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Sponsor: East Kent Hospitals University NHS Foundation Trust
Conditions: Multiple Sclerosis
Interventions: Rex robotic assisted balance exercises
Countries: United Kingdom
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.
Sex: ALL
Age: 18 Years to 79 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Canterbury, Kent, United Kingdom