Acceptability of Exoskeleton Assisted Walking for Persons With Mobility Issues Due to Multiple Sclerosis (ExoMS)
Primary Purpose
Multiple Sclerosis, Pathologic Processes, Sclerosis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Standard Exercise Training
Phoenix Exoskeleton suit
Sponsored by
About this trial
This is an interventional supportive care trial for Multiple Sclerosis focused on measuring Exoskeleton Device, Exercise Programme
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Standard Exercise Training Programme
Exoskeleton Exercise Programme
Arm Description
Participants will receive interventions by an exercise specialist based on the participant's tolerance. These sessions will be delivered by a exercise specialist.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Number of participants achieving target heart rate
Heart rate will be monitored throughout the intervention sessions. This will be used to explore the level of exercise stimulation achieved through powered exoskeleton walking compared to exercise training.
Aerobic Fitness (arm cranking)
To be completed at baseline and follow up. This will be used to explore the level of exercise stimulation achieved through powered exoskeleton walking compared to exercise training.
Waist to hip ratio
Waist to hip ratio measurement is calculated by dividing the measurement of the waist by the hip measurement. To be completed at baseline and follow up.
Body fat percentages
Body fat percentage, measures a person's relative body composition without regard to height or weight. To be completed at baseline and follow up.
10 metre walking gait test wearing inertial sensors
This will only be completed in participants that are able to walk minimum of 2 metres with or without assistance. To be completed at baseline and follow up. To assess the effect of Exoskeleton and exercise training on gait.
Multiple Sclerosis Impact Scale (MSIS-29)
Multiple Sclerosis Impact Scale (MSIS-29) used to capture views about the impact of MS on participants day-to-day life during the past two weeks. To be completed at baseline and follow up to assess the impact of Exoskeleton and exercise training on MS related symptoms and quality of life. MSIS-29 provides a score between 29-145 where larger scores indicate that MS has a greater impact on day-to-day life for the participant.
Modified Fatigue Impact Scale (MFIS)
Modified Fatigue Impact Scale (MFIS) will be used to assess how fatigue impacts individuals lives in the past 4 weeks. To be completed at baseline and follow up to assess the impact of Exoskeleton and exercise training on MS related symptoms and quality of life.. Scores range between 0-84 where larger scores indicate greater impact of fatigue on daily life.
Multiple Sclerosis walking scale (MSWS-12)
Multiple Sclerosis walking scale (MSWS-12) used to capture a self-reported measure of the impact of MS on the individual's walking ability in the past 2 weeks. To be completed at baseline and follow up to assess the impact of Exoskeleton and exercise training on MS related symptoms and quality of life. Scores range between 12-60 where larger scores indicate greater impact of MS on walking activities.
The Borg rating of perceived exertion scale
Participant's will be asked to rate physical activity intensity level throughout the study. Borg RPE scale will be used, 6-20 where 6 = no effort at all and 20= absolute maximal effort. This will be used to explore the level of exercise stimulation achieved through powered Exoskeleton walking compared to exercise training.
Quality of life questionnaire (EQ-5D-5L & VAS)
EuroQol quality of life questionnaire (EQ-5D-5L) will be used to capture views about the participants quality of life within 24hours in 5 themes. Using the VAS scores, participants will rate their quality of life between 100 = the best health you can imagine and 0 = the worst health you can imagine. To be completed at baseline and follow up. This will be used to assess the impact of Exoskeleton and exercise training on quality of life.
Full Information
NCT ID
NCT04786821
First Posted
January 18, 2021
Last Updated
March 3, 2021
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT04786821
Brief Title
Acceptability of Exoskeleton Assisted Walking for Persons With Mobility Issues Due to Multiple Sclerosis
Acronym
ExoMS
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Pathologic Processes, Sclerosis, Autoimmune Diseases of the Nervous System, Demyelinating Autoimmune Diseases, CNS, Autoimmune Diseases
Keywords
Exoskeleton Device, Exercise Programme
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard Exercise Training Programme
Arm Type
Placebo Comparator
Arm Description
Participants will receive interventions by an exercise specialist based on the participant's tolerance. These sessions will be delivered by a exercise specialist.
