Multiple SclerosisNCT06921551
Exploratory Pilot Study on the Prolonged Use of the ABLE Exoskeleton in Multiple Sclerosis
A study testing ABLE Exoskeleton in people with Multiple Sclerosis, run by ABLE Human Motion S.L. at 1 site in Spain.
Trial summary
The goal of this study is to explore the potential clinical benefits of the ABLE Exoskeleton as part of a rehabilitation program in people with multiple sclerosis. The main question it aims to answer is: Can a rehabiliation program with the ABLE Exoskeleton help to mantain the physical and psychosocial health of… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- ABLE Exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSpain
- Study dates
- 7 Apr 2025to 29 May 2026
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 70 years old
- Diagnosed with multiple sclerosis
- Currently undergoing outpatient physical therapy treatment at the investigation site
- Ability to give informed consent
Who cannot join
- Significant osteoporosis that may increase the risk of fracture
- Unresolved fractures in the pelvis or extremities, or history of fragility fractures in the lower extremities in the last 2 years
- Spinal instability (or spinal orthoses, unless authorized by a physician)
- Severe spasticity: Level 4 on the Modified Ashworth Scale
- Orthostatic hypotension. Inability to tolerate a minimum of 30 minutes standing
- Uncontrolled autonomic dysreflexia
Show all 18Show fewer
- Medical instability
- Unstable cardiovascular system (CVS), hemodynamic instability, untreated hypertension (SBP>140, DBP>90 mmHg), unresolved deep venous thrombosis (DVT)
- Serious comorbidities, including any condition that a physician deems inappropriate for use of the ABLE Exoskeleton or to complete participation in the study
- Skin integrity problems on the contact surfaces of the device or that would prevent sitting
- Grade I or higher on EPUAP (European Pressure Ulcer Advisory Panel, 2019) on areas that will be in contact with the exoskeleton
- Colostomy
- Anthropometric measurements outside the values compatible with ABLE Exoskeleton. In particular, height not between 1.5-1.9 m, or weight over 100 kg
- Anatomical constraints (such as eg length differences, users unable to position themselves inside the device) that are incompatible with the device
- Restrictions in range of motion that prevent normal gait from being achieved or preventing the completion of a normal transition from sitting to standing or standing to sitting
- Heterotopic ossification
- Known pregnancy or breastfeeding
- Cognitive impairment that results in the inability to follow simple instructions, particularly psychological or cognitive problems that do not allow a participant to follow study procedures
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to explore the potential clinical benefits of the ABLE Exoskeleton as part of a rehabilitation program in people with multiple sclerosis. The main question it aims to answer is:
Can a rehabiliation program with the ABLE Exoskeleton help to mantain the physical and psychosocial health of people with multiple sclerosis?
Participants will:
- Have a gait training session of 60 min with the exoskeleton once a week for 12 months at the clinic
- Have an evaluation (tests and questionnaires) every 3 months at the clinic
- Conditions
- Multiple Sclerosis
- Being tested
- ABLE Exoskeleton
- Keywords
- Gait training, Wearable exoskeleton, Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABLE ExoskeletonDevice
Participants will undergo 60-min gait training sessions with the exoskeleton once a week for up to12 months
| Study group | Role | What they receive |
|---|---|---|
| Intervention with exoskeleton | Experimental | Participants will undergo 60-min gait training sessions with the exoskeleton as part of their rehabilitation program once a week for up to 12 months Receives: Device: ABLE Exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of therapeutic objectives achieved
Two therapeutic objectives per participant will be defined at baseline. At the end of the training program, it will be assessed if the objectives were accomplished or not.
