The Effect of Robot-assisted Gait Training on Gait Ability in Children With Cerebral Palsy Through Changing Gait Speed
1 other identifier
interventional
39
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2021
CompletedFirst Posted
Study publicly available on registry
June 1, 2021
CompletedStudy Start
First participant enrolled
June 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2021
CompletedJune 21, 2021
June 1, 2021
3 months
May 26, 2021
June 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Change from baseline gait ability at 6 weeks
Study Arms (3)
Robot-assisted gait training with walking speed of 0.5km/h
EXPERIMENTALRobot-assisted gait training with walking speed of 0.8km/h
EXPERIMENTALRobot-assisted gait training with walking speed of 1.1km/h
EXPERIMENTALInterventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pajucity convalescent Hospital
Paju, 10915, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sun-Geon Park, Ph.D candidate
The Wells Neuro Pain Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 26, 2021
First Posted
June 1, 2021
Study Start
June 18, 2021
Primary Completion
September 30, 2021
Study Completion
November 30, 2021
Last Updated
June 21, 2021
Record last verified: 2021-06