. MAIN MEASURES: Test-retest reliability was analysed from outcome measures collected twice at baseline and four weeks later. Feasibility issues were evaluated using daily diaries and end trial exit interviews. RESULTS: The home-based training intervention with opto-kinetic stimuli was feasible for people with pure ataxia, with one drop-out. Test-retest reliability is strong (intraclass correlation coefficient >0.7) for selected outcome measures evaluating balance at impairment and activity levels. Some measures reveal trends towards improvement for those in the therapy group. Sample size estimations indicate that Bal-SARA scores could detect a clinically significant change of 0.8 points in this functional balance score if 80 people per group were analysed in future trials. CONCLUSIONS: Home-based targeted training of functional balance for people with pure cerebellar ataxia is feasible and the outcome measures employed are reliable.
Authors: Brigitte K Paap; Sandra Roeske; Alexandra Durr; Ludger Schöls; Tetsuo Ashizawa; Sylvia Boesch; Lisa M Bunn; Martin B Delatycki; Paola Giunti; Stéphane Lehéricy; Caterina Mariotti; Jörg Melegh; Massimo Pandolfo; Chantal M E Tallaksen; Dagmar Timmann; Shoji Tsuji; Jörg Bela Schulz; Bart P van de Warrenburg; Thomas Klockgether Journal: Mov Disord Clin Pract Date: 2016-02-11