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Sponsor: East Kent Hospitals University NHS Foundation Trust
Conditions: Multiple Sclerosis, MS
Interventions: Balance exercise program using exoskeleton device
Countries: United Kingdom
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.
Sex: ALL
Age: 18 Years to 90 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Canterbury, Kent, United Kingdom