Robotics for Mobility Rehabilitation in MS
Rex Robot Assisted Rehabilitation Exercise to Enhance Balance, Mobility and Upper Limb Function in People With Multiple Sclerosis
What it found
We found no results in the registry or in papers.
This trial finished 9 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Balance exercise program using exoskeleton device
What it measured
Main measures
Completion and time taken for participant transfer into Rex device
First trial session
Completion of sit to stand in Rex device by participant
First trial session
VisionCompletion of 1 timed 3 metre walk in device (Timed Up & Go Test)
First trial session
Walking and mobilityCompletion of trial sessions
6 sessions in total
Who could take part
MS (type not specified) · 18 to 90 · EDSS 6 to 7.5
Show the full criteria
Inclusion criteria
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
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 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
History
Started
Mar 2017
Main results due
Sept 2017
Finished
Sept 2017