Soft Robotics for Infants With Cerebral Palsy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: Soft Wearable Robotic Knee System

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Shatin, Hong Kong
    • Recruiting
    • Department of Biomedical Engineering, The Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

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: Soft Wearable Robotic Knee System; 30 minutes gait training wearing the Soft Wearable Robotic Knee System	Device: Soft Wearable Robotic Knee System; Power assistance will be provided from the motor to the knee joint

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Raymond Tong, PhD, Department of Biomedical Engineering, The Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2021
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 12, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Actual): October 21, 2022
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 2021.171

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