Soft Robotics for Infants With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05580497
• Other study ID #: 2021.171
• Status: Recruiting
• Phase: N/A
• Start date: July 8, 2021
• Est. completion date: August 2024

Study information

• Verified date: October 2022
• Source: Chinese University of Hong Kong
• Contact: Raymond Tong, PhD
• Phone: +852 3943 8454
• Email: kytong[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Device:
• Soft Wearable Robotic Knee System
Power assistance will be provided from the motor to the knee joint

Locations

Country	Name	City	State
Hong Kong	Department of Biomedical Engineering, The Chinese University of Hong Kong	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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