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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 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-08-04

No results posted yet for this 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.

Conditions

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Som·hi Rehab

    collaborator UNKNOWN

  • ABLE Human Motion S.L.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07745712 on ClinicalTrials.gov