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.
Minors with gait impairments, ranging from mild to severe, resulting from neurological conditions or muscular weakness
Weight under 75 kg
Height between 1.0-1.5 m
Hip: maximum distance between greater trochanters of 35 cm
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%)
Single group
ABLE Kids
DeviceParticipants 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.
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.
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.
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
Distance walked
In each gait training session, the distance walked (in meters) with the device will be automatically measured and registered by the device
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)
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.
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.
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.
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ABLE Human Motion S.L.
Lead sponsor
Som·hi Rehab
Collaborator
