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

NCT06429085 | Completed Phase 1

• 1 other identifier: Protocol Version 2.0
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Balance; Core stability; Mobility; Powered exoskeleton; Neuro-rehabilitation

Outcome Measures

Primary Outcomes (4)

• Timed transfer into the Rex device

  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

  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

  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

  Number of individuals screened and those eligible who entered the trial and those who completed the trial

  End of recruitment period - Week 30

Secondary Outcomes (11)

• Timed up and Go

  Time point 1 - Week 1

• Berg Balance Scale

  Measured at 3 time points: Weeks 1, 6 and 10

• Visual Analog Scale (Pain)

  Measured at 2 time points: Weeks 1 and 6

• Modified Falls Efficacy Scale

  Measured at 2 time points: Weeks 1 and 6

• Activities-specific Balance Confidence scale

  Measured at 2 time points: Weeks 1 and 6

Study Arms (1)

People diagnosed with Multiple Sclerosis

EXPERIMENTAL

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

Device: Rex robotic assisted balance exercises

Interventions

Rex robotic assisted balance exercises DEVICE

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.

People diagnosed with Multiple Sclerosis

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• East Kent Hospitals University NHS Foundation Trust: lead
• Rex Bionics: collaborator

Study Sites (1)

East Kent Hospitals University NHS Trust

Canterbury, Kent, United Kingdom

Location

Related Publications (10)

• 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. 2003 Nov 8;362(9395):1517-26. doi: 10.1016/S0140-6736(03)14738-1.

  PMID: 14615106 RESULT

• 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: 10.1177/1352458515620933. Epub 2015 Dec 10.

  PMID: 26658817 RESULT

• 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.

  PMID: 24453699 RESULT

• 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 guideline development. Arch Phys Med Rehabil. 2013 Sep;94(9):1800-1828.e3. doi: 10.1016/j.apmr.2013.04.020. Epub 2013 May 10.

  PMID: 23669008 RESULT

• 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.

  PMID: 25746432 RESULT

• 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: 10.1136/jnnp.70.2.174.

  PMID: 11160464 RESULT

• 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.

  PMID: 17875557 RESULT

• 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 Neuroeng Rehabil. 2017 Jun 19;14(1):60. doi: 10.1186/s12984-017-0274-6.

  PMID: 28629390 RESULT

• 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.

  PMID: 6685237 RESULT

• 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. 2022 Dec 9;54:jrm00357. doi: 10.2340/jrm.v54.4544.

  PMID: 36484722 RESULT

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 24, 2024
• Study Start: December 18, 2018
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)