Measured: From baseline to the end of the training program at 12 months
Lower extremity muscle strenght
The Daniels Muscle Testing scale will be used to measure the strength of muscles in the lower extremities at baseline, every 3 months and at the end of the gait training program to assess motor function after the training. Scores range from 0 (absence of muscle activity) to 5 (normal muscle activity)
Measured: Baseline, 3, 6, and 12 months post-training
Modified Ashworth Scale (MAS)
The Modified Ashworth Scale (MAS) measures spasticity in patients with lesions to the central nervous system. The scale assigns a grade of spasticity from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension). It will be evaluated at baseline, every 3 months and at the end of the gait training program without the device to assess the change in the spasticity after training
Measured: Baseline, 3, 6, and 12 months post-training
Location and level of pain
The location and level of pain using the numeric rating scale (NRS) will be assessed at baseline, every 3 months and at the end of the gait training program to assess the reduction of pain aftr the training
Measured: Baseline, 3, 6, and 12 months post-training
Timed 25-Feet Walk test (T25FW)
The Timed 25-Foot Walk (T25FW) test measures the time a person needs to walk 25 feet. This test will be assessed at baseline, every 3 months, and at the end of the gait training program without the device to assess the change in the walking function after the training
Measured: Baseline, 3, 6, and 12 months post-training
6-Minute Walk Test (6MWT)
The 6-Minute Walk Test (6MWT) measures the distance a person can walk in 6 minutes. This test will be assessed at baseline, every 3 months, and at the end of the gait training program without the device to assess the change in the walking function after the training
Measured: Baseline, 3, 6, and 12 months post-training
Borg Rating of Perceived Exertion
The Borg Rating of Perceived Exertion (RPE) scale is used to measure a person's perception of their effort and exertion, breathlessness, and fatigue during physical activity. Scores range from 6 (no exertion at all) to 20 (maximal exertion). It will be evaluated during the 6MWT at baseline, every 3 months, and after the end of the gait training program without the device to assess the change in the perceived exertion after the training
Measured: Baseline, 3, 6, and 12 months post-training
Trunk Impairment Scale (TIS)
The Trunk Impairment Scale (TIS) measures the motor impairment of the trunk through the evaluation of static and dynamic sitting balance as well as coordination of trunk movement. The total score ranges from 0 (minimal performance) to 23 (perfect performance). This test will be assessed at baseline, every 3 months, and at the end of the gait training program without the device to assess the change in the trunk impairment after training
Measured: Baseline, 3, 6, and 12 months post-training
Barthel Index (BI) score
The Barthel Index (BI) will be used to assess the participants' ability to perform mobility and self-care activities of daily living (ADL). The total score ranges from 0 (total dependency) to 100 (independency). It will be evaluated at baseline, every 3 months, and after the gait training program without the device to assess the change in the independence to perform ADL after the training
Measured: Baseline, 3, 6, and 12 months post-training
Modified Fatigue Impact Scale (MFIS) score
The Modified Fatigue Impact Scale (MFIS) provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning in persons with multiple sclerosis. The total score ranges from 0 to 84, with higher scores meaning a higher impact of fatigue. It will be evaluated iat baseline, every 3 months and at the end of the gait training program without the device to assess the change in the fatigue after the training
Measured: Baseline, 3, 6, and 12 months post-training
Multiple Sclerosis Quality of Life-54 (MSQoL-54) scores
The Multiple Sclerosis Quality of Life-54 (MSQoL-54) is a multidimensional health-related quality of life (QoL) measure that combines both generic and MS-specific items into a single instrument. There is no single overall score for the MSQoL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores. The higher the score, the best the outcome. It will be evaluated at baseline, every 3 months and at the end of the gait training program without the device to assess the change in the QoL after the training
Measured: Baseline, 3, 6, and 12 months post-training
Self-perceived impact on general health status
Participants' perceptions of the impact on their general health will be evaluated by the completion of a self-report questionnaire on the perceived impact on general health. This questionnaire has been designed by the researchers and intends to identify to what extent participants feel that the ABLE Exoskeleton contributed to a change in their health. The questionnaire covers 7 categories (cardiovascular system, musculoskeletal pain, neuropathic pain, bladder and bowel, spasticity, and sleep quality) using a 7-point Likert scale to assess the change.
Measured: 3, 6, and 12 months post-training
Level of motivation
Participants' perceptions on the level of motivation generated by the program with the ABLE Exoskeleton will be evaluated by the completion of a self-report questionnaire using a 7-point Likert scale. This questionnaire has been designed by the researchers.
