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Completed

NCT Number: NCT02508961

WEB-Based Physiotherapy for People With Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Motor Activity Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anne Rowling Regenerative Neurology Clinic, Edinburgh, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise

Behavioral

web-based physio exercise programme

Primary outcomes

  1. Compliance to the exercise programme

    Time frame: 9 months

    Number of completed exercise diary entries

  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

    Time frame: 9 months

    Measured using the activPAL physical activity monitor

  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

    Time frame: 9 months

    EQ-5D

Sponsors and collaborators

Lead sponsor

University of Glasgow

Other

Collaborators

  • NHS Lothian
  • National Heatlh Service Ayrshire and Arran
  • University Hospital Plymouth NHS Trust
  • University of Plymouth

Registry information

Acronym: WEB-PaMS

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 27, 2015
Registry last updated
Jun 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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