Soft Robotics for Infants With Cerebral Palsy

Not Applicable

Recruiting

• Conditions: Cerebral Palsy
• Interventions: Device: Soft Wearable Robotic Knee System

• Registration Number: NCT05580497
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-08
• Status Verified: 2022-10
• Study First Submitted: 2022-10-12
• Study First Submitted QC: 2022-10-12
• Study First Posted: 2022-10-14
• Last Update Submitted: 2022-10-19
• Last Update Posted: 2022-10-21
• Primary Completion: 2024-05
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

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Exclusion Criteria

• unhealed skin lesions in the lower limbs;
• aggressive or self-harming behaviors;
• severe cognitive impairment.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Soft Wearable Robotic Knee System	Soft Wearable Robotic Knee System	30 minutes gait training wearing the Soft Wearable Robotic Knee System

Primary Outcome Measures

Name	Time	Method
Gross Motor Function Classification System	Within one month after the last training session	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.

Secondary Outcome Measures

Name	Time	Method
Five Times Sit to Stand Test	Within one month after the last training session	It is used to assess functional lower extremity strength, transitional movements, balance, and fall risk.
6-Minute-Walk Test	Within one month after the last training session	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.
Berg Balance Scale	Within one month after the last training session	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.
10-Meter-Walk Test	Within one month after the last training session	It is a performance measure used to assess walking speed in meters per second over a short distance.
Timed Up and Go test	Within one month after the last training session	It is used to determine fall risk and measure the progress of balance, sit to stand and walking.

Trial Locations

Locations (1)

Department of Biomedical Engineering, The Chinese University of Hong Kong; 🇭🇰 Shatin, Hong Kong