Multiple SclerosisExoMSNCT04786821
Acceptability of Exoskeleton Assisted Walking for Persons With Mobility Issues Due to Multiple Sclerosis
A study testing Standard Exercise Training and Phoenix Exoskeleton suit in people with Multiple Sclerosis and Pathologic Processes, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Pathologic Processes, Sclerosis
- What is being tested?
- Standard Exercise Training and Phoenix Exoskeleton suit
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Jun 2022to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
sheffield teching hospital NHS foundation trust
Sheffield, South Yorkshire, S10 2JF
About this study
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
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
- Being tested
- Standard Exercise Training, Phoenix Exoskeleton suit
- Keywords
- Exoskeleton Device, Exercise Programme
- Medical subject headings
- Multiple Sclerosis, Pathologic Processes, Sclerosis, Autoimmune Diseases of the Nervous System, Demyelinating Autoimmune Diseases, CNS, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Exercise TrainingBehavioural
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.
Phoenix Exoskeleton suitDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Phoenix Exoskeleton suit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (10)
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start23 Jun 2022
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Krishnan Padmakumari Sivaraman Nair, Principal investigator, Sheffield Teaching Hospitals NHS Foundation TrustAnouska Carter, Study chair, Sheffield Hallam UniversityChristine Smith, Study director, Sheffield Hallam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786821
- Sponsor's protocol ID
- STH20833
- Acronym
- ExoMS
- Status last verified
- May 2026
- First submitted
- 18 Jan 2021
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04786821
- Acronym / sponsor ID
- ExoMS / STH20833
- Conditions
- Multiple Sclerosis, Pathologic Processes, Sclerosis, Autoimmune Diseases of the Nervous System, Demyelinating Autoimmune Diseases, CNS, Autoimmune Diseases
- Keywords
- Exoskeleton Device, Exercise Programme
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard Exercise Training Programme | Placebo comparator | Behavioral: Standard Exercise TrainingParticipants will receive interventions by an exercise specialist based on the participant's tolerance. These sessions will be delivered by a exercise specialist. |
| Exoskeleton Exercise Programme | Active comparator | Device: Phoenix Exoskeleton suitThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Exercise TrainingParticipants 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. | Behavioural | Standard Exercise Training Programme |
| Phoenix Exoskeleton suitParticipants 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. | Device | Exoskeleton Exercise Programme |
Primary outcome
Recruitment rate estimation
Time frame: One day
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
Time frame: 8 weeks
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
Time frame: 8 weeks
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
Time frame: 8 weeks
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.
10 secondary outcomes
Number of participants achieving target heart rate
Time frame: 8 weeks
Aerobic Fitness (arm cranking)
Time frame: 8 weeks
Waist to hip ratio
Time frame: 8 weeks
Body fat percentages
Time frame: 8 weeks
10 metre walking gait test wearing inertial sensors
Time frame: 8 weeks
Multiple Sclerosis Impact Scale (MSIS-29)
Time frame: 8 weeks
Modified Fatigue Impact Scale (MFIS)
Time frame: 8 weeks
Multiple Sclerosis walking scale (MSWS-12)
Time frame: 8 weeks
The Borg rating of perceived exertion scale
Time frame: 8 weeks
Quality of life questionnaire (EQ-5D-5L & VAS)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krishnan Padmakumari Sivaraman Nair principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
Anouska Carter study chair
Sheffield Hallam University
Christine Smith study director
Sheffield Hallam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Exercise Training and Phoenix Exoskeleton suit in people with Multiple Sclerosis and Pathologic Processes, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate estimation (time frame: One day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.