Clinical trial NCT06429085: Rex Robot Assisted Rehabilitation to Enhance Balance and Mobility for People With Multiple Sclerosis, Clinical and Biomarker Study - RAPPER IV
Official title: Rex Robot Assisted Rehabilitation to Enhance Balance and Mobility for People With Multiple Sclerosis, Clinical and Biomarker Study - RAPPER IV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Sclerosis
Keywords: Balance
Core stability
Mobility
Powered exoskeleton
Neuro-rehabilitation
Lead sponsor: East Kent Hospitals University NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: Rex Bionics
First posted: 2024-05-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, open label, single arm, non-randomized, non-comparative feasibility study of Rex robot assisted training to improve balance and mobility for people living with MS.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

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

Primary outcomes:
measure: Timed transfer into the Rex device
timeFrame: Time point 1 - Week 1
measure: Completion of sit to stand and stand to sit within the Rex device
timeFrame: Time point 1 - Week 1
measure: Completion of 1 Rex robotic assisted balance rehabilitation exercise session
timeFrame: Time point 1 - Week 1
measure: Screening loss analysis
timeFrame: End of recruitment period - Week 30
Secondary outcomes:
measure: Timed up and Go
timeFrame: Time point 1 - Week 1
measure: Berg Balance Scale
timeFrame: Measured at 3 time points: Weeks 1, 6 and 10
measure: Visual Analog Scale (Pain)
timeFrame: Measured at 2 time points: Weeks 1 and 6
measure: Modified Falls Efficacy Scale
timeFrame: Measured at 2 time points: Weeks 1 and 6
measure: Activities-specific Balance Confidence scale
timeFrame: Measured at 2 time points: Weeks 1 and 6
measure: Spasticity Impact Scale
timeFrame: Measured at 2 time points: Weeks 1 and 6
measure: EQ-5D-5L
timeFrame: Measured at 2 time points: Weeks 1 and 6
measure: MSIS-29
timeFrame: Measured at 2 time points: Weeks 1 and 6
measure: Joint range of movement
timeFrame: Measured at 2 time points: Weeks 1 and 6
measure: Goal Attainment Scale
timeFrame: Set at Week 1 and measured and reviewed at Week 25
measure: Modified Ashworth Scale
timeFrame: Measured at 2 time points: Weeks 1 and 6
Other outcomes:
Locations:
city: Canterbury
country: United Kingdom
facility: East Kent Hospitals University NHS Trust
state: Kent
Study officials:
References:
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