Clinical Investigation to Validate the Safety and Performance of the ABLE Kids Device in Pediatric Patients With Neurological Gait Disorders in a Clinical Setting

Starting soon · Not applicable

Conditions studied: Gait Impairment, Aquired Brain Injury, Cerebral Palsy (CP), Neuromuscular Diseases (NMD), Spinal Cord Injuries (SCI), Spina Bifida, Muscular Weakness

In brief

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.

Key facts

Study ID

NCT07745712

Run by

ABLE Human Motion S.L.

People needed

15

Starts

2026-09-01

Expected to finish

2026-12-31

Last updated by the study team

2026-08-04

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 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

Where it is running

• Som·hi Rehab — Girona, Girona, Spain

Full record on ClinicalTrials.gov

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