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 | Not Yet Recruiting

• 1 other identifier: ABLEkidsSP
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

gait training; wearable exoskeleton; lower-limb exoskeleton

Outcome Measures

Primary Outcomes (6)

• Number and type of device-related Adverse Events

  To assess safety, the number of Severe Adverse Events (SAE), Adverse Events (AE) and drop-outs due to the device will be assessed and reported.

  From baseline to follow-up (up to 2 weeks after end of intervention)

• Time taken to don/doff the device

  he 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.

  Up to 3 weeks

• Number of steps walked

  In each gait training session, the number of steps taken (step count) with the device will be automatically measured and registered by the device

  Up to 6 weeks

• Distance walked

  In each gait training session, the distance walked (in meters) with the device will be automatically measured and registered by the device

  Up to 6 weeks

• Time spent upright and time spent walking

  n 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

  Up to 6 weeks

• Number of people assisting the session

  In each gait training session, the number of people assisting will be recorded

  Up to 6 weeks

Secondary Outcomes (13)

• Lower extremity muscle strenght

  At baseline (day 0) and post-training (up to 4 weeks)

• Gross Motor Function Measure-88

  At baseline (day 0) and post-training (up to 4 weeks)

• Motor Function Measure-20

  At baseline (day 0) and post-training (up to 4 weeks)

• 10-Meter Walking Test (10MWT)

  At baseline(day 0) and post-training (up to 4 weeks)

• 2-Minute Walking Test (2MWT)

  At baseline(day 0) and post-training (up to 4 weeks)

Study Arms (1)

Gait training with exoskeleton

EXPERIMENTAL

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.

Device: ABLE Kids

Interventions

ABLE Kids DEVICE

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.

Gait training with exoskeleton

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• ABLE Human Motion S.L.: lead
• Som·hi Rehab: collaborator

Study Sites (1)

Som·hi Rehab

Girona, Girona, 17001, Spain

Location

MeSH Terms

Conditions

Cerebral Palsy; Neuromuscular Diseases; Spinal Cord Injuries; Spinal Dysraphism; Muscle Weakness

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Trauma, Nervous System; Wounds and Injuries; Neural Tube Defects; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Nuria Maspoch Clemente

CONTACT

+34 634 64 34 96; maspochnuria@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 4, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)