RecruitingNot ApplicableNCT04786821

Acceptability of Exoskeleton Assisted Walking for Persons With Mobility Issues Due to Multiple Sclerosis

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


Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Enrollment

24 participants

Start Date

Jun 23, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring whether a robotic exoskeleton — a wearable device that supports and assists leg movement — is acceptable and useful for people with multiple sclerosis (MS) who have difficulty walking. Researchers want to understand whether people find exoskeleton-assisted walking practical and worthwhile for their daily lives. **You may be eligible if...** - You have a confirmed MS diagnosis - You are 18 or older - You have significant walking limitations (moderate to severe disability on a standard MS scale) - You have enough arm and shoulder strength to use crutches or a walker - You are between 160–190.5 cm tall and weigh below the device's limit - You are mentally capable of giving consent and following study instructions **You may NOT be eligible if...** - You do not have MS or your walking difficulties fall outside the required disability range - You do not meet the physical size requirements for the exoskeleton Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALStandard Exercise Training

Participants will receive interventions by an exercise specialist for up to 30 minutes based on the participant's tolerance. The exercises used in control group will depend on the individual and their abilities as evaluated in the baseline assessment session. Possible exercises include arm crank, recumbent cycle, and chair exercises. These sessions will be delivered by a member of the research team.

DEVICEPhoenix Exoskeleton suit

Participants will aim to walk wearing the Exoskeleton for up to 30 minutes. Based on the participant's tolerance, the duration of walking can be shorter and can be split into shorter intervals to achieve more activity. Over the sessions, based on the participants' tolerance, gradually the duration of walking can be increased with shorter breaks. This will be delivered by a research physiotherapist.


Locations(1)

sheffield teching hospital NHS foundation trust

Sheffield, South Yorkshire, United Kingdom

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NCT04786821


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