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

East Kent Hospitals University NHS Foundation Trust

Status and phase: Completed; Phase 1

Conditions: Multiple Sclerosis

Treatments: Device: Rex robotic assisted balance exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT06429085

Protocol Version 2.0

Details and patient eligibility

About

Multiple Sclerosis (MS) poses challenges to balance and mobility, impacting the daily lives of affected individuals. The RAPPER IV study is a clinical trial to evaluate a balance and mobility training intervention supported by a powered Rex robotic exoskeleton for people living with MS.

Aims and objectives:

This study aims to gain an insight into the potential health benefits of using a Rex robot to assist in a neuro-rehabilitation intervention program focused on improving balance and functional mobility with supervision from a specialist clinician.

Objectives

• to evaluate the feasibility of using the Rex robotic walking device for rehabilitation with people who have mobility restrictions due to Multiple Sclerosis (MS)
• to assess and evaluate the clinical effectiveness of a 5-week robotic assisted exercise program focused on core stability exercises, balance and walking using patient related outcome measures
• to gain an insight into the experiences of participants and their spouses of using the robotic walking device for rehabilitation and how this has impacted on their lives

A single cohort group of 20 people who were living with MS who met trial eligibility criteria were recruited. A variety of clinical outcome measurements were taken pre, during and post trial and results were analysed by a statistician.

Full description

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 intervention result in measurable improvements in balance, mobility, spasticity, lower limb joint range of movement and achievable individual patient goals?

To answer these questions, we invited 20 people diagnosed with MS (as defined by "McDonald" criteria, Polman et al, 2011) to undertake a 5-week balance exercise intervention program supported by the use of the Rex robotic walking device, designed to strengthen their postural body and leg muscles and improve their balance.

Participants were monitored and progressed on an individual basis throughout the treatment program as appropriate and a range of standardised assessments, questionnaires and relevant clinical outcome scales were used to capture and measure change related to this trial.

Prospective, open label, single arm, non-randomized, non-comparative feasibility study of Rex robot assisted training to improve balance, mobility and cardiovascular fitness for people living with MS.

A purposive sample of 20 adults, who have a primary diagnosis of MS, aged between 18 and 80 years old, with an Expanded Disability Status Scale (EDSS) as defined by Kurtzke (1983), with scores between 4 and 6.5 were recruited into this study.

Enrollment: 20 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

People diagnosed with Multiple Sclerosis

Experimental group

Description:

Use of powered Rex robotic exoskeleton to enable the practice of core stability balance exercises

Treatment:

Device: Rex robotic assisted balance exercises