Rex Robot Assisted Rehabilitation to Enhance Balance and Mobility for People With Multiple Sclerosis, Clinical and Biomarker Study - RAPPER IV

Launched by EAST KENT HOSPITALS UNIVERSITY NHS FOUNDATION TRUST · May 20, 2024

Keywords

ClinConnect Summary

The key research questions:

* Is it feasible for a person with balance and mobility impairment caused by MS to use a robotic walking device to exercise in standing and walking with supervision safely?
* What are the key outcome measures most sensitive to measurable change in this study population sample, which may reflect potential improvement during the trial period? (Clinical outcome scales and self-reported questionnaires)
* Is this robotic assisted balance and mobility training program feasible, safe and effective?
* Does the completion of this balance and mobility exercise treatment i...

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Eligibility criteria

• Inclusion Criteria:
• • • Are aged greater than 18 years and less than 80 years
• • Have a confirmed diagnosis of MS by a Consultant Neurologist as per McDonald Criteria.
• • Have moderate mobility restriction as defined by an Extended Disability Status Scale (EDSS) score of between 4 to 6.5
• • Ten participants to be recruited from EDSS 4 to 5.5
• • Ten participants to be recruited from EDSS 5.5 to 6.5
• • Within the anthropometric requirements of the REX device (See 'RAPPER III- MS 014 TF-04 v 3.0 REX Clinical Assessment Guide A4' for details of weight, height, size and range of motion requirements)
• • Offer written informed consent to take part in the study
• Exclusion Criteria:
• • a history of osteoporosis or osteoporosis related bone fractures.
• • skin integrity issues that could be adversely affected by the REX device
• • severe hypertonia (spasticity) as indicated by a score equal to or greater than 4 on the modified Ashworth scale for any muscle in their lower limbs.
• • a behavioural, cognitive or communication impairment which could interfere with the ability to participate in a rehabilitation program, as noted during screening (e.g., agitation, inability to follow two step commands)
• • are unable or unwilling to provide informed consent
• • are considered medically unsuitable for rehabilitation in the opinion of the screening medical specialist
• • a known allergy (skin contact) to materials used in Rex
• • are pregnant
• • taking part in any other medical research trial at the same time