Soft Robotics for Infants With Cerebral Palsy

NCT05580497 | Unknown

• 1 other identifier: 2021.171
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 6-Minute-Walk Test

  Within one month after the last training session

• 10-Meter-Walk Test

  Within one month after the last training session

• Timed Up and Go test

  Within one month after the last training session

• Five Times Sit to Stand Test

  Within one month after the last training session

• Berg Balance Scale

  Within one month after the last training session

Study Arms (1)

Soft Wearable Robotic Knee System

EXPERIMENTAL

30 minutes gait training wearing the Soft Wearable Robotic Knee System

Device: Soft Wearable Robotic Knee System

Interventions

Soft Wearable Robotic Knee System DEVICE

Power assistance will be provided from the motor to the knee joint

Soft Wearable Robotic Knee System

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Biomedical Engineering, The Chinese University of Hong Kong

Shatin, Hong Kong

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Raymond Tong, PhD

  Department of Biomedical Engineering, The Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raymond Tong, PhD

CONTACT

+852 3943 8454; kytong@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 14, 2022
• Study Start: July 8, 2021
• Primary Completion: May 1, 2024
• Study Completion: August 1, 2024
• Last Updated: October 21, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)