Able Kids device: safer gait aid for kids with neurologic gait problems

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, pre-post study evaluating safety and clinical performance of the ABLE Kids device in pediatric patients with gait impairments due to neurological conditions or muscular weakness. Participants undergo baseline assessment, followed by a 10-session, 60-minute per session gait training program over up to three weeks, with data collected on safety and device performance. A post-training assessment occurs within one week after training, and a follow-up call two weeks later to capture any adverse events. The study aims to gather preliminary data on potential clinical and psychosocial benefits, while ensuring eligibility through specific anthropometric and clinical criteria. Recruitment targets at least 10 evaluable participants within about 11 weeks at a single center in Girona, Spain.

Why it matters

Who can join: the full rules

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

Where it's running

• Som·hi Rehab
  Girona, Girona, Spain Recruiting

Study contacts

• Study coordinator: Nuria Maspoch Clemente
• Email: maspochnuria@gmail.com
• Phone: +34 634 64 34 96

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.