Using an exoskeleton to help people with multiple sclerosis walk

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

This study is testing if using a powered exoskeleton can help people with multiple sclerosis walk better and be more active.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust (other)
• Locations: 1 site (Sheffield, South Yorkshire)
• Trial ID: NCT04786821 on ClinicalTrials.gov

What this trial studies

This project investigates the use of a powered exoskeleton as a tool for exercise in individuals with moderate to severe walking difficulties due to multiple sclerosis (MS). The study aims to assess the acceptability of exoskeleton-assisted walking, which may help improve physical activity levels and manage symptoms associated with MS. Participants will engage in training sessions using the Phoenix Exoskeleton suit, alongside standard exercise training, to evaluate the potential benefits of this innovative approach. The study focuses on individuals who meet specific eligibility criteria related to their MS diagnosis and mobility limitations.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of multiple sclerosis and moderate to severe walking limitations.

Not a fit: Patients with other illnesses affecting walking or severe cognitive impairments may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance mobility and overall quality of life for patients with multiple sclerosis.

How similar studies have performed: Other studies have shown promise in using exoskeletons for rehabilitation, suggesting potential benefits for similar approaches.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Any illness, other than MS, affecting walking and exercise performance.
* Severe cognitive or behavioral impairment.
* 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.
* Any medical contraindications to assisted walking (e.g., cardiovascular condition, weight-bearing restrictions, osteoporosis or other fracture risk, pregnancy, uncontrolled seizure).
* Significant flexion contractures limited to 35 degrees at the hip and 20 degrees at the knee that precluded Phoenix Exoskeleton fit.
* Psychopathology or other health conditions that the physiotherapist, in his or her clinical judgement, considers to be exclusionary to safely use an Exoskeleton.
* Living more than 20 miles away from the experiment location to reduce burden on patients due to the number of planned study visits.

Where this trial is running

Sheffield, South Yorkshire

• sheffield teching hospital NHS foundation trust — Sheffield, South Yorkshire, United Kingdom (RECRUITING)

Study contacts

• Principal investigator: Krishnan Padmakumari Sivaraman Nair — Sheffield Teaching Hospitals NHS Foundation Trust
• Study coordinator: Krishnan Padmakumari Sivaraman Nair

Conditions: Multiple Sclerosis, Pathologic Processes, Sclerosis, Autoimmune Diseases of the Nervous System, Demyelinating Autoimmune Diseases, CNS, Autoimmune Diseases, Exoskeleton Device, Exercise Programme