WEB-Based Physiotherapy for People With Multiple Sclerosis
WEB-PaMS
1 other identifier
interventional
90
1 country
3
Brief Summary
The study will be a pragmatic, single blind, randomised, controlled feasibility study, comparing 6 months of web-based physiotherapy plus usual care with usual care alone in pwMS. The study will recruit 90 pwMS from three UK Centres (30 from each centre); NHS Ayrshire and Arran, NHS Lothian, and Plymouth Hospitals NHS Trust. The aim of this study is to assess the feasibility of a randomised controlled trial examining the effectiveness of a six-month web-based physiotherapy programme and usual care compared to usual care alone, in people moderately affected by MS and to gather essential information for the planning of a definitive trial, which would evaluate both clinical and cost effectiveness of the intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable multiple-sclerosis
Started Jan 2015
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 23, 2015
CompletedFirst Posted
Study publicly available on registry
July 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJune 1, 2017
May 1, 2017
1.9 years
July 23, 2015
May 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Compliance to the exercise programme
Number of completed exercise diary entries
9 months
Two Minute Walk Test
9 months
Secondary Outcomes (8)
Timed 25 Foot Walk
9 months
Timed Up and Go
9 months
Berg Balance Scale
9 months
Physical Activity
9 months
MS-Related Symptom Checklist
9 months
- +3 more secondary outcomes
Study Arms (2)
Web-based physio
EXPERIMENTALParticipants receive an online individualised exercise programme to complete over the internet twice per week. Exercises can be a combination of aerobic, strengthening and balance exercises. Participants receive a weekly phone call from a physiotherapist for the first two weeks to check on progress. After this, every 2 weeks online exercise diaries are remotely monitored by a physiotherapist and exercise programmes progressed as appropriate.
Print-out exercise programme
ACTIVE COMPARATORParticipants receive printed exercise programme to complete twice per week. Exercises can be a combination of aerobic, strengthening and balance exercises. Participants receive a weekly phone call from a physiotherapist for the first two weeks to check on progress. Participants complete a paper exercise diary and after the first 2 weeks if they require a progression to their exercise programme they contact their physiotherapist.
Interventions
Eligibility Criteria
You may qualify if:
- A confirmed diagnosis of MS
- Known to a MS consultant in NHS Ayrshire and Arran, Lothian or Plymouth Hospitals NHS Trust
- EDSS of 4 - 6.5
- Access to a personal computer/tablet or smart television with an email address and internet connection
You may not qualify if:
- Currently taking part in regular exercise (two or more times per week) and/or a regular physiotherapy programme
- Poor cognitive function as assessed by a Mini Mental State Examination Score (MMSE) \<24
- Any significant change in medication (within the last 3 months)
- Relapse within 3 months requiring treatment
- Other significant co-morbidities for which exercise is contra-indicated
- Unwilling to be randomised to intervention/control group
- Currently participating in another clinical trial (rehabilitation or pharmacological)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Glasgowlead
- National Heatlh Service Ayrshire and Arrancollaborator
- NHS Lothiancollaborator
- University of Plymouthcollaborator
- University Hospital Plymouth NHS Trustcollaborator
Study Sites (3)
Anne Rowling Regenerative Neurology Clinic
Edinburgh, EH16 4SB, United Kingdom
Douglas Grant Rehabilitation Centre
Irvine, KA128SS, United Kingdom
University of Plymouth
Plymouth, PL6 8BH, United Kingdom
Related Publications (1)
Dennett R, Coulter E, Paul L, Freeman J. A qualitative exploration of the participants' experience of a web-based physiotherapy program for people with multiple sclerosis: Does it impact on the ability to increase and sustain engagement in physical activity? Disabil Rehabil. 2020 Oct;42(21):3007-3014. doi: 10.1080/09638288.2019.1582717. Epub 2019 Mar 23.
PMID: 30907159DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
July 23, 2015
First Posted
July 27, 2015
Study Start
January 1, 2015
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
June 1, 2017
Record last verified: 2017-05