SUMS: Standing up in people with multiple sclerosis

Not Applicable

Completed

• Conditions: Topic: Neurological disorders; Subtopic: Neurological (all Subtopics); Disease: Multiple Sclerosis; Nervous System Diseases; Multiple Sclerosis

• Registration Number: ISRCTN69614598
• Lead Sponsor: Plymouth Hospitals NHS Trust

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-03
• Study Completion: 2018-03-31
• Last Update Posted: 29 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Motor function is measured using the Amended Motor Club Assessment at baseline, 20 and 36 weeks.