Effect of Botox and Vibration on Bone in Children With Cerebral Palsy
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|ClinicalTrials.gov Identifier: NCT01803464|
Recruitment Status : Completed
First Posted : March 4, 2013
Last Update Posted : September 11, 2015
|Condition or disease||Intervention/treatment|
|Cerebral Palsy Muscle Spasticity||Other: Botox plus low-magnitude vibration Drug: Botox|
The investigators have been working with children diagnosed with cerebral palsy (CP) for the past 10 years. The investigators have found that bone structure is markedly underdeveloped and bone strength is severely compromised in children with CP. Also, an increased fracture rate has been observed in the lower extremity bones of children with CP. There is evidence that Botox, which is used to treat spasticity in CP, can improve motor function; however the effect of Botox on human bone is unknown. There is also evidence that low intensity vibration treatment can improve bone mass and bone structure. The overall goal of this current research study is to investigate the effect and mechanism of action of Botox and vibration on bone in children with CP. The investigators will also examine the effect of Botox on muscle volume.
A total of 36 participants will participate in this study. The investigators will assess bone structure and muscle volume using MRI. The investigators will assess bone mass using DXA.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Botox and Vibration on Bone in Children With Cerebral Palsy|
|Study Start Date :||March 2012|
|Primary Completion Date :||February 2015|
|Study Completion Date :||February 2015|
Experimental: Botox plus low-magnitude vibration
Children with cerebral palsy who are recommended for and scheduled to receive Botox treatment will randomized to also receive vibration treatment. Children will be asked to stand on a vibration plate 10 minutes per day for 6 months.
Other: Botox plus low-magnitude vibration
Half of the children who receive Botox treatment will be randomly assigned to receive a high-frequency, low magnitude vibration treatment. The other half of the children who receive Botox treatment and are randomly assigned to the Botox-only group will be offered the vibration treatment at the end of the study.
Other Name: Drug plus device
Children with cerebral palsy who are recommended for and scheduled to receive Botox treatment will randomized to serve as a Botox-only group.
Children will not receive vibration treatment. Children in the Botox-only group will be offered vibration treatment at the end of the study.
No Intervention: Cerebral palsy control
Children with cerebral palsy who are recommended for but decline Botox treatment will serve as controls.
No Intervention: Typically developing control
Typically developing children without cerebral palsy will serve as controls.
- Bone structure [ Time Frame: Baseline and 6 months ]MRI will be used to assess bone structure at baseline and 6 months post baseline.
- Bone mass [ Time Frame: Baseline and 6 months ]Dual-energy X-ray absorptiometry will be used to assess bone mass at baseline and 6 months post baseline.
- Serum [ Time Frame: Baseline, 1 month, and 6 months ]Serum will be used to assess bone turnover at baseline and 1 month and 6 months post baseline.
- Muscle volume [ Time Frame: Baseline and 6 months ]MRI will be used to assess muscle volume at baseline and 6 months post baseline.
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): NCT01803464
|United States, Delaware|
|University of Delaware|
|Newark, Delaware, United States, 19716|
|Alfred I. duPont Hospital for Children, Nemours|
|Wilmington, Delaware, United States, 19899|
|Principal Investigator:||Christopher Modlesky, PhD||University of Delaware|
|Principal Investigator:||Freeman Miller, MD||Nemours/Alfred I duPont Hospital for Children|