Clinical Investigation to Validate the Safety and Performance of the ABLE Kids Device in Pediatric Patients With Neurological Gait Disorders in a Clinical Setting
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Number and type of device-related Adverse Events — From baseline to follow-up (up to 2 weeks after end of intervention)
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 taken to don/doff the device — Up to 3 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 — 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 — 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 — 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 people assisting the session — Up to 6 weeks
In each gait training session, the number of people assisting will be recorded
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Som·hi Rehab | Girona | Girona | Recruiting |
More ABLE Human Motion S.L. trials in Spain
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07745712 on ClinicalTrials.gov ↗ ← All trials in Spain