Acquired Brain Injury (Including Stroke)NCT07050875
Clinical Investigation to Validate the Safety and Performance of the ABLE Exoskeleton Device for Individuals With Acquired Brain Injury in a Clinical Setting
A study testing ABLE Exoskeleton in people with Acquired Brain Injury (Including Stroke), run by ABLE Human Motion S.L. at 3 sites in Spain.
Trial summary
The primary objective of the study is to validate the safety and clinical performance of the ABLE Exoskeleton device in people with acquired brain injury during a 10-session gait training program in a clinical setting. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acquired Brain Injury (Including Stroke)
- 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
- 14 participants
- Where
- 3 sitesSpain
- Study dates
- 30 Jun 2025to 17 Dec 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 80 years old
- Diagnosed with acquired brain injury (ABI)
- Currently undergoing outpatient physical therapy treatment in one of the investigation sites
- 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 10 minutes standing
- Uncontrolled autonomic dysreflexia
Show all 20Show fewer
- Medical instability
- Unstable cardiovascular system (CVS), hemodynamic instability, untreated hypertension (SBP>140, DBP>90 mmHg), unresolved deep venous thrombosis (DVT), uncontrolled autonomic dysreflexia
- 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 leg 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
- Requires assisted ventilation.
- Scoliosis >40-50º Cobb angle.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Cefine Neurología (CEFINE)
Culleredo, A Coruña, 15174
Fundación Step by Step
L'Hospitalet de Llobregat, Barcelona, 08908
Centro Europeo de Neurociencias (CEN)
Madrid, Madrid, 28023
About this study
The primary objective of the study is to validate the safety and clinical performance of the ABLE Exoskeleton device in people with acquired brain injury during a 10-session gait training program in a clinical setting.
The secondary objective of the study focuses on obtaining preliminary data on the potential clinical and psychosocial benefits of the product.
Read the detailed description
This is a pre-post, multicenter, quasi-experimental study with an estimated duration of 17 weeks. The study will be conducted at the Centro Europeo de Neurociencias (CEN), Cefine Neurología (CEFINE), and Fundación Step by Step Foundation, where a minimum of 15 participants (5 per center) are expected to be recruited within a period of 8 weeks.
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 baseline assessment without the medical device.
Participants will undergo a 10-session training program with the ABLE Exoskeleton device for a maximum duration of 6 weeks. Sessions will be conducted 2 times per week. 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.
- Conditions
- Acquired Brain Injury (Including Stroke)
- Being tested
- ABLE Exoskeleton
- Keywords
- Gait training, Wearable exoskeleton, Acquired Brain Injury, Lower-limb exoskeleton, Multicenter
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABLE ExoskeletonDevice
Participants will undergo a 10-session gait training program with the exoskeleton, twice a week for up to 6 weeks. Each session will last 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Gait training with exoskeleton | Experimental | Participants will undergo a 10-session gait training program with the exoskeleton, twice a week for up to 6 weeks. Each session will last 60 minutes. 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: From baseline to follow-up (up to 2 weeks after end of intervention)
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 6 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 6 weeks
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: Up to 6 weeks
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: Up to 6 weeks
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: Up to 6 weeks
Number of therapists assisting the session
In each gait training session, the number of therapists assisting will be recorded
Measured: Up to 6 weeks
Level of Assistance (LoA) during training
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 6 weeks
Secondary outcomes (15)
Lower extremity muscle strenght
The Daniels Muscle Testing scale will be used to measure the strength of muscles in the lower extremities. Scores range from 0 (absence of muscle activity) to 5 (normal muscle activity)
Measured: At baseline (day 0) and post-training (up to 7 weeks)
Functional Ambulation Category (FAC)
The patient's walking ability is evaluated with the Functional Ambulation Category (FAC) scale. It has 6 categories, from 0 (patient who is not able to walk) to 5 (independent patient who does not need any help to walk)
Measured: At baseline(day 0) and post-training (up to 7 weeks)
10-Meter Walking Test (10MWT)
The 10-Meter Walking Test (10MWT) test measures the time a person needs to walk 10 meters. 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: At baseline(day 0) and post-training (up to 7 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 assessed at baseline and at the end of the gait training program without the device to assess the change in the walking function after the training
Measured: At baseline (day 0) and post-training (up to 7 weeks)
Timed Up and Go (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: At baseline (day 0) and post-training (up to 7 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).
Measured: At baseline (day 0) and post-training (up to 7 weeks)
Berg Balance Scale (BBS)
The Berg Balance Scale (BBS) is used to assess the patient's ability to safely stabilize while performing certain tasks. It consists of a list of 14 items.
Each item is evaluated through an ordinal scale ranging from 0 (lowest level of functionality) to 4 (highest level of functionality).
Measured: At baseline and post-training (up to 7 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).
Measured: At selection, baseline and post-training (up to 7 weeks)
Location and level of pain
The location and level of pain using the numeric rating scale (NRS) will be assessed. Each value is scored on a 0 to 10 scale, where 0 represents no pain and 10 represents the worst pain imaginable.
Measured: From baseline to post-training (up to 7 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).
Measured: From baseline to post-training (up to 7 weeks)
Functional Independence Measure (FIM)
The Functional Independence Scale (FIM) is a widely used instrument to assess the patient's outcomes and progress in rehabilitation programs. It is an indicator of disability, which measures how much assistance the patient needs to perform activities of daily living . It includes 18 activities that are measured on a 7-level scale, with 1 being indicative of total assistance and 7 of complete independence.
Measured: At baseline and post-training (up to 7 weeks)
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: At post-training (up to 7 weeks from baseline)
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: At post-training (up to 7 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: At post-training (up to 7 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 from participants and the whole 12 items from the therapists to measure user satisfaction with the ABLE Exoskeleton after the training program experience
Measured: At post-training (up to 7 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start30 Jun 2025
- Primary completion17 Dec 2025
- Study completion17 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain Injury (Including Stroke)Studies 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- ABLE Human Motion S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centro Europeo de Neurociencias (CEN), Cefine Neurología (CEFINE), Fundación Step by Step (SBS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050875
- Sponsor's protocol ID
- ABLEexoABI
- Other IDs
- CIV-25-04-052374
- Status last verified
- Jan 2026
- First submitted
- 16 Jun 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. 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 Acquired Brain Injury in a Clinical Setting
- ClinicalTrials.gov ID
- NCT07050875
- Acronym / sponsor ID
- ABLEexoABI
- Conditions
- Acquired Brain Injury (Including Stroke)
- Keywords
- Gait training, Wearable exoskeleton, Acquired Brain Injury, Lower-limb exoskeleton, Multicenter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- ABLE Human Motion S.L.Industry (pharma, biotech, devices)
- Collaborators
- Centro Europeo de Neurociencias (CEN), Cefine Neurología (CEFINE), Fundación Step by Step (SBS)
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 17 Dec 2025 (actual)
- Study completion
- 17 Dec 2025 (actual)
- First posted
- 3 Jul 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 primary objective of the study is to validate the safety and clinical performance of the ABLE Exoskeleton device in people with acquired brain injury during a 10-session gait training program in a clinical setting.
The secondary objective of the study focuses on obtaining preliminary data on the potential clinical and psychosocial benefits of the product.
Detailed description
This is a pre-post, multicenter, quasi-experimental study with an estimated duration of 17 weeks. The study will be conducted at the Centro Europeo de Neurociencias (CEN), Cefine Neurología (CEFINE), and Fundación Step by Step Foundation, where a minimum of 15 participants (5 per center) are expected to be recruited within a period of 8 weeks.
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 baseline assessment without the medical device.
Participants will undergo a 10-session training program with the ABLE Exoskeleton device for a maximum duration of 6 weeks. Sessions will be conducted 2 times per week. 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.
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 will undergo a 10-session gait training program with the exoskeleton, twice a week for up to 6 weeks. Each session will last 60 minutes. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 to 80 years old
- Diagnosed with acquired brain injury (ABI)
- Currently undergoing outpatient physical therapy treatment in one of the investigation sites
- Ability to give informed consent
Key exclusion criteria (20 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 10 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 a 10-session gait training program with the exoskeleton, twice a week for up to 6 weeks. Each session will last 60 minutes. | Device | Gait training with exoskeleton |
Primary outcome
Number and type of device-related Adverse Events
Time frame: From baseline to follow-up (up to 2 weeks after end of intervention)
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 6 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 6 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.
Number of steps walked
Time frame: Up to 6 weeks
In each gait training 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 6 weeks
In each gait training session, the distance walked (in meters) with the device will be automatically measured and registered by the device
Time spent upright and time spent walking
Time frame: Up to 6 weeks
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
Number of therapists assisting the session
Time frame: Up to 6 weeks
In each gait training session, the number of therapists assisting will be recorded
Level of Assistance (LoA) during training
Time frame: Up to 6 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.
15 secondary outcomes
Lower extremity muscle strenght
Time frame: At baseline (day 0) and post-training (up to 7 weeks)
Functional Ambulation Category (FAC)
Time frame: At baseline(day 0) and post-training (up to 7 weeks)
10-Meter Walking Test (10MWT)
Time frame: At baseline(day 0) and post-training (up to 7 weeks)
6-Minute Walk Test (6MWT)
Time frame: At baseline (day 0) and post-training (up to 7 weeks)
Timed Up and Go (TUG)
Time frame: At baseline (day 0) and post-training (up to 7 weeks)
Trunk Impairment Scale (TIS)
Time frame: At baseline (day 0) and post-training (up to 7 weeks)
Berg Balance Scale (BBS)
Time frame: At baseline and post-training (up to 7 weeks)
Modified Ashworth Scale (MAS)
Time frame: At selection, baseline and post-training (up to 7 weeks)
Location and level of pain
Time frame: From baseline to post-training (up to 7 weeks)
Borg Rating of Perceived Exertion
Time frame: From baseline to post-training (up to 7 weeks)
Functional Independence Measure (FIM)
Time frame: At baseline and post-training (up to 7 weeks)
Level of motivation
Time frame: At post-training (up to 7 weeks from baseline)
Self-perceived impact on general health status
Time frame: At post-training (up to 7 weeks)
Psychosocial Impact of Assistive Devices Scale (PIADS) score
Time frame: At post-training (up to 7 weeks)
Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) score
Time frame: At post-training (up to 7 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 27 Jan 2026.
- Individual participant dataSharing planned: No
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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.
3 sites 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 Acquired Brain Injury (Including Stroke), run by ABLE Human Motion S.L. at 3 sites 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 20 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 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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: From baseline to follow-up (up to 2 weeks after end of intervention)). The study lists 8 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 27 Jan 2026.