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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cerebral Palsy (CP); Spina Bifida; Gait Impairment; Spinal Cord Injuries (SCI); Muscular Weakness; Acquired Brain Injury (Including Stroke); Neuromuscular Diseases (NMD)
• Intervention / Treatment: Device: ABLE Kids

Detailed Description

This is a pre-post, single-center, quasi-experimental study with an estimated duration of 17 weeks. The study will be conducted at Som·hi where a minimum of 10 evaluable participants are expected to be recruited within a period of 11 weeks.

After obtaining informed consent, through the Patient Information Sheet and the Informed Consent Form, the selection of the participants will be carried out to determine their inclusion in the study. Subjects who do not meet all the inclusion and exclusion criteria during the screening visit will be excluded from the study. At the latest, one week after the screening visit, the participants will undergo a baseline assessment without the medical device.

Participants will undergo a 10-session training program with the ABLE Kids device for a maximum duration of 3 weeks. Sessions will be conducted 5 times per week. Each session will last approximately 60 minutes. During the training period, session data will be taken to assess the safety and clinical performance of the device. At the latest, one week after the last training session, a post-training assessment will be performed. Finally, two weeks after the last training session, a follow-up assessment will be made to the participants via a telephone call to review any adverse events (AE) reported between the end of the training and the follow-up.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nuria Maspoch Clemente; Phone Number: +34 634 64 34 96; Email: maspochnuria@gmail.com

