Multiple Sclerosis
Conditions
Keywords
Balance, Core stability, Mobility, Powered exoskeleton, Neuro-rehabilitation
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.
Detailed description
The key research questions: * Is it feasible for a person with balance and mobility impairment caused by MS to use a robotic walking device to exercise in standing and walking with supervision safely? * What are the key outcome measures most sensitive to measurable change in this study population sample, which may reflect potential improvement during the trial period? (Clinical outcome scales and self-reported questionnaires) * Is this robotic assisted balance and mobility training program feasible, safe and effective? * Does the completion of this balance and mobility exercise treatment intervention result in measurable improvements in balance, mobility, spasticity, lower limb joint range of movement and achievable individual patient goals? To answer these questions, we invited 20 people diagnosed with MS (as defined by McDonald criteria, Polman et al, 2011) to undertake a 5-week balance exercise intervention program supported by the use of the Rex robotic walking device, designed to strengthen their postural body and leg muscles and improve their balance. Participants were monitored and progressed on an individual basis throughout the treatment program as appropriate and a range of standardised assessments, questionnaires and relevant clinical outcome scales were used to capture and measure change related to this trial. Prospective, open label, single arm, non-randomized, non-comparative feasibility study of Rex robot assisted training to improve balance, mobility and cardiovascular fitness for people living with MS. A purposive sample of 20 adults, who have a primary diagnosis of MS, aged between 18 and 80 years old, with an Expanded Disability Status Scale (EDSS) as defined by Kurtzke (1983), with scores between 4 and 6.5 were recruited into this study.
Interventions
DEVICERex robotic assisted balance exercises
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.
Sponsors
Rex Bionics
East Kent Hospitals University NHS Foundation Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timed transfer into the Rex device | Time point 1 - Week 1 | Timed transfer into the Rex device with appropriate level of assistance |
| Completion of sit to stand and stand to sit within the Rex device | Time point 1 - Week 1 | Completion of sit to stand and stand to sit within the Rex device with hands on assistance from trial therapist |
| Completion of 1 Rex robotic assisted balance rehabilitation exercise session | Time point 1 - Week 1 | Completion of 1 Rex robotic assisted balance rehabilitation exercise session with hands on assistance from trial therapist |
| Screening loss analysis | End of recruitment period - Week 30 | Number of individuals screened and those eligible who entered the trial and those who completed the trial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Activities-specific Balance Confidence scale | Measured at 2 time points: Weeks 1 and 6 | Balance and confidence in balance |
| Spasticity Impact Scale | Measured at 2 time points: Weeks 1 and 6 | Perception of impact of spasticity on life |
| EQ-5D-5L | Measured at 2 time points: Weeks 1 and 6 | Perceived Health Related Quality of Life |
| Timed up and Go | Time point 1 - Week 1 | Timed up and Go |
| Joint range of movement | Measured at 2 time points: Weeks 1 and 6 | Joint range of movement |
| Goal Attainment Scale | Set at Week 1 and measured and reviewed at Week 25 | Goal Attainment Scale |
| Modified Ashworth Scale | Measured at 2 time points: Weeks 1 and 6 | Modified Ashworth Scale for muscle spasticity |
| MSIS-29 | Measured at 2 time points: Weeks 1 and 6 | Perceived impact of MS on life |
| Berg Balance Scale | Measured at 3 time points: Weeks 1, 6 and 10 | Berg Balance Scale |
| Visual Analog Scale (Pain) | Measured at 2 time points: Weeks 1 and 6 | Visual Analog Scale (Pain) |
| Modified Falls Efficacy Scale | Measured at 2 time points: Weeks 1 and 6 | Balance and falls risk |
Countries
United Kingdom
Outcome results
None listed