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

Launched by SHEFFIELD TEACHING HOSPITALS NHS FOUNDATION TRUST · Mar 3, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the use of a powered Exoskeleton to help people with multiple sclerosis (MS) who have difficulty walking. The Exoskeleton is a wearable robotic device that can assist individuals in standing and walking, which may make it easier for them to exercise and improve their health. The researchers want to find out if using the Exoskeleton allows participants to exercise at a level that benefits their health and fitness, and if they feel safe and comfortable using it. They will compare the effects of training with the Exoskeleton to traditional exercise sessions with a fitness instructor.

To be eligible for the trial, participants need to be at least 18 years old and have a diagnosis of MS with specific walking limitations. They should also have enough strength to support themselves while using the Exoskeleton. The study will involve 12 participants using the Exoskeleton and another 12 doing regular fitness exercises, with both groups training twice a week for 8 weeks. Participants can expect to be part of a supportive environment where their progress will be monitored, and they will help researchers learn more about how technology can assist those with mobility challenges due to MS.

Gender

ALL

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.