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

Multiple Sclerosis Clinical Trial

— RAPPER IV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06429085
• Other study ID #: Protocol Version 2.0
• Status: Completed
• Phase: Phase 1
• Start date: December 18, 2018
• Est. completion date: March 31, 2020

Study information

• Verified date: May 2024
• Source: East Kent Hospitals University NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	East Kent Hospitals University NHS Trust	Canterbury	Kent

Sponsors (2)

Lead Sponsor	Collaborator
East Kent Hospitals University NHS Foundation Trust	Rex Bionics

Country where clinical trial is conducted

United Kingdom, 

References & Publications (10)

Bethoux F, Bennett S. Introduction: enhancing mobility in multiple sclerosis. Int J MS Care. 2011 Spring;13(1):1-3. doi: 10.7224/1537-2073-13.1.1. No abstract available. — View Citation

Birch N, Graham J, Priestley T, Heywood C, Sakel M, Gall A, Nunn A, Signal N. Results of the first interim analysis of the RAPPER II trial in patients with spinal cord injury: ambulation and functional exercise programs in the REX powered walking aid. J N — View Citation

Cattaneo D, Jonsdottir J, Zocchi M, Regola A. Effects of balance exercises on people with multiple sclerosis: a pilot study. Clin Rehabil. 2007 Sep;21(9):771-81. doi: 10.1177/0269215507077602. — View Citation

Donze C. Update on rehabilitation in multiple sclerosis. Presse Med. 2015 Apr;44(4 Pt 2):e169-76. doi: 10.1016/j.lpm.2014.10.019. Epub 2015 Mar 4. — View Citation

Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444. — View Citation

Latimer-Cheung AE, Pilutti LA, Hicks AL, Martin Ginis KA, Fenuta AM, MacKibbon KA, Motl RW. Effects of exercise training on fitness, mobility, fatigue, and health-related quality of life among adults with multiple sclerosis: a systematic review to inform — View Citation

Sakel M, Saunders K, Hodgson P, Stephensen D, Phadke CP, Bassett PA, Wilkinson D. Feasibility and Safety of a Powered Exoskeleton for Balance Training for People Living with Multiple Sclerosis: A Single-Group Preliminary Study (Rapper III). J Rehabil Med. — View Citation

Straudi S, Fanciullacci C, Martinuzzi C, Pavarelli C, Rossi B, Chisari C, Basaglia N. The effects of robot-assisted gait training in progressive multiple sclerosis: A randomized controlled trial. Mult Scler. 2016 Mar;22(3):373-84. doi: 10.1177/13524585156 — View Citation

Wiles CM, Newcombe RG, Fuller KJ, Shaw S, Furnival-Doran J, Pickersgill TP, Morgan A. Controlled randomised crossover trial of the effects of physiotherapy on mobility in chronic multiple sclerosis. J Neurol Neurosurg Psychiatry. 2001 Feb;70(2):174-9. doi — View Citation

Zajicek J, Fox P, Sanders H, Wright D, Vickery J, Nunn A, Thompson A; UK MS Research Group. Cannabinoids for treatment of spasticity and other symptoms related to multiple sclerosis (CAMS study): multicentre randomised placebo-controlled trial. Lancet. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed transfer into the Rex device	Timed transfer into the Rex device with appropriate level of assistance	Time point 1 - Week 1
Primary	Completion of sit to stand and stand to sit within the Rex device	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
Primary	Completion of 1 Rex robotic assisted balance rehabilitation exercise session	Completion of 1 Rex robotic assisted balance rehabilitation exercise session with hands on assistance from trial therapist	Time point 1 - Week 1
Primary	Screening loss analysis	Number of individuals screened and those eligible who entered the trial and those who completed the trial	End of recruitment period - Week 30
Secondary	Timed up and Go	Timed up and Go	Time point 1 - Week 1
Secondary	Berg Balance Scale	Berg Balance Scale	Measured at 3 time points: Weeks 1, 6 and 10
Secondary	Visual Analog Scale (Pain)	Visual Analog Scale (Pain)	Measured at 2 time points: Weeks 1 and 6
Secondary	Modified Falls Efficacy Scale	Balance and falls risk	Measured at 2 time points: Weeks 1 and 6
Secondary	Activities-specific Balance Confidence scale	Balance and confidence in balance	Measured at 2 time points: Weeks 1 and 6
Secondary	Spasticity Impact Scale	Perception of impact of spasticity on life	Measured at 2 time points: Weeks 1 and 6
Secondary	EQ-5D-5L	Perceived Health Related Quality of Life	Measured at 2 time points: Weeks 1 and 6
Secondary	MSIS-29	Perceived impact of MS on life	Measured at 2 time points: Weeks 1 and 6
Secondary	Joint range of movement	Joint range of movement	Measured at 2 time points: Weeks 1 and 6
Secondary	Goal Attainment Scale	Goal Attainment Scale	Set at Week 1 and measured and reviewed at Week 25
Secondary	Modified Ashworth Scale	Modified Ashworth Scale for muscle spasticity	Measured at 2 time points: Weeks 1 and 6