Measured: After 12 months post-training
Psychosocial Impact of Assistive Devices Scale (PIADS) score
The Psychosocial Impact of Assistive Devices Scale (PIADS) is a 26-item, self-reported questionnaire that provides a measure of user perception and other psychological factors associated with assistive technology devices. Scores range from -78 (maximum negative impact) to +78 (maximum positive impact). It will be used to assess the effects of the ABLE Exoskeleton on functional independence, well-being, and quality of life of participants after the training program experience
Measured: After 12 months post-training
Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) score
The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) is a 12-item outcome measure that assesses user satisfaction with two components (Device and Services) using a 5-point scale ranging from 1 (not satisfied) to 5 (very satisfied). Only the 8 items referred to the device will be evaluated from participants and the whole 12 items from the therapists to measure user satisfaction with the ABLE Exoskeleton after the training program experience
Measured: After 12 months post-training
Secondary outcomes (3)
Time spent upright and time spent walking
In each gait training session, the time spent upright (in minutes) and the time spent walking (in minutes) with the device will be automatically measured and registered by the device
Measured: At session 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10
Number of steps walked
In each gait training session, the number of steps taken (step count) with the device will be automatically measured and registered by the device
Measured: At session 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10
Distance walked
In each gait training session, the distance walked (in meters) with the device will be automatically measured and registered by the device
Measured: At session 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start7 Apr 2025
- Primary completion29 May 2026
- Study completion29 May 2026
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- ABLE Human Motion S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fundación Esclerosis Múltiple Madrid (FEMM)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921551
- Sponsor's protocol ID
- ABLEexoMSpost
- Other IDs
- CIV-24-10-049336
- Status last verified
- Jun 2026
- First submitted
- 27 Mar 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Pilot Study on the Prolonged Use of the ABLE Exoskeleton in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06921551
- Acronym / sponsor ID
- ABLEexoMSpost
- Conditions
- Multiple Sclerosis
- Keywords
- Gait training, Wearable exoskeleton, Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- ABLE Human Motion S.L.Industry (pharma, biotech, devices)
- Collaborators
- Fundación Esclerosis Múltiple Madrid (FEMM)
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 29 May 2026 (actual)
- Study completion
- 29 May 2026 (actual)
- First posted
- 10 Apr 2025 (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.
The goal of this study is to explore the potential clinical benefits of the ABLE Exoskeleton as part of a rehabilitation program in people with multiple sclerosis. The main question it aims to answer is:
Can a rehabiliation program with the ABLE Exoskeleton help to mantain the physical and psychosocial health of people with multiple sclerosis?
Participants will:
- Have a gait training session of 60 min with the exoskeleton once a week for 12 months at the clinic
- Have an evaluation (tests and questionnaires) every 3 months at the clinic
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention with exoskeleton | Experimental | Device: ABLE ExoskeletonParticipants will undergo 60-min gait training sessions with the exoskeleton as part of their rehabilitation program once a week for up to 12 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 to 70 years old
- Diagnosed with multiple sclerosis
- Currently undergoing outpatient physical therapy treatment at the investigation site
- Ability to give informed consent
Key exclusion criteria (18 listed)
- Significant osteoporosis that may increase the risk of fracture
- Unresolved fractures in the pelvis or extremities, or history of fragility fractures in the lower extremities in the last 2 years
- Spinal instability (or spinal orthoses, unless authorized by a physician)
- Severe spasticity: Level 4 on the Modified Ashworth Scale
- Orthostatic hypotension. Inability to tolerate a minimum of 30 minutes standing
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 |
|---|---|---|
| ABLE ExoskeletonParticipants will undergo 60-min gait training sessions with the exoskeleton once a week for up to12 months | Device | Intervention with exoskeleton |
Primary outcome
Number of therapeutic objectives achieved
Time frame: From baseline to the end of the training program at 12 months
Two therapeutic objectives per participant will be defined at baseline. At the end of the training program, it will be assessed if the objectives were accomplished or not.
Lower extremity muscle strenght
Time frame: Baseline, 3, 6, and 12 months post-training
The Daniels Muscle Testing scale will be used to measure the strength of muscles in the lower extremities at baseline, every 3 months and at the end of the gait training program to assess motor function after the training. Scores range from 0 (absence of muscle activity) to 5 (normal muscle activity)
Modified Ashworth Scale (MAS)
Time frame: Baseline, 3, 6, and 12 months post-training
The Modified Ashworth Scale (MAS) measures spasticity in patients with lesions to the central nervous system. The scale assigns a grade of spasticity from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension). It will be evaluated at baseline, every 3 months and at the end of the gait training program without the device to assess the change in the spasticity after training
Location and level of pain
Time frame: Baseline, 3, 6, and 12 months post-training
The location and level of pain using the numeric rating scale (NRS) will be assessed at baseline, every 3 months and at the end of the gait training program to assess the reduction of pain aftr the training
Timed 25-Feet Walk test (T25FW)
Time frame: Baseline, 3, 6, and 12 months post-training
