Acceptability of Exoskeleton Assisted Walking for Persons With Mobilit
Feasibility Study for a Randomised Control Trial for the Acceptability of Exoskeleton Assisted Walking Compared to Standard Exercise Training for Persons With Mobility Issues Due to Multiple Sclerosis
We could not find results for this trial
What it found
We found no results in the registry or in papers.
This trial finished 2 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Phoenix Exoskeleton suit
Placebo
- Standard Exercise Training
What it measured
Main measures
Recruitment rate estimation
One day
FeasibilityRetention rate estimation
8 weeks
Physical functionQuality of life (reported by participants)FeasibilityAcceptability of the intervention - VAS
8 weeks
SafetyFeasibilityAcceptability of the intervention - Patient perception questionnaire
8 weeks
Physical functionFeasibility
Other measures (10)
Number of participants achieving target heart rate
8 weeks
Walking and mobilityPhysical functionAerobic Fitness (arm cranking)
8 weeks
Walking and mobilityPhysical functionWaist to hip ratio
8 weeks
Body fat percentages
8 weeks
Physical function10 metre walking gait test wearing inertial sensors
8 weeks
Walking and mobilityPhysical functionMultiple Sclerosis Impact Scale (MSIS-29)
8 weeks
Physical functionQuality of life (reported by participants)Modified Fatigue Impact Scale (MFIS)
8 weeks
FatiguePhysical functionQuality of life (reported by participants)Multiple Sclerosis walking scale (MSWS-12)
8 weeks
Walking and mobilityPhysical functionQuality of life (reported by participants)The Borg rating of perceived exertion scale
8 weeks
Walking and mobilityPhysical functionQuality of life questionnaire (EQ-5D-5L & VAS)
8 weeks
Physical functionQuality of life (reported by participants)
Who could take part
MS (type not specified) · 18 and over · EDSS 5.0 to 7.5
Show the full criteria
Inclusion criteria
* Diagnosis of MS as per the McDonald criteria (Polman et al., 2011). * Age 18 years or older. * Cognitive ability to give consent and participate in the protocol. * Walking limitations with Expanded Disability Status Scale (EDSS) scores ranging from 5.0 to 7.5. * Enough strength in hands and shoulders to support themselves standing and walking using crutches or a walker. * Meet the general requirements to fit with the Phoenix Exoskeleton (160-190.5 cm in height, weight below 80 Kg, hip width no greater than 42.7 cm measured when sitting, healthy skin where it touches Phoenix Exoskeleton). * Able to tolerate exercise twice per week as judged by the PI during screening.
Exclusion criteria
* Any illness, other than MS, affecting walking and exercise performance. * Severe cognitive or behavioral impairment. * Relapses 3 months prior to enrolment. * Change in disease modifying drugs for MS 6 months before enrolment. * Botulin toxin injections for the lower limbs the previous 3 months. * Any medical contraindications to assisted walking (e.g., cardiovascular condition, weight-bearing restrictions, osteoporosis or other fracture risk, pregnancy, uncontrolled seizure). * Significant flexion contractures limited to 35 degrees at the hip and 20 degrees at the knee that precluded Phoenix Exoskeleton fit. * Psychopathology or other health conditions that the physiotherapist, in his or her clinical judgement, considers to be exclusionary to safely use an Exoskeleton. * Living more than 20 miles away from the experiment location to reduce burden on patients due to the number of planned study visits.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Multiple sclerosis (MS) is a chronic, inflammatory disease of the central nervous system. Lack of physical activity is common in people with MS (pwMS). This can lead to several comorbid conditions such as obesity, metabolic syndrome, osteoporosis, hypertension, diabetes and worse prognosis. An increasing number of studies suggest that physical exercise can play an important role in managing symptoms, preventing complications and comorbidities in pwMS, and may possibly be neuroprotective. However, doing exercise can be very challenging for pwMS who have moderate/severe mobility disability and who have problems with walking. In this project, the investigators will explore the use of a powered Exoskeleton as an exercise tool for people with moderate to severe difficulty walking due to MS. Powered Exoskeletons are wearable robots that offer opportunity to persons with lower limb weakness to stand and walk. The Exoskeleton-assisted training provides active training with potentially much less intervention needed from therapists. However, it is not clear whether pwMS can walk with a powered Exoskeleton at speeds and intensities sufficient to positively affect health and fitness outcomes. Thus, in this study, the investigators aim to explore whether using an Exoskeleton will enable people with MS to exercise at a moderate intensity and whether people with MS find this acceptable and safe to do on a regular basis. The investigators will also explore whether training with an Exoskeleton can improve walking. The investigators will train 12 patients with MS to walk with an Exoskeleton twice a week for 8 weeks. The investigators will compare the effects with another group of 12 patients who will do exercises with a fitness instructor twice a week for 8 weeks. The investigators will study whether walking with Exoskeleton is better than fitness training in terms of fitness outcomes, walking and cognitive, psychological factors.
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History
- Result signal changed from Finished, results not yet expected to Finished, no results found
Started
Jun 2022
Main results due
Oct 2024
Finished
Oct 2024