Vibration Intervention to Improve Bone and Muscle in Children With Cerebral Palsy
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ClinicalTrials.gov Identifier: NCT00295295 |
Recruitment Status :
Completed
First Posted : February 23, 2006
Last Update Posted : June 20, 2013
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Condition or disease | Intervention/treatment | Phase |
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Cerebral Palsy | Device: High frequency, low magnitude vibration Other: Standing | Phase 2 |
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 : | Interventional (Clinical Trial) |
Enrollment : | 34 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Mechanical Intervention in Children With Cerebral Palsy |
Study Start Date : | September 2004 |
Actual Study Completion Date : | September 2007 |

Arm | Intervention/treatment |
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Experimental: Vibration
High frequency, low magnitude vibration at 30 Hz, 10 min/day using vibrating platform from Juvent Medical Inc.
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Device: High frequency, low magnitude vibration
High frequency, low magnitude vibration at 30 Hz, 10 min/day using vibrating platform from Juvent Medical Inc. |
Active Comparator: Standing
Standing 10 min/day
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Other: Standing
Standing 10 min/day |
- 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 ]
- 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

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Ages Eligible for Study: | 6 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00295295
United States, California | |
Children's Hospital Los Angeles | |
Los Angeles, California, United States, 90027 |
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 |
ClinicalTrials.gov Identifier: | NCT00295295 |
Other Study ID Numbers: |
1R21AR051564 ( U.S. NIH Grant/Contract ) R21AR051564 ( U.S. NIH Grant/Contract ) 1R21AR051564 ( U.S. NIH Grant/Contract ) |
First Posted: | February 23, 2006 Key Record Dates |
Last Update Posted: | June 20, 2013 |
Last Verified: | May 2013 |
vibration bone density |
Cerebral Palsy Nervous System Diseases Brain Damage, Chronic Brain Diseases Central Nervous System Diseases |