Soft Robotics for Infants With Cerebral Palsy

Study Overview
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Brief Summary
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Children with spastic cerebral palsy suffer from significant weakness that contributes to abnormal posture and movement. It is thought that this arises due lack of frequency sufficient tension to encourage normal muscular growth underlying the need for early intervention to encourage walking. The failure of muscle growth to keep pace with bone growth is most evident in the bi-articular muscles and contributes to joint contractures and gait abnormalities such as toe-walking and flexed-knee gait. Recently, our research team has developed a novel, lightweight (0.2kg at knee joint) and portable (energetically autonomous) Soft Wearable Robotic Knee System that can provide active powered knee assistance and synchronized proprioceptive feedback for the gait training of stroke patients' standing and walking.

Official Title
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Soft Robotics for Improved Standing and Walking in Infants With Cerebral Palsy

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Device: Soft Wearable Robotic Knee System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: capable of understanding the proposed exercises; aged 2 to 15 years; maximum weight 75 kg; children with no deformations that could prevent the use of the exoskeleton; Gross Motor Function Classification System (GMFCS) levels I to III; able to signal pain or discomfort. Exclusion Criteria: unhealed skin lesions in the lower limbs; aggressive or self-harming behaviors; severe cognitive impairment.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Soft Wearable Robotic Knee System<br>30 minutes gait training wearing the Soft Wearable Robotic Knee System | Device: Soft Wearable Robotic Knee System<br>* Power assistance will be provided from the motor to the knee joint<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gross Motor Function Classification System | It categorized the gross motor function of children and young people with cerebral palsy into 5 different levels. With level 1: Children walk at home, school, outdoors and in the community, while level 5: Children are transported in a manual wheelchair in all settings. | Within one month after the last training session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-Minute-Walk Test | It is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. | Within one month after the last training session | 
| 10-Meter-Walk Test | It is a performance measure used to assess walking speed in meters per second over a short distance. | Within one month after the last training session | 
| Timed Up and Go test | It is used to determine fall risk and measure the progress of balance, sit to stand and walking. | Within one month after the last training session | 
| Five Times Sit to Stand Test | It is used to assess functional lower extremity strength, transitional movements, balance, and fall risk. | Within one month after the last training session | 
| Berg Balance Scale | It is used to objectively determine a person's ability to safely balance during a series of predetermined tasks. It is a 14-item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. | Within one month after the last training session |