A guided self-management programme to reduce falls and improve quality of life, balance and mobility in people with secondary progressive Multiple Sclerosis: a feasibility randomised controlled trial

Plymouth Hospitals NHS Trust0 个研究点目标入组 56 人开始时间: 2016年9月29日最近更新: 2023年10月23日

适应症

试验速览

2017 Protocol article in https://pubmed.ncbi.nlm.nih.gov/28770099/ protocol 2018 Abstract results in https://journals.sagepub.com/doi/full/10.1177/1352458518771862 preliminary results presented at Rehabilitation in Mutiple Sclerosis (RIMS) Conference (added 22/03/2019) 2019 Abstract results in https://www.physiotherapyjournal.com/article/S0031-9406(18)30624-2/abstract preliminary results presented at the Physiotherapy UK Conference 2018 (added 22/03/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31217069 results (added 21/06/2019) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33390184/ (added 10/10/2023)

•1. Confirmed diagnosis of secondary progressive MS (SPMS) as determined by neurologist's opinion
•2. Aged 18 years or older
•3. Willing and able to understand/comply with all trial activities
•4. Expanded Disability Status Scale (EDSS) = 4.0 = 7.0 ie: those people who at best have difficulty waliking 500 metres without aid or rest; and at worst are unable to walk more than 5 metres even with an aid
•5. Self-report two or more falls in the past six months
•6. Willing and able to travel to and participate in BRiMS group sessions in local centres and to commit to undertaking their individualised home-based programme
•7. Access to a computer or tablet and to the internet

•1. Patient report of relapse or having received steroid treatment within the last month
•2. Any recent changes in disease-modifying therapies. More specifically patients will be excluded if:
•2.1. They have ever had previous treatment with Alemtuzemab (Lemtrada / Campath)
•2.2. Ceased Nataluzimab (Tysabri) in the last 6 months
•2.3. Within three months of ceasing any other MS disease-modifying drug
•3. Participated in a falls management programme (e.g. for older people) within the past six months
•4. Co-morbidities which may influence the ability of individuals to participate safely in the programme or likely to impact on the trial (e.g. uncontrolled epilepsy)

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