The Effect of Robot-assisted Gait Training on Gait Ability in Children With Cerebral Palsy Through Changing Gait Speed
Primary Purpose
Cerebral Palsy, Gait Disorders, Neurologic, Bilateral Spastic Cerebral Palsy
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Robot-assisted gait training (walking speed: 0.5km/h)
Robot-assisted gait training (walking speed: 0.8km/h)
Robot-assisted gait training (walking speed: 1.1km/h)
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy
Eligibility Criteria
Inclusion Criteria:
- Patients 4-12 years old diagnosed with cerebral palsy
- Children who have not received botulinum toxin treatment or surgery within 3 months
- Children in stage 2 of the gross motor function system
- Children who can express pain, fear, or discomfort on their own
Exclusion Criteria:
- Severe lower extremity contracture and fracture
- Bone instability
- Osteoporosis
- Severe bones grow disproportionately
- Unhealed skin lesions on the lower extremities (thromboembolic disease)
- Thromboembolic disease
- Cardiovascular instability
- Mild scoliosis with a Cobb's angle of more than 20 degrees
Sites / Locations
- Pajucity convalescent HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Robot-assisted gait training with walking speed of 0.5km/h
Robot-assisted gait training with walking speed of 0.8km/h
Robot-assisted gait training with walking speed of 1.1km/h
Arm Description
Outcomes
Primary Outcome Measures
Gait ability
Gait ability is evaluated using the Zebris FDM-Treadmill. When the participants walks on the treadmill, the foot pressure is recorded at a rate of 120 Hz. The input pressure signal is displayed as a 2D/3D graph including the center of pressure while standing or walking, and the spatiotemporal measurements are displayed.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04909151
Brief Title
The Effect of Robot-assisted Gait Training on Gait Ability in Children With Cerebral Palsy Through Changing Gait Speed
Official Title
The Effect of Robot-assisted Gait Training on Gait Ability in Children With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 18, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
November 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahmyook University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Robot-assisted gait training (RAGT) improves the gait ability of children with cerebral palsy, and can provide treatment plans and guidelines through changed records of various gait variables. There is a lack of concrete explanations or arguments for gait speed, weight support ratio, support force, joint angle, etc. that can be set in the RAGT system, and intervention intensity for an appropriate intervention program has not been presented. Therefore, in this study, we would like to suggest clinically effective interventions for children with cerebral palsy in the second stage of the gross motor function classification system (GMFCS) by identifying gait variables according to differences in gait speed during RAGT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Gait Disorders, Neurologic, Bilateral Spastic Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
39 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Robot-assisted gait training with walking speed of 0.5km/h
Arm Type
Experimental
Arm Title
Robot-assisted gait training with walking speed of 0.8km/h
Arm Type
Experimental
Arm Title
Robot-assisted gait training with walking speed of 1.1km/h
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Robot-assisted gait training (walking speed: 0.5km/h)
Intervention Description
Robot-assisted gait training RAGT, WALKBOT-G, is a walking training equipment that can reproduce natural motions by adjusting the leg length and adjusting the motion with the actuator of the ankle joint.
Intervention Type
Device
Intervention Name(s)
Robot-assisted gait training (walking speed: 0.8km/h)
Intervention Description
Robot-assisted gait training RAGT, WALKBOT-G, is a walking training equipment that can reproduce natural motions by adjusting the leg length and adjusting the motion with the actuator of the ankle joint.
Intervention Type
Device
Intervention Name(s)
Robot-assisted gait training (walking speed: 1.1km/h)
Intervention Description
Robot-assisted gait training RAGT, WALKBOT-G, is a walking training equipment that can reproduce natural motions by adjusting the leg length and adjusting the motion with the actuator of the ankle joint.
Primary Outcome Measure Information:
Title
Gait ability
Description
Gait ability is evaluated using the Zebris FDM-Treadmill. When the participants walks on the treadmill, the foot pressure is recorded at a rate of 120 Hz. The input pressure signal is displayed as a 2D/3D graph including the center of pressure while standing or walking, and the spatiotemporal measurements are displayed.
Time Frame
Change from baseline gait ability at 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients 4-12 years old diagnosed with cerebral palsy
Children who have not received botulinum toxin treatment or surgery within 3 months
Children in stage 2 of the gross motor function system
Children who can express pain, fear, or discomfort on their own
Exclusion Criteria:
Severe lower extremity contracture and fracture
Bone instability
Osteoporosis
Severe bones grow disproportionately
Unhealed skin lesions on the lower extremities (thromboembolic disease)
Thromboembolic disease
Cardiovascular instability
Mild scoliosis with a Cobb's angle of more than 20 degrees
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sun-Geon Park, Ph.D candidate
Phone
+82-10-6204-8377
Email
spring1056@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun-Geon Park, Ph.D candidate
Organizational Affiliation
The Wells Neuro Pain Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pajucity convalescent Hospital
City
Paju
ZIP/Postal Code
10915
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sun-Geon Park
Phone
+82-31-942-7500
Email
spring1056@naver.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
I plan to decide after the study is over.
Learn more about this trial
The Effect of Robot-assisted Gait Training on Gait Ability in Children With Cerebral Palsy Through Changing Gait Speed
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