Trial · NCT01803464
Effect of Botox and Vibration on Bone in Children With Cerebral Palsy
NCT01803464, Not applicable, Completed, University of Delaware; results first posted 2018-03-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Botox and Vibration on Bone in Children With Cerebral Palsy. Trials, record NCT01803464. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01803464
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Botox and Vibration on Bone in Children With Cerebral Palsy
- NCT number
- NCT01803464
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 29 participants, actual
- Lead sponsor
- University of Delaware
- Conditions
- Cerebral Palsy, Muscle Spasticity
- Interventions
- Low-magnitude vibration, Botox
- First posted
- 2013-03-04
- Last updated
- 2018-03-20
- Results first posted
- 2018-03-20
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Bone Structure | baseline to 6 months | Change in cortical bone volume of the middle third of the tibia from baseline to 6 months, as measured by MRI. |
| Secondary | Muscle Volume | baseline to 6 months | Change in muscle volume of the midleg from baseline to 6 months, as measured by MRI |
| Secondary | Bone Mass | baseline to 6 months | Change in bone mineral content in the distal femur from baseline to 6 months, as measured by dual-energy X-ray absorptiometry (DXA) |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Bone Structure | baseline to 6 months | percent change | MEAN | |
| SECONDARY | Muscle Volume | baseline to 6 months | percent change | MEAN | |
| SECONDARY | Bone Mass | baseline to 6 months | percent change | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Bone Structure | Botox Plus Low-magnitude Vibration | 10.4 | Standard Deviation 8.6 | percent change | |
| Bone Structure | Botox | 7.6 | Standard Deviation 10.2 | percent change | |
| Bone Structure | Cerebral Palsy Control | 6.7 | Standard Deviation 4.7 | percent change | |
| Bone Structure | Typically Developing Control | 9.0 | Standard Deviation 4.4 | percent change | |
| Muscle Volume | Botox Plus Low-magnitude Vibration | 9.5 | Standard Deviation 13.5 | percent change | |
| Muscle Volume | Botox | 10.9 | Standard Deviation 14.2 | percent change | |
| Muscle Volume | Cerebral Palsy Control | 5.1 | Standard Deviation 7.4 | percent change | |
| Muscle Volume | Typically Developing Control | 3.9 | Standard Deviation 10.1 | percent change | |
| Bone Mass | Botox Plus Low-magnitude Vibration | 8.1 | Standard Deviation 4.3 | percent change | |
| Bone Mass | Botox | 3.2 | Standard Deviation 3.9 | percent change |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Botox Plus Low-magnitude Vibration | 5 | |
| Overall Study | STARTED | Botox | 4 | |
| Overall Study | STARTED | Cerebral Palsy Control | 10 | |
| Overall Study | STARTED | Typically Developing Control | 10 | |
| Overall Study | COMPLETED | Botox Plus Low-magnitude Vibration | 4 | |
| Overall Study | COMPLETED | Botox | 4 | |
| Overall Study | COMPLETED | Cerebral Palsy Control | 6 | |
| Overall Study | COMPLETED | Typically Developing Control | 10 | |
| Overall Study | NOT COMPLETED | Botox Plus Low-magnitude Vibration | 1 | |
| Overall Study | NOT COMPLETED | Botox | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Botox Plus Low-magnitude Vibration | 0 | 5 | 0 |
| other | Nausea | Gastrointestinal disorders | Botox | 0 | 4 | 0 |
| other | Nausea | Gastrointestinal disorders | Cerebral Palsy Control | 0 | 10 | 0 |
| other | Nausea | Gastrointestinal disorders | Typically Developing Control | 3 | 10 | 3 |
Source ClinicalTrials.gov
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Botox Plus Low-magnitude Vibration | ||
| Total, all-cause mortality | Botox | ||
| Total, all-cause mortality | Cerebral Palsy Control | ||
| Total, all-cause mortality | Typically Developing Control | ||
| Total, other adverse events | Botox Plus Low-magnitude Vibration | 0 | 5 |
| Total, other adverse events | Botox | 0 | 4 |
| Total, other adverse events | Cerebral Palsy Control | 0 | 10 |
| Total, other adverse events | Typically Developing Control | 3 | 10 |
| Total, serious adverse events | Botox Plus Low-magnitude Vibration | 0 | 5 |
| Total, serious adverse events | Botox | 0 | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers9
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R15HD071397 | Effect of botulinum toxin plus vibration on bone in children with cerebral palsy | MODLESKY, CHRISTOPHER M | UNIVERSITY OF DELAWARE | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2012 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01803464
GET https://conductscience.org/api/trials/v1/NCT01803464/registered