Clinical trial NCT04786821: Acceptability of Exoskeleton Assisted Walking for Persons With Mobility Issues Due to Multiple Sclerosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Pathologic Processes
Sclerosis
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases
Keywords: Exoskeleton Device
Exercise Programme
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The eligible participants will be allocated to either arm using an online randomisation site in 1:1 randomisation ratio. All participants will have equal chance of getting allocated to either arm.
Primary purpose: SUPPORTIVE_CARE

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 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.


Eligibility 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.

Primary outcomes:
measure: Recruitment rate estimation
timeFrame: One day
measure: Retention rate estimation
timeFrame: 8 weeks
measure: Acceptability of the intervention - VAS
timeFrame: 8 weeks
measure: Acceptability of the intervention - Patient perception questionnaire
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of participants achieving target heart rate
timeFrame: 8 weeks
measure: Aerobic Fitness (arm cranking)
timeFrame: 8 weeks
measure: Waist to hip ratio
timeFrame: 8 weeks
measure: Body fat percentages
timeFrame: 8 weeks
measure: 10 metre walking gait test wearing inertial sensors
timeFrame: 8 weeks
measure: Multiple Sclerosis Impact Scale (MSIS-29)
timeFrame: 8 weeks
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: 8 weeks
measure: Multiple Sclerosis walking scale (MSWS-12)
timeFrame: 8 weeks
measure: The Borg rating of perceived exertion scale
timeFrame: 8 weeks
measure: Quality of life questionnaire (EQ-5D-5L & VAS)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: sheffield teching hospital NHS foundation trust
state: South Yorkshire
Study officials:
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
name: Krishnan Padmakumari Sivaraman Nair
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheffield Hallam University
name: Anouska Carter
role: STUDY_CHAIR
affiliation: Sheffield Hallam University
name: Christine Smith
role: STUDY_DIRECTOR
References: