Multiple SclerosisNCT06261541
Clinical Investigation to Validate the Safety and Performance of the ABLE Exoskeleton Device for Individuals With Multiple Sclerosis in a Clinical Setting
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 primary objective of the study is to validate the safety and performance of the ABLE Exoskeleton device in people with multiple sclerosis during a 10-session gait training program in a clinical setting. 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
- 33 participants
- Where
- 1 siteSpain
- Study dates
- 8 Apr 2024to 30 Jul 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 70 years of age.
- Diagnosed with MS.
- Currently receiving treatment as an inpatient or outpatient at one of the investigational 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 of standing.
- Uncontrolled autonomic dysreflexia.
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- Medically unstable
- 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 primary objective of the study is to validate the safety and performance of the ABLE Exoskeleton device in people with multiple sclerosis during a 10-session gait training program in a clinical setting. Furthermore, the potential effects of the training on walking, and balance function, general health status, user satisfaction, and quality of life will be assessed.
Read the detailed description
This is a pre-post, single-center, quasi-experimental study with an estimated duration of 4 months since the approval date. The study will be conducted at the Fundación Esclerosis Múltiple de Madrid (FEMM), where a minimum of 20 participants are expected to be recruited over a maximum period of 2 months since the approval date.
After obtaining informed consent, through the Patient Information Sheet and the Informed Consent Form, the selection of the participants will be carried out to determine their inclusion in the study. Subjects who do not meet all the inclusion and exclusion criteria during the screening visit will be excluded from the study. At the latest, one week after the screening visit, the participants will undergo a preliminary assessment without the medical device.
Participants will undergo a 10-session training program with the ABLE Exoskeleton device for a maximum duration of 11 weeks. Sessions will be conducted 1 to 2 times per week, depending on the participant's availability. Each session will last approximately 60 minutes. During the training period, session data will be taken to assess the safety and clinical performance of the device. At the latest, one week after the last training session, a post-training assessment will be performed. Finally, two weeks after the last training session, a follow-up assessment will be made to the participants via a telephone call to review any adverse events (AE) reported between the end of the training and the follow-up.
This is the first study investigating the use of the ABLE Exoskeleton in people with MS, therefore the primary hypothesis of this study is that the ABLE Exoskeleton is safe and has adequate performance for the intended MS population in a clinical setting. The secondary hypothesis is that the device will have a positive impact on the muscular strength, spasticity, perceived rate of exertion, mobility, satisfaction, and quality of life of the study participants.
- Conditions
- Multiple Sclerosis
- Being tested
- ABLE Exoskeleton
- Keywords
- Lower-limb exoskeleton, Gait training
- 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 with MS will undergo a training program with the ABLE Exoskeleton device: a total of 10 sessions, distributed 1-2 sessions/week for up to 11 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Gait training with exoskeleton | Experimental | Participants with MS will undergo a training program with the ABLE Exoskeleton device: a total of 10 sessions, distributed 1-2 sessions/week for up to 11 weeks. Receives: Device: ABLE Exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and type of device-related Adverse Events
To assess safety, the number of Severe Adverse Events (SAE), Adverse Events (AE) and drop-outs due to the device will be assessed and reported.
Measured: Up to 16 weeks
Level of Assistance (LoA) to don/doff the device
Level of Assistance (LoA) to don/doff the device will be measured in every session. The level of assistance will be measured using a 6-item scale, from Total assistance to Independence, with Independence being the best outcome possible. Different assistance levels are defined taking into account the degree of participation of both the participant and the therapist on performing the activity.
Measured: Up to 11 weeks
Time taken to don/doff the device
The time taken to don/doff the device will be measured in every session. Time will be measured in minutes and seconds for each activity. Donning time will start from the moment the participant is ready to transfer into the device until all the straps and clips are correctly tightened. Doffing time will start from the moment the participant starts taking off the device until they have completely removed it.
Measured: Up to 11 weeks
Level of Assistance (LoA) to complete therapy activity tasks
Four therapy activity tasks will be attempted every session by the participant. The therapist will record the level of assistance required to complete each task during the session, using a 6-item scale, from Total assistance to Independence, with Independence being the best outcome possible. The tasks are the following: sit-to-stand, walk 10 meters, turn 180 degrees, and stand-to-sit.
