N/A
N=29
Effect of Botox and Vibration on Bone in Children With Cerebral Palsy
Cerebral Palsy · Muscle Spasticity
Bottom Line
View on ClinicalTrials.gov: NCT01803464 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: Bone Structure — 10.4; 7.6; 6.7; 9.0 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Low-magnitude vibration (Device); Botox (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- University of Delaware
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bone Structure |
10.4; 7.6; 6.7; 9.0 | — |
| SECONDARY Muscle Volume |
9.5; 10.9; 5.1; 3.9 | — |
| SECONDARY Bone Mass |
8.1; 3.2; 4.2; 3.1 | — |
Summary
Cerebral palsy (CP) is a neuromuscular disorder that affects approximately 800,000 individuals in the U.S. An estimated 70-80% of these individuals have spasticity which affects ambulation and requires management. Therefore, the treatment of spasticity is a primary goal of interventions for children with CP. One treatment widely used to reduce spasticity is Botox because of its ability to temporarily paralyze a muscle. However, no studies have determined the effect of Botox treatment on bone in humans. Also, a low magnitude vibration treatment has been shown to improve bone structure in the lower extremity bones of children with CP. The aims of this study are: 1) to determine the effect of Botox treatment in conjunction with a daily vibration treatment on bone mass and bone structure in children with spastic CP, and 2) to identify the mechanism that underlies the effect of Botox and vibration on bone.
Eligibility Criteria
Inclusion (Children with CP):
- Have spastic CP
- Between 2-12 years of age
- Recommended for Botox treatment by their physician as part of their clinical care. Those who accept Botox treatment and those who do not accept Botox treatment are both eligible for the study.
- A score of 1-4 on the gross motor function classification scale (GMFCS)
Exclusion (Children with CP):
- Botox treatment in the lower extremities within the last year
- Metal rods in both legs
Inclusion (Typically developing children):
- Between 2 and 12 years of age.
- Match a child with CP for sex, age and race.
Exclusion(Typically developing children):
- Neurological disorder
- Surgery in the lower extremities within the last year.
- Chronic medication use
Data sourced from ClinicalTrials.gov (NCT01803464). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.