Robotics for Mobility Rehabilitation in MS

NCT05102682 | Completed Phase 1 DMC

• 1 other identifier: REC reference: 16/EE/0553
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Title Prospective, open label, single arm, non-randomized, non-comparative feasibility study of Rex robot assisted rehabilitation exercise to enhance balance, mobility and upper limb function in people with Multiple Sclerosis "RAPPER III - MS Objective The objective of this study is to evaluate the feasibility and safety of the REX Robot when used for rehabilitation with people who have moderate to severe mobility restrictions due to MS. A secondary objective of the study is to explore the acceptability of the device to people with MS and its impact on impairments and functions commonly affected by MS. Study Sponsor Rex Bionics, Plc. Study Device REX Robotic powered exercise system Primary Endpoint • Completion of a transfer, stand, balance and walk rehabilitation session.

• Unexpected Serious Adverse Events Secondary Endpoints
• Completion of a transfer, stand, balance and walk rehabilitation program over Six-weeks
• The Number of approached, screened, and eligible potential participants. Reasons for Ineligibility. (See 'RAPPER III- MS 007 Screening Loss Analysis REV 0 FINAL')
• Functional Ambulation Classification (FAC) 1
• Activities-specific Balance Confidence (ABC) Scale 2
• Modified Falls Efficacy Scale (MFES) 3, 4,
• Multiple Sclerosis Walking scale (MSWS-12) 5
• Multiple Sclerosis Impact scale (MSIS-29) 6
• ARMA (arm activity measure) 7
• Berg Balance Scale 8
• Timed unsupported steady stand (TUSS) 9
• Pain scale questionnaire (Visual Analog Score VAS) 10
• Modified Ashworth Score 11
• Spasticity Impact Scale 12
• Epworth Sleepiness Scale (ESS) questionnaire 13
• EQ-5D Health State Questionnaire 14 Questionnaires may be administered in person, by phone, email or in the post.

Conditions

Multiple Sclerosis; MS

Keywords

Neurorehabilitation; Feasibility; exoskeleton

Outcome Measures

Primary Outcomes (4)

• Completion and time taken for participant transfer into Rex device

  Timed transfer into device (seconds)

  First trial session

• Completion of sit to stand in Rex device by participant

  Participant inside Rex device with device switched on moves from sit to stand with supervision of therapist

  First trial session

• Completion of 1 timed 3 metre walk in device (Timed Up & Go Test)

  Participant completes timed walk as above with assistance and guidance from therapist

  First trial session

• Completion of trial sessions

  Completion of all 6 trial sessions noted and recorded in records

  6 sessions in total

Study Arms (1)

Balance rehabilitation exercise

EXPERIMENTAL

Balance rehabilitation exercise program using exoskeleton device

Other: Balance exercise program using exoskeleton device

Interventions

Balance exercise program using exoskeleton device OTHER

Exercise program focused on strengthening core body muscles and balance supported by Rex exoskeleton device

Balance rehabilitation exercise

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a confirmed diagnosis of MS by a Consultant Neurologist as per Mc Donald Criteria. Have moderate to severe mobility restriction as defined by an Extended Disability Status Scale (EDSS) score of between 6 to 7.5 (inclusive). Meet the anthropometric requirements of the REX device (See 'RAPPER IIIMS 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 on any muscle in their lower limbs. a behavioural, cognitive or communication impairment which could interfere with the ability to participate in a rehabilitation programme, 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

Sponsors & Collaborators

• East Kent Hospitals University NHS Foundation Trust: lead

Study Sites (1)

East Kent Hospitals University NHS Trust

Canterbury, Kent, United Kingdom

Location

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 Officials

• Mohamed Dr Sakel, MBBS

  East Kent Hospitals University NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Prospective, open label, single arm, non-randomized, non-comparative feasibility study.

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 1, 2021
• Study Start: March 10, 2017
• Primary Completion: September 12, 2017
• Study Completion: September 12, 2017
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)