Measured: Up to 11 weeks
Time spent upright and time spent walking
In each 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: Up to 11 weeks
Number of steps walked
In each session, the number of steps taken (step count) with the device will be automatically measured and registered by the device.
Measured: Up to 11 weeks
Distance walked
In each session, the distance walked (in meters) with the device will be automatically measured and registered by the device.
Measured: Up to 11 weeks
Secondary outcomes (13)
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 performed in the pre-post evaluations without the device to assess the change in the walking function after the training.
Measured: Up to 11 weeks
Ambulation Index (AI)
The Ambulation Index (AI) is a rating scale that assesses mobility based on time and degree of assistance required when walking 25 feet as quickly as possible but safely. Scores range from 0 (asymptomatic and fully active) to 10 (bedridden). This test will be performed in the pre-post evaluations without the device to assess the change in the walking function after the training.
Measured: Up to 11 weeks
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 performed in the pre-post evaluations without the device to assess the change in the walking function after the training.
Measured: Up to 11 weeks
Timed Up-and-Go test (TUG)
The Timed Up-and-Go Test (TUG) measures the time it takes a person to get up from a chair, walk 3 meters, turn around, and sit down again. This test will be performed in the pre-post evaluations without the device to assess the change in the walking function after the training.
Measured: Up to 11 weeks
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 performed in the pre-post evaluations without the device to assess the change in the trunk impairment after training.
Measured: Up to 11 weeks
Lower extremity muscle strenght
The Daniels Muscle Testing scale will be used to measure the strength of muscles in the lower extremities in the pre-post evaluations to assess motor function after the training. Scores range from 0 (absence of muscle activity) to 5 (normal muscle activity).
Measured: Up to 11 weeks
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 in the pre-post evaluations without the device to assess the change in the spasticity after training.
Measured: Up to 11 weeks
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 in the pre-post evaluations without the device to assess the change in the perceived exertion after the training.
Measured: Up to 11 weeks
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 in the pre-post evaluations without the device to assess the change in the independence to perform ADL after the training.
Measured: Up to 11 weeks
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 in the pre-post evaluations without the device to assess the change in the fatigue after the training.
Measured: Up to 11 weeks
Multiple Sclerosis Quality of Life-54 (MSQoL-54)
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 in the pre-post evaluations without the device to assess the change in the QoL after the training.
Measured: Up to 11 weeks
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: Up to 11 weeks
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 to measure user satisfaction from participants and therapists with the ABLE Exoskeleton after the training program experience.
Measured: Up to 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start8 Apr 2024
- Primary completion30 Jul 2024
- Study completion30 Jul 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 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
- NCT06261541
- Sponsor's protocol ID
- ABLEexoMS
- Status last verified
- May 2024
- First submitted
- 30 Jan 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation to Validate the Safety and Performance of the ABLE Exoskeleton Device for Individuals With Multiple Sclerosis in a Clinical Setting
- ClinicalTrials.gov ID
- NCT06261541
- Acronym / sponsor ID
- ABLEexoMS
- Conditions
- Multiple Sclerosis
- Keywords
- Lower-limb exoskeleton, Gait training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- ABLE Human Motion S.L.Industry (pharma, biotech, devices)
- Collaborators
- Fundación Esclerosis Múltiple Madrid (FEMM)
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 15 Feb 2024 (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 primary objective of the study is to validate the safety and performance of the ABLE Exoskeleton device in people with multiple sclerosis during a 10-session gait training program in a clinical setting. Furthermore, the potential effects of the training on walking, and balance function, general health status, user satisfaction, and quality of life will be assessed.
Detailed description
This is a pre-post, single-center, quasi-experimental study with an estimated duration of 4 months since the approval date. The study will be conducted at the Fundación Esclerosis Múltiple de Madrid (FEMM), where a minimum of 20 participants are expected to be recruited over a maximum period of 2 months since the approval date.
After obtaining informed consent, through the Patient Information Sheet and the Informed Consent Form, the selection of the participants will be carried out to determine their inclusion in the study. Subjects who do not meet all the inclusion and exclusion criteria during the screening visit will be excluded from the study. At the latest, one week after the screening visit, the participants will undergo a preliminary assessment without the medical device.
