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

May 20, 2024 updated by: East Kent Hospitals University NHS Foundation Trust

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Kent
      • Canterbury, Kent, United Kingdom
        • East Kent Hospitals University NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: People diagnosed with Multiple Sclerosis
Use of powered Rex robotic exoskeleton to enable the practice of core stability balance exercises
Device: Rex robotic assisted balance exercises
Individual is supported by a Rex robotic exoskeleton which enables assisted and supervised practise of balance exercises. This intervention took place as a supported and supervised series of 5 sessions over 5 weeks as an Out-patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed transfer into the Rex device
Time Frame: Time point 1 - Week 1
Timed transfer into the Rex device with appropriate level of assistance
Time point 1 - Week 1
Completion of sit to stand and stand to sit within the Rex device
Time Frame: Time point 1 - Week 1
Completion of sit to stand and stand to sit within the Rex device with hands on assistance from trial therapist
Time point 1 - Week 1
Completion of 1 Rex robotic assisted balance rehabilitation exercise session
Time Frame: Time point 1 - Week 1
Completion of 1 Rex robotic assisted balance rehabilitation exercise session with hands on assistance from trial therapist
Time point 1 - Week 1
Screening loss analysis
Time Frame: End of recruitment period - Week 30
Number of individuals screened and those eligible who entered the trial and those who completed the trial
End of recruitment period - Week 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed up and Go
Time Frame: Time point 1 - Week 1
Timed up and Go
Time point 1 - Week 1
Berg Balance Scale
Time Frame: Measured at 3 time points: Weeks 1, 6 and 10
Berg Balance Scale
Measured at 3 time points: Weeks 1, 6 and 10
Visual Analog Scale (Pain)
Time Frame: Measured at 2 time points: Weeks 1 and 6
Visual Analog Scale (Pain)
Measured at 2 time points: Weeks 1 and 6
Modified Falls Efficacy Scale
Time Frame: Measured at 2 time points: Weeks 1 and 6
Balance and falls risk
Measured at 2 time points: Weeks 1 and 6
Activities-specific Balance Confidence scale
Time Frame: Measured at 2 time points: Weeks 1 and 6
Balance and confidence in balance
Measured at 2 time points: Weeks 1 and 6
Spasticity Impact Scale
Time Frame: Measured at 2 time points: Weeks 1 and 6
Perception of impact of spasticity on life
Measured at 2 time points: Weeks 1 and 6
EQ-5D-5L
Time Frame: Measured at 2 time points: Weeks 1 and 6
Perceived Health Related Quality of Life
Measured at 2 time points: Weeks 1 and 6
MSIS-29
Time Frame: Measured at 2 time points: Weeks 1 and 6
Perceived impact of MS on life
Measured at 2 time points: Weeks 1 and 6
Joint range of movement
Time Frame: Measured at 2 time points: Weeks 1 and 6
Joint range of movement
Measured at 2 time points: Weeks 1 and 6
Goal Attainment Scale
Time Frame: Set at Week 1 and measured and reviewed at Week 25
Goal Attainment Scale
Set at Week 1 and measured and reviewed at Week 25
Modified Ashworth Scale
Time Frame: Measured at 2 time points: Weeks 1 and 6
Modified Ashworth Scale for muscle spasticity
Measured at 2 time points: Weeks 1 and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

East Kent Hospitals University NHS Foundation Trust

Collaborators

Rex Bionics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2018

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

May 13, 2024

First Submitted That Met QC Criteria

May 20, 2024

First Posted (Actual)

May 24, 2024

Study Record Updates

Last Update Posted (Actual)

May 24, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol Version 2.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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