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

May 30, 2017 updated by: Dr Lorna Paul, University of Glasgow

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

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Edinburgh, United Kingdom, EH16 4SB
        • Anne Rowling Regenerative Neurology Clinic
      • Irvine, United Kingdom, KA128SS
        • Douglas Grant Rehabilitation Centre
      • Plymouth, United Kingdom, PL6 8BH
        • University of Plymouth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
web-based physio exercise programme
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.
web-based physio exercise programme

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
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
Berg Balance Scale
Time Frame: 9 months
9 months
Physical Activity
Time Frame: 9 months
Measured using the activPAL physical activity monitor
9 months
MS-Related Symptom Checklist
Time Frame: 9 months
9 months
Multiple Sclerosis Impact Scale
Time Frame: 9 months
9 months
Hospital Anxiety and Depression Scale
Time Frame: 9 months
9 months
Health related quality of life
Time Frame: 9 months
EQ-5D
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2015

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

July 23, 2015

First Submitted That Met QC Criteria

July 24, 2015

First Posted (ESTIMATE)

July 27, 2015

Study Record Updates

Last Update Posted (ACTUAL)

June 1, 2017

Last Update Submitted That Met QC Criteria

May 30, 2017

Last Verified

May 1, 2017

More Information

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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