Actively Recruiting
Acceptability of Exoskeleton Assisted Walking for Persons With Mobility Issues Due to Multiple Sclerosis
Led by Sheffield Teaching Hospitals NHS Foundation Trust · Updated on 2024-05-29
24
Participants Needed
1
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Acceptability of Exoskeleton Assisted Walking for Persons With Mobility Issues Due to Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of MS as per the McDonald criteria (Polman et al., 2011)
- Age 18 years or older
- Cognitive ability to give consent and participate
- Walking limitations with EDSS scores from 5.0 to 7.5
- Enough hand and shoulder strength to support standing and walking with crutches or a walker
- Meet Phoenix Exoskeleton fit requirements: height 160-190.5 cm, weight under 80 kg, hip width no greater than 42.7 cm, healthy skin where Exoskeleton touches
- Able to tolerate exercise twice per week as judged by the principal investigator during screening
You will not qualify if you...
- Any illness other than MS affecting walking and exercise performance
- Severe cognitive or behavioral impairment
- MS relapses within 3 months before enrollment
- Changes in disease-modifying drugs for MS within 6 months before enrollment
- Botulin toxin injections in lower limbs within the previous 3 months
- Medical contraindications to assisted walking (e.g., cardiovascular issues, weight-bearing restrictions, osteoporosis, pregnancy, uncontrolled seizures)
- Significant flexion contractures exceeding 35 degrees at the hip or 20 degrees at the knee that prevent Exoskeleton fit
- Psychopathology or other health conditions deemed unsafe for Exoskeleton use by physiotherapist
- Living more than 20 miles from the study location to reduce travel burden
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
sheffield teching hospital NHS foundation trust
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Actively Recruiting
Research Team
K
Krishnan Padmakumari Sivaraman Nair
CONTACT
E
Emma Fargher
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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