ExoMS Study
Research type
Research Study
Full title
Feasibility study for a randomised control trial for the acceptability of Exoskeleton assisted walking compared to standard exercise training for persons with mobility issues due to multiple sclerosis
IRAS ID
278131
Contact name
Sivaraman Nair
Contact email
Sponsor organisation
Sheffield Teaching Hospitals
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
20833, STH
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Research Summary
Multiple sclerosis (MS) is a chronic, inflammatory disease of the central nervous system. Lack of physical activity is common in people with MS (pwMS). This can lead to several comorbid conditions such as obesity, metabolic syndrome, osteoporosis, hypertension, diabetes and worse prognosis. An increasing number of studies suggest that physical exercise can play an important role in managing symptoms, preventing complications and comorbidities in pwMS, and may possibly be neuroprotective (Giesser, 2015). However, doing exercise can be very challenging for pwMS who have moderate/severe mobility disability and who have problems with walking.
In this project, we will investigate the use of a powered Exoskeleton as an exercise tool for people with moderate to severe difficulty walking due to MS. Powered Exoskeletons are wearable robots that offer opportunity to persons with lower limb weakness to stand and walk. The Exoskeleton-assisted training provides active training with potentially much less intervention needed from therapists.
However, it is not clear whether pwMS can walk with a powered Exoskeleton at speeds and intensities sufficient to positively affect health and fitness outcomes. Thus, in this study, we aim to explore whether using an Exoskeleton will enable people with MS to exercise at a moderate intensity and whether people with MS find this acceptable to do on a regular basis. We will also explore whether training with an Exoskeleton can improve walking.
We will train 12 patients with MS to walk with an Exoskeleton twice a week for 8 weeks. We will compare the effects with another group of 12 patients who will do exercises with a fitness instructor twice a week for 8 weeks. We will study whether walking with Exoskeleton is better than fitness training in terms of fitness outcomes, walking and cognitive, psychological factors.
Summary of Results
The aim of this project was to investigate whether exoskeleton assisted walking practice led to health benefits including improved physical fitness amongst people living with moderate to severe Multiple Sclerosis (MS). The exoskeleton programme was compared with a conventional exercise programme with routine gym equipment. Twenty-four people living with moderate to severe MS were recruited to the trial through out-patient Neurology clinics. Twelve participants were allocated to the exoskeleton programme and the other twelve to the conventional exercise programme. Four participants were unable to start the exoskeleton programme due to changes in their circumstances or health; three participants were unable to start the exercise programme due to changes in their health or living circumstances. Nine participants completed the conventional exercise programme and seven completed the exoskeleton training. One participant had to drop out of the exoskeleton programme due to a fractured wrist which was not related to the project. There were no major adverse incidents during programme delivery with over 90% of sessions attended. Participants engaged well with both the exoskeleton and exercise programmes and reported minimal discomfort during their sessions. We monitored heart rate throughout the sessions. Participant’s heart rate increased during exoskeleton and conventional exercise training; on average, the recorded heart rate was slightly higher during conventional exercise training compared with the exoskeleton programme. We measured physical outcomes including blood pressure, fitness, walking speed and body mass at the start and end of programme for each participant. Small improvements in all physical outcomes were recorded across the exoskeleton and conventional exercise programme participants. The exoskeleton participants achieved greatest improvement in walking speed; the conventional exercise participants achieved greatest improvement in fitness. Quality of life and symptom impact questionnaires were also completed by participants; the results indicated that the conventional exercise programme was associated with improved fatigue symptoms.
REC name
Wales REC 3
REC reference
21/WA/0160
Date of REC Opinion
21 May 2021
REC opinion
Favourable Opinion