Participants will undergo a 10-session training program with the ABLE Exoskeleton device for a maximum duration of 11 weeks. Sessions will be conducted 1 to 2 times per week, depending on the participant's availability. Each session will last approximately 60 minutes. During the training period, session data will be taken to assess the safety and clinical performance of the device. At the latest, one week after the last training session, a post-training assessment will be performed. Finally, two weeks after the last training session, a follow-up assessment will be made to the participants via a telephone call to review any adverse events (AE) reported between the end of the training and the follow-up.
This is the first study investigating the use of the ABLE Exoskeleton in people with MS, therefore the primary hypothesis of this study is that the ABLE Exoskeleton is safe and has adequate performance for the intended MS population in a clinical setting. The secondary hypothesis is that the device will have a positive impact on the muscular strength, spasticity, perceived rate of exertion, mobility, satisfaction, and quality of life of the study participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gait training with exoskeleton | Experimental | Device: ABLE ExoskeletonParticipants with MS will undergo a training program with the ABLE Exoskeleton device: a total of 10 sessions, distributed 1-2 sessions/week for up to 11 weeks. |
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 of age.
- Diagnosed with MS.
- Currently receiving treatment as an inpatient or outpatient at one of the investigational 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 of 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 with MS will undergo a training program with the ABLE Exoskeleton device: a total of 10 sessions, distributed 1-2 sessions/week for up to 11 weeks. | Device | Gait training with exoskeleton |
Primary outcome
Number and type of device-related Adverse Events
Time frame: Up to 16 weeks
To assess safety, the number of Severe Adverse Events (SAE), Adverse Events (AE) and drop-outs due to the device will be assessed and reported.
Level of Assistance (LoA) to don/doff the device
Time frame: Up to 11 weeks
Level of Assistance (LoA) to don/doff the device will be measured in every session. The level of assistance will be measured using a 6-item scale, from Total assistance to Independence, with Independence being the best outcome possible. Different assistance levels are defined taking into account the degree of participation of both the participant and the therapist on performing the activity.
Time taken to don/doff the device
Time frame: Up to 11 weeks
The time taken to don/doff the device will be measured in every session. Time will be measured in minutes and seconds for each activity. Donning time will start from the moment the participant is ready to transfer into the device until all the straps and clips are correctly tightened. Doffing time will start from the moment the participant starts taking off the device until they have completely removed it.
Level of Assistance (LoA) to complete therapy activity tasks
Time frame: Up to 11 weeks
Four therapy activity tasks will be attempted every session by the participant. The therapist will record the level of assistance required to complete each task during the session, using a 6-item scale, from Total assistance to Independence, with Independence being the best outcome possible. The tasks are the following: sit-to-stand, walk 10 meters, turn 180 degrees, and stand-to-sit.
Time spent upright and time spent walking
Time frame: Up to 11 weeks
In each 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.
Number of steps walked
Time frame: Up to 11 weeks
In each session, the number of steps taken (step count) with the device will be automatically measured and registered by the device.
Distance walked
Time frame: Up to 11 weeks
In each session, the distance walked (in meters) with the device will be automatically measured and registered by the device.
13 secondary outcomes
Timed 25-Feet Walk test (T25FW)
Time frame: Up to 11 weeks
Ambulation Index (AI)
Time frame: Up to 11 weeks
6-Minute Walk Test (6MWT)
Time frame: Up to 11 weeks
Timed Up-and-Go test (TUG)
Time frame: Up to 11 weeks
Trunk Impairment Scale (TIS)
Time frame: Up to 11 weeks
Lower extremity muscle strenght
Time frame: Up to 11 weeks
Modified Ashworth Scale (MAS)
Time frame: Up to 11 weeks
Borg Rating of Perceived Exertion
Time frame: Up to 11 weeks
Barthel Index (BI) score
Time frame: Up to 11 weeks
Modified Fatigue Impact Scale (MFIS) score
Time frame: Up to 11 weeks
Multiple Sclerosis Quality of Life-54 (MSQoL-54)
Time frame: Up to 11 weeks
Psychosocial Impact of Assistive Devices Scale (PIADS) score
Time frame: Up to 11 weeks
Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) score
Time frame: Up to 11 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 31 Jul 2024.
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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 31 Jul 2024. 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 and type of device-related Adverse Events (time frame: Up to 16 weeks). The study lists 7 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 31 Jul 2024.