Status:
RECRUITING
Acceptability of Exoskeleton Assisted Walking for Persons With Mobility Issues Due to Multiple Sclerosis
Lead Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Conditions:
Multiple Sclerosis
Pathologic Processes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 suc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04786821
Start Date
June 23 2022
End Date
October 30 2024
Last Update
May 29 2024
Active Locations (1)
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1
sheffield teching hospital NHS foundation trust
Sheffield, South Yorkshire, United Kingdom, S10 2JF