Ireland
--:--IST
Recruiting Not 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

NCT07745712 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2026-09-01
Last updated
2026-09-08

Condition(s) studied

Gait ImpairmentCerebral Palsy (CP)Neuromuscular Diseases (NMD)Spinal Cord Injuries (SCI)Spina BifidaMuscular WeaknessAcquired Brain Injury (Including Stroke)

Investigational drug(s) / intervention(s)

ABLE Kids

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

Sex
ALL
Min age
—
Max age
17 Years
Healthy volunteers
No
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 (Modified Ashworth Scale \[MAS\] \> 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 (Migration Percentage \[MP\] \> 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 limitations preventing use of the exoskeleton: * Knee flexion contracture ≥40° * Hip flexion contracture ≥20° * Rigid equinus foot * Spine or lower extremity surgery within the last 3 months * Recently implanted pacemakers * Inability to communicate pain, fear, or discomfort (verbally or nonverbally) * Daytime mechanical ventilation * Uncontrolled epileptic seizures * Medical or cardiovascular instability * Considered unsuitable by physicians and physiotherapists. Any acute medical condition such as fever, infection, respiratory problems, urinary symptoms, uncontrolled pain, new swelling or redness in the extremities, active deep vein thrombosis, or severe comorbidities considered incompatible with the use of ABLE Kids until clinical resolution * Absence of head or trunk control in sitting or standing that cannot be compensated through the use of orthotic support during exoskeleton use

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)

FacilityCityRegionStatus
Som·hi Rehab Girona Girona Recruiting
Official registry record

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