NCT04786821Completed
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
Source: ClinicalTrials.gov · Last updated 19 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 18 Jan 2021
- Start date
- 23 Jun 2022
- Primary completion date
- 30 Oct 2024
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Diseases
- Multiple sclerosis
- NCT number
- NCT04786821
What you commit to
- Study type: Interventional
- Participants enrolled: 24
- From 23 Jun 2022 to the primary completion date, 30 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Relapses 3 months prior to enrolment.
- Change in disease modifying drugs for MS 6 months before enrolment.
- Botulin toxin injections for the lower limbs the previous 3 months.
Other illness
- Any illness, other than MS, affecting walking and exercise performance.
- Severe cognitive or behavioral impairment.
- Any medical contraindications to assisted walking (e.g., cardiovascular condition, weight-bearing restrictions, osteoporosis or other fracture risk, pregnancy, uncontrolled seizure).
- Psychopathology or other health conditions that the physiotherapist, in his or her clinical judgement, considers to be exclusionary to safely use an Exoskeleton.
Other
- Significant flexion contractures limited to 35 degrees at the hip and 20 degrees at the knee that precluded Phoenix Exoskeleton fit.
- Living more than 20 miles away from the experiment location to reduce burden on patients due to the number of planned study visits.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| sheffield teching hospital NHS foundation trust Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.