Back to resultsSoft Robotics for Infants With Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Soft Wearable Robotic Knee System
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy
Eligibility Criteria
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.
Sites / Locations
- Department of Biomedical Engineering, The Chinese University of Hong KongRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Soft Wearable Robotic Knee System
Arm Description
30 minutes gait training wearing the Soft Wearable Robotic Knee System
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
10-Meter-Walk Test
It is a performance measure used to assess walking speed in meters per second over a short distance.
Timed Up and Go test
It is used to determine fall risk and measure the progress of balance, sit to stand and walking.
Five Times Sit to Stand Test
It is used to assess functional lower extremity strength, transitional movements, balance, and fall risk.
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.
Full Information
NCT ID
NCT05580497
First Posted
October 12, 2022
Last Updated
October 19, 2022
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05580497
Brief Title
Soft Robotics for Infants With Cerebral Palsy
Official Title
Soft Robotics for Improved Standing and Walking in Infants With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Soft Wearable Robotic Knee System
Arm Type
Experimental
Arm Description
30 minutes gait training wearing the Soft Wearable Robotic Knee System
Intervention Type
Device
Intervention Name(s)
Soft Wearable Robotic Knee System
Intervention Description
Power assistance will be provided from the motor to the knee joint
Primary Outcome Measure Information:
Title
Gross Motor Function Classification System
Description
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.
Time Frame
Within one month after the last training session
Secondary Outcome Measure Information:
Title
6-Minute-Walk Test
Description
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.
Time Frame
Within one month after the last training session
Title
10-Meter-Walk Test
Description
It is a performance measure used to assess walking speed in meters per second over a short distance.
Time Frame
Within one month after the last training session
Title
Timed Up and Go test
Description
It is used to determine fall risk and measure the progress of balance, sit to stand and walking.
Time Frame
Within one month after the last training session
Title
Five Times Sit to Stand Test
Description
It is used to assess functional lower extremity strength, transitional movements, balance, and fall risk.
Time Frame
Within one month after the last training session
Title
Berg Balance Scale
Description
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.
Time Frame
Within one month after the last training session
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raymond Tong, PhD
Phone
+852 3943 8454
Email
kytong@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Tong, PhD
Organizational Affiliation
Department of Biomedical Engineering, The Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Biomedical Engineering, The Chinese University of Hong Kong
City
Shatin
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymond Tong, PhD
Phone
+852 3943 8454
Email
kytong@cuhk.edu.hk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Soft Robotics for Infants With Cerebral Palsy
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