The Timed 25-Foot Walk (T25FW) test measures the time a person needs to walk 25 feet. This test will be assessed at baseline, every 3 months, and at the end of the gait training program without the device to assess the change in the walking function after the training
6-Minute Walk Test (6MWT)
Time frame: Baseline, 3, 6, and 12 months post-training
The 6-Minute Walk Test (6MWT) measures the distance a person can walk in 6 minutes. This test will be assessed at baseline, every 3 months, and at the end of the gait training program without the device to assess the change in the walking function after the training
Borg Rating of Perceived Exertion
Time frame: Baseline, 3, 6, and 12 months post-training
The Borg Rating of Perceived Exertion (RPE) scale is used to measure a person's perception of their effort and exertion, breathlessness, and fatigue during physical activity. Scores range from 6 (no exertion at all) to 20 (maximal exertion). It will be evaluated during the 6MWT at baseline, every 3 months, and after the end of the gait training program without the device to assess the change in the perceived exertion after the training
Trunk Impairment Scale (TIS)
Time frame: Baseline, 3, 6, and 12 months post-training
The Trunk Impairment Scale (TIS) measures the motor impairment of the trunk through the evaluation of static and dynamic sitting balance as well as coordination of trunk movement. The total score ranges from 0 (minimal performance) to 23 (perfect performance). This test will be assessed at baseline, every 3 months, and at the end of the gait training program without the device to assess the change in the trunk impairment after training
Barthel Index (BI) score
Time frame: Baseline, 3, 6, and 12 months post-training
The Barthel Index (BI) will be used to assess the participants' ability to perform mobility and self-care activities of daily living (ADL). The total score ranges from 0 (total dependency) to 100 (independency). It will be evaluated at baseline, every 3 months, and after the gait training program without the device to assess the change in the independence to perform ADL after the training
Modified Fatigue Impact Scale (MFIS) score
Time frame: Baseline, 3, 6, and 12 months post-training
The Modified Fatigue Impact Scale (MFIS) provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning in persons with multiple sclerosis. The total score ranges from 0 to 84, with higher scores meaning a higher impact of fatigue. It will be evaluated iat baseline, every 3 months and at the end of the gait training program without the device to assess the change in the fatigue after the training
Multiple Sclerosis Quality of Life-54 (MSQoL-54) scores
Time frame: Baseline, 3, 6, and 12 months post-training
The Multiple Sclerosis Quality of Life-54 (MSQoL-54) is a multidimensional health-related quality of life (QoL) measure that combines both generic and MS-specific items into a single instrument. There is no single overall score for the MSQoL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores. The higher the score, the best the outcome. It will be evaluated at baseline, every 3 months and at the end of the gait training program without the device to assess the change in the QoL after the training
Self-perceived impact on general health status
Time frame: 3, 6, and 12 months post-training
Participants' perceptions of the impact on their general health will be evaluated by the completion of a self-report questionnaire on the perceived impact on general health. This questionnaire has been designed by the researchers and intends to identify to what extent participants feel that the ABLE Exoskeleton contributed to a change in their health. The questionnaire covers 7 categories (cardiovascular system, musculoskeletal pain, neuropathic pain, bladder and bowel, spasticity, and sleep quality) using a 7-point Likert scale to assess the change.
Level of motivation
Time frame: After 12 months post-training
Participants' perceptions on the level of motivation generated by the program with the ABLE Exoskeleton will be evaluated by the completion of a self-report questionnaire using a 7-point Likert scale. This questionnaire has been designed by the researchers.
Psychosocial Impact of Assistive Devices Scale (PIADS) score
Time frame: After 12 months post-training
The Psychosocial Impact of Assistive Devices Scale (PIADS) is a 26-item, self-reported questionnaire that provides a measure of user perception and other psychological factors associated with assistive technology devices. Scores range from -78 (maximum negative impact) to +78 (maximum positive impact). It will be used to assess the effects of the ABLE Exoskeleton on functional independence, well-being, and quality of life of participants after the training program experience
Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) score
Time frame: After 12 months post-training
The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) is a 12-item outcome measure that assesses user satisfaction with two components (Device and Services) using a 5-point scale ranging from 1 (not satisfied) to 5 (very satisfied). Only the 8 items referred to the device will be evaluated from participants and the whole 12 items from the therapists to measure user satisfaction with the ABLE Exoskeleton after the training program experience
3 secondary outcomes
Time spent upright and time spent walking
Time frame: At session 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10
Number of steps walked
Time frame: At session 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10
Distance walked
Time frame: At session 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10
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 2 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABLE Exoskeleton in people with Multiple Sclerosis, run by ABLE Human Motion S.L. at 1 site in Spain.
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 4 inclusion and 18 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 2 Jun 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 Spain. 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. 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?
Number of therapeutic objectives achieved (time frame: From baseline to the end of the training program at 12 months). The study lists 15 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 2 Jun 2026.