Clinical trial NCT02508961: WEB-Based Physiotherapy for People With Multiple Sclerosis
Official title: WEB-Based Physiotherapy for People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Physical Activity
Exercise
Physiotherapy
Lead sponsor: University of Glasgow
Sponsor class: OTHER
Collaborators: name: National Heatlh Service Ayrshire and Arran
name: NHS Lothian
name: University of Plymouth
name: University Hospital Plymouth NHS Trust
First posted: 2015-07-27
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Compliance to the exercise programme
timeFrame: 9 months
measure: Two Minute Walk Test
timeFrame: 9 months
Secondary outcomes:
measure: Timed 25 Foot Walk
timeFrame: 9 months
measure: Timed Up and Go
timeFrame: 9 months
measure: Berg Balance Scale
timeFrame: 9 months
measure: Physical Activity
timeFrame: 9 months
measure: MS-Related Symptom Checklist
timeFrame: 9 months
measure: Multiple Sclerosis Impact Scale
timeFrame: 9 months
measure: Hospital Anxiety and Depression Scale
timeFrame: 9 months
measure: Health related quality of life
timeFrame: 9 months
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Anne Rowling Regenerative Neurology Clinic
city: Irvine
country: United Kingdom
facility: Douglas Grant Rehabilitation Centre
city: Plymouth
country: United Kingdom
facility: University of Plymouth
Study officials:
References:
citation: 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.