A multi-centre randomised controlled trial to assess the effectiveness and cost effectiveness of a home-based self-management standing frame programme plus usual care versus usual care in people with progressive multiple sclerosis (MS) who have severely impaired balance and mobility

Plymouth Hospitals NHS Trust0 sites140 target enrollmentFebruary 3, 2016

Overview

2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31301748 results (added 16/07/2019) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33115893/ qualitative results (added 30/10/2020) 2016 Protocol article in https://pubmed.ncbi.nlm.nih.gov/27149954/ (added 17/08/2022)

Registry

who.int

Start Date

February 3, 2016

End Date

March 31, 2018

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Individuals diagnosed with primary or secondary progressive MS according to McDonald’s criteria
•2\. Aged 18 years or over
•3\.Willing and able to consent to participate
•4\. Scoring 6\.5\-8\.0 on the Expanded Disability Status Scale (EDSS), i.e. people who require bilateral assistance to walk 20 metres or less” to those restricted to bed or wheelchair”
•5\. Ability of the home / family to accommodate the standing frame
•6\. Able to get into a standing frame independently or with assistance from a carer
•7\. Agreement of another person (e.g. carer) should assistance be necessary for the standing programme
•8\. Willing and able to travel to local assessment centres for blinded outcomes assessment

•1\. Any recent changes in disease modifying therapies (more specifically if they have ever had Campath, are within past 6 months of ceasing Nataluzimab, or are within 3 months of ceasing any other MS disease modifying drug)
•2\. Have relapsed/received steroid treatment within the last month
•3\. Are currently, or during the past 6 months have undertaken a regular standing frame programme(more than once a week)
•4\. Have a history of osteoporotic\-related fractures
•5\. Have comorbidities which contraindicate standing in the frame (e.g. foot ulceration, uncontrolled epilepsy) or likely to impact on the trial (e.g. chronic jaundice, heart disease, age related multiple co\-morbidities)
•6\. Currently participating in another clinical trial (rehabilitation or pharmacological)