- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02508961
WEB-Based Physiotherapy for People With Multiple Sclerosis (WEB-PaMS)
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.
Study Overview
Detailed Description
Following baseline assessments, both groups will be given an appointment with the physiotherapist to agree shared goals and to devise an individualised exercise programme based upon their needs and treatment goals. Participants will then be randomised to one of two groups.
Participants randomised to the intervention group will receive their individualised exercise programme delivered via the web-based physio website. Participants will be asked to complete their exercise programme at least twice weekly. They will receive weekly standardised phone calls from the physiotherapist for the first two weeks of the programme. Every two weeks thereafter for the remainder of the 6 month intervention period the physiotherapist will review the exercise diary of each participant and remotely alter the participant's exercise programme as appropriate, by changing any combination of exercises, level of difficulty or number of repetitions. The number and type of exercises within the programme and duration to complete the exercise programme will be documented. Participants will be informed of any changes by standardised email.
Participants randomised to the control group will receive a print out exercise sheet of their individualised exercise programme. Participants will be asked to complete their exercise programme at least twice weekly. Compliance will be captured using a home exercise diary. Participants will also receive a weekly phone call from the physiotherapist for the first two weeks to check on progress.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Edinburgh, United Kingdom, EH16 4SB
- Anne Rowling Regenerative Neurology Clinic
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Irvine, United Kingdom, KA128SS
- Douglas Grant Rehabilitation Centre
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Plymouth, United Kingdom, PL6 8BH
- University of Plymouth
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Web-based physio
Participants 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.
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web-based physio exercise programme
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ACTIVE_COMPARATOR: Print-out exercise programme
Participants 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.
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web-based physio exercise programme
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compliance to the exercise programme
Time Frame: 9 months
|
Number of completed exercise diary entries
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9 months
|
Two Minute Walk Test
Time Frame: 9 months
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Timed 25 Foot Walk
Time Frame: 9 months
|
9 months
|
|
Timed Up and Go
Time Frame: 9 months
|
9 months
|
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Berg Balance Scale
Time Frame: 9 months
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9 months
|
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Physical Activity
Time Frame: 9 months
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Measured using the activPAL physical activity monitor
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9 months
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MS-Related Symptom Checklist
Time Frame: 9 months
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9 months
|
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Multiple Sclerosis Impact Scale
Time Frame: 9 months
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9 months
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Hospital Anxiety and Depression Scale
Time Frame: 9 months
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9 months
|
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Health related quality of life
Time Frame: 9 months
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EQ-5D
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9 months
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15/WS/0030
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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