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CompletedNCT02508961WEB-PaMSUpdated Jun 1, 2017

WEB-Based Physiotherapy for People With Multiple Sclerosis

An interventional study of Exercise in Multiple Sclerosis, sponsored by University of Glasgow. Completed at 3 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-01.

Sponsored by University of Glasgow · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Jan 2015, registered Jul 2015).
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Multiple Sclerosis

Keywords

  • Physical Activity
  • Exercise
  • Physiotherapy
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 90 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

University of Glasgow is the lead sponsor of 141 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • 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.

    Behavioral: Exercise

  • 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.

    Behavioral: Exercise

Interventions

  • BehavioralExercise

    web-based physio exercise programme

06

What researchers measure

Primary outcomes

  1. Compliance to the exercise programme

    Number of completed exercise diary entries

    Time frame: 9 months

  2. Two Minute Walk Test

    Time frame: 9 months

Secondary outcomes

  1. Timed 25 Foot Walk

    Time frame: 9 months

  2. Timed Up and Go

    Time frame: 9 months

  3. Berg Balance Scale

    Time frame: 9 months

  4. Physical Activity

    Measured using the activPAL physical activity monitor

    Time frame: 9 months

  5. MS-Related Symptom Checklist

    Time frame: 9 months

  6. Multiple Sclerosis Impact Scale

    Time frame: 9 months

  7. Hospital Anxiety and Depression Scale

    Time frame: 9 months

  8. Health related quality of life

    EQ-5D

    Time frame: 9 months

07

Study locations

3 sites
  • 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
08

References and documents

Publications

  • 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. PubMed 30907159 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02508961
Lead sponsor
University of Glasgow
Collaborators
National Heatlh Service Ayrshire and Arran, NHS Lothian, University of Plymouth, University Hospital Plymouth NHS Trust
Responsible party
Dr Lorna Paul (Dr, University of Glasgow) — Principal investigator
First posted
Jul 27, 2015
Start date
Jan 2015
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Jun 1, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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