Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00295295
Status:
COMPLETED
Last Update Posted:
2024-01-10
First Post:
2006-02-21
Brief Title:
Vibration Intervention to Improve Bone and Muscle in Children With Cerebral Palsy
Sponsor:
Childrens Hospital Los Angeles
Organization:
Childrens Hospital Los Angeles
Study Overview
Official Title:
Mechanical Intervention in Children With Cerebral Palsy
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R21AR051564 | NIH | None | httpsreporternihgovquickSearch1R21AR051564 |
| R21AR051564 | NIH | None | None |