Vibration Intervention to Improve Bone and Muscle in Children With Cerebral Palsy
Mechanical Intervention in Children With Cerebral Palsy
2 other identifiers
interventional
34
1 country
1
Brief Summary
Cerebral palsy is a group of disorders characterized by lack of coordination in the muscles, loss of movement, and speech disturbances. These disorders are caused by injuries to the brain that occur during fetal development or near the time of birth. The purpose of this study is to determine the effects of high frequency, low magnitude vibration on bone and muscle in children with cerebral palsy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2004
Typical duration for phase_2
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
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 21, 2006
CompletedFirst Posted
Study publicly available on registry
February 23, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedJanuary 10, 2024
January 1, 2024
February 21, 2006
January 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Vertebral bone density
Measured at Month 12
Tibia bone density
Measured at Month 12
Tibia cross-sectional area
Measured at Month 12
Secondary Outcomes (2)
Calf muscle strength
Measured at Month 12
Balance test
Measured at Month 12
Study Arms (2)
Vibration
EXPERIMENTALHigh frequency, low magnitude vibration at 30 Hz, 10 min/day using vibrating platform from Juvent Medical Inc.
Standing
ACTIVE COMPARATORStanding 10 min/day
Interventions
High frequency, low magnitude vibration at 30 Hz, 10 min/day using vibrating platform from Juvent Medical Inc.
Eligibility Criteria
You may qualify if:
- Diagnosis of cerebral palsy
- Low vertebral bone density
- Able to stand for 10 minutes with handheld support
- Parent or guardian willing to provide informed consent
You may not qualify if:
- Surgery, casting, or receipt of botulinum toxin in the 12 months prior to study entry
- Planned surgery, casting, or receipt of botulinum toxin in the 12 months after study entry
- Metal rods or plates in tibia or lumbar spine
- Severe scoliosis (greater than 20 degrees) or bowing of tibia
- Medical condition other than cerebral palsy affecting bone or muscle
- Require corticosteroids or seizure medication (phenytoin)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tishya A.L. Wren, PhD
Children's Orthopaedic Center, Children's Hospital Los Angeles, and Departments of Orthopaedics and Radiology, Keck School of Medicine, Department of Biomedical Engineering, School of Engineering, University of Southern California
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 21, 2006
First Posted
February 23, 2006
Study Start
September 1, 2004
Study Completion
September 1, 2007
Last Updated
January 10, 2024
Record last verified: 2024-01