Back to resultsEffects of WALKBOT-G Robot-assisted Gait Training on Anticipatory Posture Adjustment Function and Balance With Cerebral Palsy
Primary Purpose
Cerebral Palsy, Spastic Hemiplegic Cerebral Palsy, Bilateral Spastic Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
robot-assisted gait training
conventional locomotion therapy
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy
Eligibility Criteria
Inclusion Criteria:
- Patients aged 6-12 years or younger who have not received botulinum toxin or surgery within 3 months before the study
- Patients diagnosed with Bilateral Spastic Cerebral Palsy
- Patients diagnosed with Spastic Hemiplegic Cerebral Palsy
Exclusion Criteria:
- Children who cannot understand and follow orders
- Children with stiffness in the lower limbs corresponding to the Modified Ashworth Scale (MAS)> 3
- Patients who wear a robot and walk without affecting contractures, deformities, or skin problems
- Infants with cardiovascular instability and mild scoliosis with a cobb's angle of 30 degrees or more
Sites / Locations
- Ez rehabilitation medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
robot-assisted gait training
conventional locomotion therapy
Arm Description
Outcomes
Primary Outcome Measures
muscle activation
Measure muscle activity of Sternocleidomastoid, C4 Cervical Paraspinals, L5 Paraspinals, Rectus Femoris, Medial Hamstring, and Soleus during functional reach test. Surface electromyograph(EMG)(Mini Wave Infinity Waterproof, Cometa Systems, Italy, 2017) was used to measure muscle activity, and analysis software(Myoresearch XP Master 1.07, Noraxon, USA, 2011) was used for EMG analysis. The sampling rate was set to 2000 Hz. The EMG raw data was quantified as 150 ms after applying full wave rectification, and filtering was performed in the range of 20 to 450 Hz using a digital band-pass filter (Lancosh FIR). do
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04884386
Brief Title
Effects of WALKBOT-G Robot-assisted Gait Training on Anticipatory Posture Adjustment Function and Balance With Cerebral Palsy
Official Title
Effects of WALKBOT-G Robot-assisted Gait Training on Anticipatory Posture Adjustment Function and Balance With Bilateral Spastic and Hemiplegic Cerebral Palsy: A Single-blind Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
June 12, 2021 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)
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
In children with cerebral palsy, the quality of walking decreases due to a decrease in the ability to control limbs, including walking, and coordination among various activities of daily living due to a decrease in functional independence and quality of life. Gait disorder is one of the important therapeutic goals of children with cerebral palsy, and recently robot-assisted gait training (RAGT) induces changes in brain plasticity, so it will help improve gross motor control and coordination control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic Hemiplegic Cerebral Palsy, Bilateral Spastic Cerebral Palsy, Gait Disorders, Neurologic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
robot-assisted gait training
Arm Type
Experimental
Arm Title
conventional locomotion therapy
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
robot-assisted gait training
Intervention Description
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
Behavioral
Intervention Name(s)
conventional locomotion therapy
Intervention Description
locomotion exercise, postural control training, balance training, electrotherapy
Primary Outcome Measure Information:
Title
muscle activation
Description
Measure muscle activity of Sternocleidomastoid, C4 Cervical Paraspinals, L5 Paraspinals, Rectus Femoris, Medial Hamstring, and Soleus during functional reach test. Surface electromyograph(EMG)(Mini Wave Infinity Waterproof, Cometa Systems, Italy, 2017) was used to measure muscle activity, and analysis software(Myoresearch XP Master 1.07, Noraxon, USA, 2011) was used for EMG analysis. The sampling rate was set to 2000 Hz. The EMG raw data was quantified as 150 ms after applying full wave rectification, and filtering was performed in the range of 20 to 450 Hz using a digital band-pass filter (Lancosh FIR). do
Time Frame
Change from baseline muscle activation at 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 6-12 years or younger who have not received botulinum toxin or surgery within 3 months before the study
Patients diagnosed with Bilateral Spastic Cerebral Palsy
Patients diagnosed with Spastic Hemiplegic Cerebral Palsy
Exclusion Criteria:
Children who cannot understand and follow orders
Children with stiffness in the lower limbs corresponding to the Modified Ashworth Scale (MAS)> 3
Patients who wear a robot and walk without affecting contractures, deformities, or skin problems
Infants with cardiovascular instability and mild scoliosis with a cobb's angle of 30 degrees or more
Facility Information:
Facility Name
Ez rehabilitation medical center
City
Yongin-si
ZIP/Postal Code
16943
Country
Korea, Republic of
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
Effects of WALKBOT-G Robot-assisted Gait Training on Anticipatory Posture Adjustment Function and Balance With Cerebral Palsy
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