Vibration Intervention to Improve Bone and Muscle in Children With Cerebral Palsy

Tracking Information
First Submitted Date ICMJE	February 21, 2006
First Posted Date ICMJE	February 23, 2006
Last Update Posted Date	June 20, 2013
Study Start Date ICMJE	September 2004
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: December 14, 2007)	Vertebral bone density [ Time Frame: Measured at Month 12 ]; Tibia bone density [ Time Frame: Measured at Month 12 ]; Tibia cross-sectional area [ Time Frame: Measured at Month 12 ]
Original Primary Outcome Measures ICMJE; (submitted: February 21, 2006)	Vertebral bone density; Tibia bone density; Tibia cross-sectional area
Change History	Complete list of historical versions of study NCT00295295 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 5, 2013)	Calf muscle strength [ Time Frame: Measured at Month 12 ]; Balance test [ Time Frame: Measured at Month 12 ]Clinical balance test used by California Children's Services, Los Angeles County Medical Therapy Units
Original Secondary Outcome Measures ICMJE; (submitted: February 21, 2006)	Calf muscle strength; Balance test
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Vibration Intervention to Improve Bone and Muscle in Children With Cerebral Palsy
Official Title ICMJE	Mechanical Intervention in Children With Cerebral Palsy
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.
Detailed Description	The extent of bone mass built up during childhood and adolescence is the most important determinant of osteoporosis later in life. Some disabled children, such as those with cerebral palsy, are particularly vulnerable to low bone mass accumulation due to decreased mobility and weight-bearing. These children also have poor muscle strength and control, which limits function and contributes to the lack of mechanical stimulation needed to build bone mass. The most common treatment for these children is physical therapy, which is time- and labor-intensive and may not be adequately available to them. Whole body vibration has shown promise as an alternative method for stimulating increases in bone mass and improvements in muscle. The purpose of this study is to evaluate the effects of high frequency, low magnitude vibration on bone and muscle in children with cerebral palsy. This intervention may be useful as a noninvasive, nonpharmacological treatment for low bone mass and poor muscle function in these children. This study will last 1 year. All participants will visit the hospital 3 times, at study entry and Months 6 and 12. At each visit, height and weight will be measured, muscle strength and balance will be tested, and bones and muscles in the spine and lower leg will be imaged with computed tomography (CT), a special x-ray machine. Participants will be randomly assigned to one of two groups. For this study, all participants will be asked to stand for 10 minutes every day for 1 year. For Group 1, a vibrating platform will be used for the 10-minute standing sessions during the first half of the study but not during the second half of the study. For Group 2, this will be reversed and the vibrating platform will not be used during the first half of the study but will be used during the second half of the study.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Cerebral Palsy
Intervention ICMJE	Device: High frequency, low magnitude vibration High frequency, low magnitude vibration at 30 Hz, 10 min/day using vibrating platform from Juvent Medical Inc.; Other: Standing Standing 10 min/day
Study Arms	Experimental: Vibration High frequency, low magnitude vibration at 30 Hz, 10 min/day using vibrating platform from Juvent Medical Inc. Intervention: Device: High frequency, low magnitude vibration; Active Comparator: Standing Standing 10 min/day Intervention: Other: Standing
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE; (submitted: February 21, 2006)	34
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	September 2007
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	Inclusion Criteria: 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 Exclusion Criteria: 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)
Sex/Gender	Sexes Eligible for Study: All
Ages	6 Years to 12 Years (Child)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00295295
Other Study ID Numbers ICMJE	1R21AR051564( U.S. NIH Grant/Contract ); R21AR051564 ( U.S. NIH Grant/Contract ); 1R21AR051564 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Children's Hospital Los Angeles
Collaborators ICMJE	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators ICMJE	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
PRS Account	Children's Hospital Los Angeles
Verification Date	May 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP