An interventional study of ABLE Kids in Gait Impairment, Cerebral Palsy (CP) and Neuromuscular Diseases (NMD), sponsored by ABLE Human Motion S.L.. Recruiting at 1 site in Spain. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by ABLE Human Motion S.L. · Not applicable, Interventional, and Treatment
The primary objective of the study is to validate the safety and clinical performance of the ABLE Kids device in pediatric patients with neurological gait disorders or muscular weakness 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.
This is a pre-post, single-center, quasi-experimental study with an estimated duration of 17 weeks. The study will be conducted at Som·hi where a minimum of 10 evaluable participants are expected to be recruited within a period of 11 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 Kids device for a maximum duration of 3 weeks. Sessions will be conducted 5 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.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
This study's planned enrollment of 15 is below the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →ABLE Human Motion S.L. is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will undergo a 10-session gait training program with the exoskeleton, five times a week for up to 3 weeks. Each session will last 60 minutes.
Device: ABLE Kids
Participants will undergo a 10-session gait training program with the exoskeleton, five times a week for up to 3 weeks. Each session will last 60 minutes.
Number and type of device-related Adverse Events
To assess safety, the number of Serious Adverse Events (SAE), Adverse Events (AE) and drop-outs due to the device will be assessed and reported.
Time frame: From baseline to follow-up (up to 2 weeks after end of intervention)
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.
Time frame: Up to 3 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
Time frame: 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
Time frame: 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
Time frame: Up to 6 weeks
Number of people assisting the session
In each gait training session, the number of people assisting will be recorded
Time frame: Up to 6 weeks
Lower extremity muscle strength
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)
Time frame: At baseline (day 0) and post-training (up to 4 weeks)
Gross Motor Function Measure-88
The Gross Motor Function Measure-88 (GMFM-88) is a standardized observational instrument designed to assess changes in gross motor function in children with motor impairments. It consists of 88 items grouped into five dimensions: lying and rolling, sitting, crawling and kneeling, standing, and walking/running/jumping. Each item is scored on a 4-point ordinal scale, with higher scores indicating better gross motor performance.
Time frame: At baseline (day 0) and post-training (up to 4 weeks)
Motor Function Measure-20
The Motor Function Measure-20 (MFM-20) is a validated scale used to assess motor function in children with neuromuscular disorders. It evaluates functional abilities across three domains: standing position and transfers, axial and proximal motor function, and distal motor function. The scale consists of 20 items scored on a 4-point ordinal scale, with higher scores reflecting better motor performance.
Time frame: At baseline (day 0) and post-training (up to 4 weeks)
10-Meter Walk Test (10MWT)
The 10-Meter Walk Test (10MWT) 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.
Time frame: At baseline (day 0) and post-training (up to 4 weeks)
2-Minute Walk Test (2MWT)
The 2-Minute Walk Test (2MWT) measures the distance a person can walk in 2 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
Time frame: At baseline (day 0) and post-training (up to 4 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).
Time frame: At selection, baseline and post-training (up to 4 weeks)
Pediatric Balance Scale (PBS)
The Pediatric Balance Scale (PBS) is a standardized clinical assessment used to evaluate functional balance in children. Adapted from the Berg Balance Scale, it consists of 14 tasks commonly performed in everyday activities, such as sitting, standing, reaching, turning, and transferring. Each item is scored on a 5-point scale from 0 to 4, with higher scores indicating better balance performance.
Time frame: At baseline and post-training (up to 4 weeks)
Location and level of pain - Faces Pain Scale-Revised
The Faces Pain Scale-Revised (FPS-R) is a self-report instrument used to assess pain intensity in children. The scale presents a series of faces representing increasing levels of pain intensity, allowing participants to select the face that best matches their pain experience. Pain location is additionally recorded based on the participant's report. Higher scores indicate greater pain intensity.
Time frame: From baseline to post-training (up to 4 weeks)
OMNI Rating of Perceived Exertion
The OMNI Rating of Perceived Exertion Scale is a validated self-report measure used to assess perceived physical effort during exercise in pediatric populations. The scale combines numerical ratings with verbal descriptors and pictorial representations to help children quantify their level of exertion during physical activity. Higher scores indicate greater perceived exertion.
Time frame: From baseline to post-training (up to 4 weeks)
Functional Independence Measure for Children (WeeFIM)
The Functional Independence Measure for Children (WeeFIM) is a standardized instrument used to assess functional independence in children. It evaluates performance in self-care, mobility, and cognition through 18 items scored on a 7-level scale, where 1 indicates total assistance and 7 indicates complete independence. Higher scores reflect greater functional independence in activities of daily living.
Time frame: At baseline and post-training (up to 4 weeks)
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 Kids contributed to a change in their health. The questionnaire covers 7 categories (cardiovascular system, musculoskeletal pain, neuropathic pain, bladder and bowel, skin, spasticity, and sleep quality) using a 7-point Likert scale to assess the change.
Time frame: At post-training (up to 4 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 Kids after the training program experience
Time frame: At post-training (up to 4 weeks)
EuroQol 5 Dimensions Youth - 5 Levels (EQ-5D-Y-5L)
The EQ-5D-Y-5L is a standardized self-reported instrument used to assess health-related quality of life in children and adolescents. It evaluates five dimensions: mobility, looking after myself, doing usual activities, having pain or discomfort, and feeling worried, sad, or unhappy. Each dimension is rated on a 5-level scale ranging from "no problems" to "extreme problems." The instrument also includes a EuroQol Visual Analogue Scale (EQ VAS) for the participant's overall perception of their health status.
Time frame: At baseline and post-training (up to 4 weeks)
Plan to share: No
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