Acceptability of Exoskeleton Assisted Walking for Persons With Mobility Issues Due to Multiple Sclerosis

NCT04786821 | Recruiting

• 1 other identifier: STH20833
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Pathologic Processes; Sclerosis; Autoimmune Diseases of the Nervous System; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases

Keywords

Exoskeleton Device; Exercise Programme

Outcome Measures

Primary Outcomes (4)

• Recruitment rate estimation

  The research team will identify the number of potential participants who responded to our initial recruitment strategies and the proportion who remain interested after being informed of the requirements of the study. Feasibility will be classed as 60% or more of eligible participants consenting to the trial.

  One day

• Retention rate estimation

  Adherence will be measured through attendance at the Exoskeleton and exercise sessions and compliance to the protocol. Feasibility will be classed as 75% of the recruited participants completing 12 or more of the 16 intervention sessions (not including the familiarisation sessions). Patient Participation will be assessed by the research physiotherapist and exercise therapist using the Pittsburg Participation Questionnaire.

  8 weeks

• Acceptability of the intervention - VAS

  Data from participant's visual analogue scale of patient discomfort will be used to determine acceptability. Feasibility will be defined as less than 1/3 of participants reporting moderate or greater discomfort on the visual analogue scale. Throughout the study, participants asked to score discomfort experienced on VAS scale 0-10 where 0=no discomfort and 10=intolerable.

  8 weeks

• Acceptability of the intervention - Patient perception questionnaire

  A patient perception questionnaire will be used to gather more in-depth qualitative data about acceptability. This will give us insight into the acceptability of the type of exercise and any benefits that have been derived, helping us to take the project forward in the future and design an intervention that fits with the requirements of this population group.

  8 weeks

Secondary Outcomes (10)

• Number of participants achieving target heart rate

  8 weeks

• Aerobic Fitness (arm cranking)

  8 weeks

• Waist to hip ratio

  8 weeks

• Body fat percentages

  8 weeks

• 10 metre walking gait test wearing inertial sensors

  8 weeks

Study Arms (2)

Standard Exercise Training Programme

PLACEBO COMPARATOR

Participants will receive interventions by an exercise specialist based on the participant's tolerance. These sessions will be delivered by a exercise specialist.

Behavioral: Standard Exercise Training

Exoskeleton Exercise Programme

ACTIVE COMPARATOR

The Phoenix Exoskeleton suit will be used in this study. It is a powered Exoskeleton, with a modular design. Participants will receive interventions by an research physiotherapist based on the participant's tolerance.

Device: Phoenix Exoskeleton suit

Interventions

Standard Exercise Training BEHAVIORAL

Participants will receive interventions by an exercise specialist for up to 30 minutes based on the participant's tolerance. The exercises used in control group will depend on the individual and their abilities as evaluated in the baseline assessment session. Possible exercises include arm crank, recumbent cycle, and chair exercises. These sessions will be delivered by a member of the research team.

Standard Exercise Training Programme

Phoenix Exoskeleton suit DEVICE

Participants will aim to walk wearing the Exoskeleton for up to 30 minutes. Based on the participant's tolerance, the duration of walking can be shorter and can be split into shorter intervals to achieve more activity. Over the sessions, based on the participants' tolerance, gradually the duration of walking can be increased with shorter breaks. This will be delivered by a research physiotherapist.

Exoskeleton Exercise Programme

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Living more than 20 miles away from the experiment location to reduce burden on patients due to the number of planned study visits.

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

sheffield teching hospital NHS foundation trust

Sheffield, South Yorkshire, S10 2JF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Pathologic Processes; Sclerosis; Autoimmune Diseases of the Nervous System; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases; Demyelinating Diseases; Immune System Diseases; Pathological Conditions, Signs and Symptoms; Leukoencephalopathies; Brain Diseases; Central Nervous System Diseases

Study Officials

• Krishnan Padmakumari Sivaraman Nair

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Anouska Carter

  Sheffield Hallam University

  STUDY CHAIR

• Christine Smith

  Sheffield Hallam University

  STUDY DIRECTOR

Central Study Contacts

Krishnan Padmakumari Sivaraman Nair

CONTACT

44114271269; siva.nair@nhs.net

Emma Fargher

CONTACT

emma.fargher@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: It is not practical to blind the participants to the intervention as the study team are studying two different types of physical activities. The study team will explore whether it is feasible for the outcome assessor to be blind to the treatment allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: March 8, 2021
• Study Start: June 23, 2022
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

GB (1)