RAPPER IV
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Rex robotic assisted balance exercises
What it measured
Main measures
Timed transfer into the Rex device
Time point 1 - Week 1
Completion of sit to stand and stand to sit within the Rex device
Time point 1 - Week 1
Completion of 1 Rex robotic assisted balance rehabilitation exercise session
Time point 1 - Week 1
Walking and mobilityPhysical functionScreening loss analysis
End of recruitment period - Week 30
Other measures (11)
Timed up and Go
Time point 1 - Week 1
Walking and mobilityBerg Balance Scale
Measured at 3 time points: Weeks 1, 6 and 10
Walking and mobilityVisual Analog Scale (Pain)
Measured at 2 time points: Weeks 1 and 6
PainModified Falls Efficacy Scale
Measured at 2 time points: Weeks 1 and 6
Walking and mobilityActivities-specific Balance Confidence scale
Measured at 2 time points: Weeks 1 and 6
Walking and mobilitySpasticity Impact Scale
Measured at 2 time points: Weeks 1 and 6
SpasticityEQ-5D-5L
Measured at 2 time points: Weeks 1 and 6
Quality of life (reported by participants)MSIS-29
Measured at 2 time points: Weeks 1 and 6
Quality of life (reported by participants)Joint range of movement
Measured at 2 time points: Weeks 1 and 6
Goal Attainment Scale
Set at Week 1 and measured and reviewed at Week 25
Who could take part
MS (type not specified) · 18 to 79
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Zajicek J, Fox P, Sanders H, Wright D, Vickery J, Nunn A, Thompson A; UK MS Research Group. Cannabinoids for treatment of spasticity and other symptoms related to multiple sclerosis (CAMS study): multicentre randomised placebo-controlled trial. Lancet. 2003 Nov 8;362(9395):1517-26. doi: 10.1016/S0140-6736(03)14738-1.Results
Straudi S, Fanciullacci C, Martinuzzi C, Pavarelli C, Rossi B, Chisari C, Basaglia N. The effects of robot-assisted gait training in progressive multiple sclerosis: A randomized controlled trial. Mult Scler. 2016 Mar;22(3):373-84. doi: 10.1177/1352458515620933. Epub 2015 Dec 10.Results
Bethoux F, Bennett S. Introduction: enhancing mobility in multiple sclerosis. Int J MS Care. 2011 Spring;13(1):1-3. doi: 10.7224/1537-2073-13.1.1. No abstract available.Results
Latimer-Cheung AE, Pilutti LA, Hicks AL, Martin Ginis KA, Fenuta AM, MacKibbon KA, Motl RW. Effects of exercise training on fitness, mobility, fatigue, and health-related quality of life among adults with multiple sclerosis: a systematic review to inform guideline development. Arch Phys Med Rehabil. 2013 Sep;94(9):1800-1828.e3. doi: 10.1016/j.apmr.2013.04.020. Epub 2013 May 10.Results
Donze C. Update on rehabilitation in multiple sclerosis. Presse Med. 2015 Apr;44(4 Pt 2):e169-76. doi: 10.1016/j.lpm.2014.10.019. Epub 2015 Mar 4.Results
Wiles CM, Newcombe RG, Fuller KJ, Shaw S, Furnival-Doran J, Pickersgill TP, Morgan A. Controlled randomised crossover trial of the effects of physiotherapy on mobility in chronic multiple sclerosis. J Neurol Neurosurg Psychiatry. 2001 Feb;70(2):174-9. doi: 10.1136/jnnp.70.2.174.Results
Cattaneo D, Jonsdottir J, Zocchi M, Regola A. Effects of balance exercises on people with multiple sclerosis: a pilot study. Clin Rehabil. 2007 Sep;21(9):771-81. doi: 10.1177/0269215507077602.Results
Birch N, Graham J, Priestley T, Heywood C, Sakel M, Gall A, Nunn A, Signal N. Results of the first interim analysis of the RAPPER II trial in patients with spinal cord injury: ambulation and functional exercise programs in the REX powered walking aid. J Neuroeng Rehabil. 2017 Jun 19;14(1):60. doi: 10.1186/s12984-017-0274-6.Results
Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.Results
Sakel M, Saunders K, Hodgson P, Stephensen D, Phadke CP, Bassett PA, Wilkinson D. Feasibility and Safety of a Powered Exoskeleton for Balance Training for People Living with Multiple Sclerosis: A Single-Group Preliminary Study (Rapper III). J Rehabil Med. 2022 Dec 9;54:jrm00357. doi: 10.2340/jrm.v54.4544.
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History
Started
Dec 2018
Main results due
Mar 2020
Finished
Mar 2020
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