WEB-Based Physiotherapy for People With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— WEB-PaMS  

Official title:

WEB-Based Physiotherapy for People With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02508961
• Other study ID #: 15/WS/0030
• Status: Completed
• Phase: N/A
• First received: July 23, 2015
• Last updated: May 30, 2017
• Start date: January 2015
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: University of Glasgow
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Exercise
web-based physio exercise programme

Locations

Country	Name	City	State
United Kingdom	Anne Rowling Regenerative Neurology Clinic	Edinburgh
United Kingdom	Douglas Grant Rehabilitation Centre	Irvine
United Kingdom	University of Plymouth	Plymouth

Sponsors (5)

Lead Sponsor	Collaborator
University of Glasgow	National Heatlh Service Ayrshire and Arran, NHS Lothian, Plymouth Hospitals NHS Trust, University of Plymouth

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance to the exercise programme	Number of completed exercise diary entries	9 months
Primary	Two Minute Walk Test		9 months
Secondary	Timed 25 Foot Walk		9 months
Secondary	Timed Up and Go		9 months
Secondary	Berg Balance Scale		9 months
Secondary	Physical Activity	Measured using the activPAL physical activity monitor	9 months
Secondary	MS-Related Symptom Checklist		9 months
Secondary	Multiple Sclerosis Impact Scale		9 months
Secondary	Hospital Anxiety and Depression Scale		9 months
Secondary	Health related quality of life	EQ-5D	9 months