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WEB-Based Physiotherapy for People With Multiple Sclerosis (WEB-PaMS)

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Exercise
Sponsored by
University of Glasgow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Physical Activity, Exercise, Physiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Anne Rowling Regenerative Neurology Clinic
  • Douglas Grant Rehabilitation Centre
  • University of Plymouth

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Web-based physio

Print-out exercise programme

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Compliance to the exercise programme
Number of completed exercise diary entries
Two Minute Walk Test

Secondary Outcome Measures

Timed 25 Foot Walk
Timed Up and Go
Berg Balance Scale
Physical Activity
Measured using the activPAL physical activity monitor
MS-Related Symptom Checklist
Multiple Sclerosis Impact Scale
Hospital Anxiety and Depression Scale
Health related quality of life
EQ-5D

Full Information

First Posted
July 23, 2015
Last Updated
May 30, 2017
Sponsor
University of Glasgow
Collaborators
National Heatlh Service Ayrshire and Arran, NHS Lothian, University of Plymouth, University Hospital Plymouth NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02508961
Brief Title
WEB-Based Physiotherapy for People With Multiple Sclerosis
Acronym
WEB-PaMS
Official Title
WEB-Based Physiotherapy for People With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Glasgow
Collaborators
National Heatlh Service Ayrshire and Arran, NHS Lothian, University of Plymouth, University Hospital Plymouth NHS Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Physical Activity, Exercise, Physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Web-based physio
Arm Type
Experimental
Arm Description
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.
Arm Title
Print-out exercise programme
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
web-based physio exercise programme
Primary Outcome Measure Information:
Title
Compliance to the exercise programme
Description
Number of completed exercise diary entries
Time Frame
9 months
Title
Two Minute Walk Test
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Timed 25 Foot Walk
Time Frame
9 months
Title
Timed Up and Go
Time Frame
9 months
Title
Berg Balance Scale
Time Frame
9 months
Title
Physical Activity
Description
Measured using the activPAL physical activity monitor
Time Frame
9 months
Title
MS-Related Symptom Checklist
Time Frame
9 months
Title
Multiple Sclerosis Impact Scale
Time Frame
9 months
Title
Hospital Anxiety and Depression Scale
Time Frame
9 months
Title
Health related quality of life
Description
EQ-5D
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Anne Rowling Regenerative Neurology Clinic
City
Edinburgh
ZIP/Postal Code
EH16 4SB
Country
United Kingdom
Facility Name
Douglas Grant Rehabilitation Centre
City
Irvine
ZIP/Postal Code
KA128SS
Country
United Kingdom
Facility Name
University of Plymouth
City
Plymouth
ZIP/Postal Code
PL6 8BH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30907159
Citation
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.
Results Reference
derived

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WEB-Based Physiotherapy for People With Multiple Sclerosis

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