Study Locations

• Spain
  • Girona
    • Girona, Girona, Spain, 17001
      • Som·hi Rehab
      • Contact: Nuria Maspoch Clemente; Phone Number: +34 634 64 34 96; Email: maspochnuria@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gait training with exoskeleton; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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
Number and type of device-related Adverse Events	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.	From baseline to follow-up (up to 2 weeks after end of intervention)
Time taken to don/doff the device	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.	Up to 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gross Motor Function Measure-88	The Gross Motor Function Measure-88 (GMFM-88) is a standardized observational instrument designed to assess changes in gross motor function in children with motor impairments. It consists of 88 items grouped into five dimensions: lying and rolling, sitting, crawling and kneeling, standing, and walking/running/jumping. Each item is scored on a 4-point ordinal scale, with higher scores indicating better gross motor performance.	At baseline (day 0) and post-training (up to 4 weeks)
Motor Function Measure-20	The Motor Function Measure-20 (MFM-20) is a validated scale used to assess motor function in children with neuromuscular disorders. It evaluates functional abilities across three domains: standing position and transfers, axial and proximal motor function, and distal motor function. The scale consists of 20 items scored on a 4-point ordinal scale, with higher scores reflecting better motor performance.	At baseline (day 0) and post-training (up to 4 weeks)
Modified Ashworth Scale (MAS)	The Modified Ashworth Scale (MAS) measures spasticity in patients with lesions to the central nervous system. The scale assigns a grade of spasticity from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension).	At selection, baseline and post-training (up to 4 weeks)
Lower extremity muscle strength	The Daniels Muscle Testing scale will be used to measure the strength of muscles in the lower extremities. Scores range from 0 (absence of muscle activity) to 5 (normal muscle activity)	At baseline (day 0) and post-training (up to 4 weeks)
10-Meter Walk Test (10MWT)	The 10-Meter Walk Test (10MWT) measures the time a person needs to walk 10 meters. This test will be performed in the pre-post evaluations without the device to assess the change in the walking function after the training.	At baseline (day 0) and post-training (up to 4 weeks)
2-Minute Walk Test (2MWT)	The 2-Minute Walk Test (2MWT) measures the distance a person can walk in 2 minutes. This test will be assessed at baseline and at the end of the gait training program without the device to assess the change in the walking function after the training	At baseline (day 0) and post-training (up to 4 weeks)
Pediatric Balance Scale (PBS)	The Pediatric Balance Scale (PBS) is a standardized clinical assessment used to evaluate functional balance in children. Adapted from the Berg Balance Scale, it consists of 14 tasks commonly performed in everyday activities, such as sitting, standing, reaching, turning, and transferring. Each item is scored on a 5-point scale from 0 to 4, with higher scores indicating better balance performance.	At baseline and post-training (up to 4 weeks)
Location and level of pain - Faces Pain Scale-Revised	The Faces Pain Scale-Revised (FPS-R) is a self-report instrument used to assess pain intensity in children. The scale presents a series of faces representing increasing levels of pain intensity, allowing participants to select the face that best matches their pain experience. Pain location is additionally recorded based on the participant's report. Higher scores indicate greater pain intensity.	From baseline to post-training (up to 4 weeks)
OMNI Rating of Perceived Exertion	The OMNI Rating of Perceived Exertion Scale is a validated self-report measure used to assess perceived physical effort during exercise in pediatric populations. The scale combines numerical ratings with verbal descriptors and pictorial representations to help children quantify their level of exertion during physical activity. Higher scores indicate greater perceived exertion.	From baseline to post-training (up to 4 weeks)
Functional Independence Measure for Children (WeeFIM)	The Functional Independence Measure for Children (WeeFIM) is a standardized instrument used to assess functional independence in children. It evaluates performance in self-care, mobility, and cognition through 18 items scored on a 7-level scale, where 1 indicates total assistance and 7 indicates complete independence. Higher scores reflect greater functional independence in activities of daily living.	At baseline and post-training (up to 4 weeks)
Self-perceived impact on general health status	Participants' perceptions of the impact on their general health will be evaluated by the completion of a self-report questionnaire on the perceived impact on general health. This questionnaire has been designed by the researchers and intends to identify to what extent participants feel that the ABLE Kids contributed to a change in their health. The questionnaire covers 7 categories (cardiovascular system, musculoskeletal pain, neuropathic pain, bladder and bowel, skin, spasticity, and sleep quality) using a 7-point Likert scale to assess the change.	At post-training (up to 4 weeks)
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) score	The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) is a 12-item outcome measure that assesses user satisfaction with two components (Device and Services) using a 5-point scale ranging from 1 (not satisfied) to 5 (very satisfied). Only the 8 items referred to the device will be evaluated from participants and the whole 12 items from the therapists to measure user satisfaction with the ABLE Kids after the training program experience	At post-training (up to 4 weeks)
EuroQol 5 Dimensions Youth - 5 Levels (EQ-5D-Y-5L)	The EQ-5D-Y-5L is a standardized self-reported instrument used to assess health-related quality of life in children and adolescents. It evaluates five dimensions: mobility, looking after myself, doing usual activities, having pain or discomfort, and feeling worried, sad, or unhappy. Each dimension is rated on a 5-level scale ranging from "no problems" to "extreme problems." The instrument also includes a EuroQol Visual Analogue Scale (EQ VAS) for the participant's overall perception of their health status.	At baseline and post-training (up to 4 weeks)

Collaborators and Investigators

• Sponsor: ABLE Human Motion S.L.
• Collaborators: Som·hi Rehab

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 30, 2026
• First Submitted That Met QC Criteria: July 30, 2026
• First Posted (Actual): August 4, 2026

Study Record Updates

• Last Update Posted (Actual): August 27, 2026
• Last Update Submitted That Met QC Criteria: August 25, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: gait training; wearable exoskeleton; lower-limb exoskeleton
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Manifestations; Wounds and Injuries; Pathologic Processes; Congenital Abnormalities; Craniocerebral Trauma; Trauma, Nervous System; Brain Damage, Chronic; Spinal Cord Diseases; Nervous System Malformations; Neural Tube Defects; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Brain Injuries; Cerebral Palsy; Muscle Weakness; Spinal Cord Injuries; Spinal Dysraphism; Neuromuscular Diseases
• Other Study ID Numbers: ABLEkidsSP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No