Clinical Investigation to Validate the Safety and Performance of the ABLE Kids Device in Pediatri… (NCT07745712) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Investigation to Validate the Safety and Performance of the ABLE Kids Device in Pediatric Patients With Neurological Gait Disorders in a Clinical Setting
Spain15 participantsStarted 2026-09-01
Plain-language 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.
Who can participate
Age range
17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Minors with gait impairments, ranging from mild to severe, resulting from neurological conditions or muscular weakness
* Anthropometric measurements compatible with the use of the exoskeleton, particularly:
* Weight under 75 kg
* Height between 1.0-1.5 m
* Hip: maximum distance between greater trochanters of 35 cm
* Thigh: maximum distance from trochanter to knee joint line of 36 cm
* Lower leg: maximum distance from knee joint line to shoe sole of 45 cm
* Medically stable
* Intact skin in areas in contact with the device
* Favorable medical assessment for standing, gait training, and weight-bearing activities
* Signed informed consent from parents or legal guardians, and assent from the minor whenever possible, according to age and cognitive ability
Exclusion Criteria:
* Severe spasticity in the lower limbs (MAS \> 3)
* Severe osteoporosis resulting in atraumatic bone fractures
* Unhealed fractures or history of fragility fractures in the lower extremities within the past 2 years
* Unstable or painful hip dislocation (MP \> 50)
* Symptomatic heterotopic ossification with mechanical limitation or pain
* Anatomical limitations incompatible with proper fitting and safe use of the device:
* Leg length discrepancy \>1.5 cm in the upper segment or \>2.0 cm in the lower segment
* Severe scoliosis (Cobb angle \>40° without the possibility of orthotic use during operation)
* Inability to achieve proper adjustment within the device
* Joint range of motion limi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is focused on validating safety and performance of the ABLE Kids device rather than testing a treatment, what does that mean for my child — would they be helping to prove the device is safe, and could there be risks we don't yet fully understand since it hasn't been recruited for yet?
2The trial is measuring practical things like how many steps my child can walk, how long it takes to put the device on and off, and how many people are needed to help — based on my child's current mobility and condition, does my doctor think my child would realistically be able to participate in those kinds of sessions?
3This trial covers several different neurological conditions including cerebral palsy, spinal cord injury, and acquired brain injury — does my doctor think the device is likely to be equally useful across all those conditions, or is the evidence stronger for some diagnoses than others?
4Since the trial isn't recruiting yet, what standard therapy or assistive device options are available for my child right now that we could pursue while waiting to see if this study opens?
5If my child did take part, what kind of clinical setting would the sessions happen in, and how much time and travel would realistically be involved for our family?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number and type of device-related Adverse Events
Timeframe: From baseline to follow-up (up to 2 weeks after end of intervention)