Arm Title
Exoskeleton Exercise Programme
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Exercise Training
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Phoenix Exoskeleton suit
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment rate estimation
Description
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.
Time Frame
One day
Title
Retention rate estimation
Description
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.
Time Frame
8 weeks
Title
Acceptability of the intervention - VAS
Description
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.
Time Frame
8 weeks
Title
Acceptability of the intervention - Patient perception questionnaire
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Number of participants achieving target heart rate
Description
Heart rate will be monitored throughout the intervention sessions. This will be used to explore the level of exercise stimulation achieved through powered exoskeleton walking compared to exercise training.
Time Frame
8 weeks
Title
Aerobic Fitness (arm cranking)
Description
To be completed at baseline and follow up. This will be used to explore the level of exercise stimulation achieved through powered exoskeleton walking compared to exercise training.
Time Frame
8 weeks
Title
Waist to hip ratio
Description
Waist to hip ratio measurement is calculated by dividing the measurement of the waist by the hip measurement. To be completed at baseline and follow up.
Time Frame
8 weeks
Title
Body fat percentages
Description
Body fat percentage, measures a person's relative body composition without regard to height or weight. To be completed at baseline and follow up.
Time Frame
8 weeks
Title
10 metre walking gait test wearing inertial sensors
Description
This will only be completed in participants that are able to walk minimum of 2 metres with or without assistance. To be completed at baseline and follow up. To assess the effect of Exoskeleton and exercise training on gait.
Time Frame
8 weeks
Title
Multiple Sclerosis Impact Scale (MSIS-29)
Description
Multiple Sclerosis Impact Scale (MSIS-29) used to capture views about the impact of MS on participants day-to-day life during the past two weeks. To be completed at baseline and follow up to assess the impact of Exoskeleton and exercise training on MS related symptoms and quality of life. MSIS-29 provides a score between 29-145 where larger scores indicate that MS has a greater impact on day-to-day life for the participant.
Time Frame
8 weeks
Title
Modified Fatigue Impact Scale (MFIS)
Description
Modified Fatigue Impact Scale (MFIS) will be used to assess how fatigue impacts individuals lives in the past 4 weeks. To be completed at baseline and follow up to assess the impact of Exoskeleton and exercise training on MS related symptoms and quality of life.. Scores range between 0-84 where larger scores indicate greater impact of fatigue on daily life.
Time Frame
8 weeks
Title
Multiple Sclerosis walking scale (MSWS-12)
Description
Multiple Sclerosis walking scale (MSWS-12) used to capture a self-reported measure of the impact of MS on the individual's walking ability in the past 2 weeks. To be completed at baseline and follow up to assess the impact of Exoskeleton and exercise training on MS related symptoms and quality of life. Scores range between 12-60 where larger scores indicate greater impact of MS on walking activities.
Time Frame
8 weeks
Title
The Borg rating of perceived exertion scale
Description
Participant's will be asked to rate physical activity intensity level throughout the study. Borg RPE scale will be used, 6-20 where 6 = no effort at all and 20= absolute maximal effort. This will be used to explore the level of exercise stimulation achieved through powered Exoskeleton walking compared to exercise training.
Time Frame
8 weeks
Title
Quality of life questionnaire (EQ-5D-5L & VAS)
Description
EuroQol quality of life questionnaire (EQ-5D-5L) will be used to capture views about the participants quality of life within 24hours in 5 themes. Using the VAS scores, participants will rate their quality of life between 100 = the best health you can imagine and 0 = the worst health you can imagine. To be completed at baseline and follow up. This will be used to assess the impact of Exoskeleton and exercise training on quality of life.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Learn more about this trial
Acceptability of Exoskeleton Assisted Walking for Persons With Mobility Issues Due to Multiple Sclerosis
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