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

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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. However, doing exercise can be very challenging for pwMS who have moderate/severe mobility disability and who have problems with walking. In this project, the investigators will explore 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, the investigators 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 and safe to do on a regular basis. The investigators will also explore whether training with an Exoskeleton can improve walking. The investigators will train 12 patients with MS to walk with an Exoskeleton twice a week for 8 weeks. The investigators will compare the effects with another group of 12 patients who will do exercises with a fitness instructor twice a week for 8 weeks. The investigators will study whether walking with Exoskeleton is better than fitness training in terms of fitness outcomes, walking and cognitive, psychological factors.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of MS as per the McDonald criteria (Polman et al., 2011).

• Age 18 years or older.

• Cognitive ability to give consent and participate in the protocol.

• Walking limitations with Expanded Disability Status Scale (EDSS) scores ranging from 5.0 to 7.5.

• Enough strength in hands and shoulders to support themselves standing and walking using crutches or a walker.

• Meet the general requirements to fit with the Phoenix Exoskeleton (160-190.5 cm in height, weight below 80 Kg, hip width no greater than 42.7 cm measured when sitting, healthy skin where it touches Phoenix Exoskeleton).

• Able to tolerate exercise twice per week as judged by the PI during screening.

Locations
Other Locations
United Kingdom
sheffield teching hospital NHS foundation trust
RECRUITING
Sheffield
Contact Information
Primary
Krishnan Padmakumari Sivaraman Nair
siva.nair@nhs.net
44114271269
Backup
Emma Fargher
emma.fargher@nhs.net
Time Frame
Start Date: 2022-06-23
Estimated Completion Date: 2024-10-30
Participants
Target number of participants: 24
Treatments
Placebo_comparator: Standard Exercise Training Programme
Participants will receive interventions by an exercise specialist based on the participant's tolerance. These sessions will be delivered by a exercise specialist.
Active_comparator: Exoskeleton Exercise Programme
The Phoenix Exoskeleton suit will be used in this study. It is a powered Exoskeleton, with a modular design. Participants will receive interventions by an research physiotherapist based on the participant's tolerance.
Sponsors
Leads: Sheffield Teaching Hospitals NHS Foundation Trust

This content was sourced from clinicaltrials.gov