WEB-Based Physiotherapy for People With Multiple Sclerosis

NCT ID: NCT02508961

Last Updated: 2017-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-12-31

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

web-based physio exercise programme

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.

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: BEHAVIORAL

web-based physio exercise programme

Interventions

Exercise

web-based physio exercise programme

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heatlh Service Ayrshire and Arran

OTHER_GOV

Sponsor Role: collaborator

NHS Lothian

OTHER_GOV

Sponsor Role: collaborator

University of Plymouth

OTHER

Sponsor Role: collaborator

University Hospital Plymouth NHS Trust

OTHER

Sponsor Role: collaborator

University of Glasgow

OTHER

Sponsor Role: lead

Responsible Party

Dr Lorna Paul

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Anne Rowling Regenerative Neurology Clinic

Edinburgh, , United Kingdom

Douglas Grant Rehabilitation Centre

Irvine, , United Kingdom

University of Plymouth

Plymouth, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 30907159 (View on PubMed)

Other Identifiers

15/WS/0030

Identifier Type: -

Identifier Source: org_study_id