Trial Outcomes & Findings for Effect of Botox and Vibration on Bone in Children With Cerebral Palsy (NCT NCT01803464)
NCT ID: NCT01803464
Last Updated: 2018-03-20
Results Overview
Change in cortical bone volume of the middle third of the tibia from baseline to 6 months, as measured by MRI.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
baseline to 6 months
Results posted on
2018-03-20
Participant Flow
62 children with spastic cerebral palsy eligible for botulinum toxin treatment and typically developing children were screened. 5 children did not meet the study criteria and 57 children were invited to participate in the study, of which 29 participated in the study.
Participant milestones
| Measure |
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.
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.
|
Botox
Children with cerebral palsy who are recommended for and scheduled to receive Botox treatment will randomized to serve as a Botox-only group.
Botox: Children will not receive vibration treatment. Children in the Botox-only group will be offered vibration treatment at the end of the study.
|
Cerebral Palsy Control
Children with cerebral palsy who are recommended for but decline Botox treatment will serve as controls.
|
Typically Developing Control
Typically developing children without cerebral palsy will serve as controls.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
10
|
10
|
|
Overall Study
COMPLETED
|
4
|
4
|
6
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
4
|
0
|
Reasons for withdrawal
| Measure |
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.
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.
|
Botox
Children with cerebral palsy who are recommended for and scheduled to receive Botox treatment will randomized to serve as a Botox-only group.
Botox: Children will not receive vibration treatment. Children in the Botox-only group will be offered vibration treatment at the end of the study.
|
Cerebral Palsy Control
Children with cerebral palsy who are recommended for but decline Botox treatment will serve as controls.
|
Typically Developing Control
Typically developing children without cerebral palsy will serve as controls.
|
|---|---|---|---|---|
|
Overall Study
Incomplete data
|
0
|
0
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Effect of Botox and Vibration on Bone in Children With Cerebral Palsy
Baseline characteristics by cohort
| Measure |
Botox Plus Low-magnitude Vibration
n=5 Participants
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.
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.
|
Botox
n=4 Participants
Children with cerebral palsy who are recommended for and scheduled to receive Botox treatment will randomized to serve as a Botox-only group.
Botox: Children will not receive vibration treatment. Children in the Botox-only group will be offered vibration treatment at the end of the study.
|
Cerebral Palsy Control
n=10 Participants
Children with cerebral palsy who are recommended for but decline Botox treatment will serve as controls.
|
Typically Developing Control
n=10 Participants
Typically developing children without cerebral palsy will serve as controls.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
7.73 years
STANDARD_DEVIATION 2.85 • n=5 Participants
|
8.50 years
STANDARD_DEVIATION 2.65 • n=7 Participants
|
7.61 years
STANDARD_DEVIATION 2.22 • n=5 Participants
|
8.71 years
STANDARD_DEVIATION 1.68 • n=4 Participants
|
8.13 years
STANDARD_DEVIATION 2.16 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
29 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: baseline to 6 monthsChange in cortical bone volume of the middle third of the tibia from baseline to 6 months, as measured by MRI.
Outcome measures
| Measure |
Botox Plus Low-magnitude Vibration
n=4 Participants
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.
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.
|
Botox
n=4 Participants
Children with cerebral palsy who are recommended for and scheduled to receive Botox treatment will randomized to serve as a Botox-only group.
Botox: Children will not receive vibration treatment. Children in the Botox-only group will be offered vibration treatment at the end of the study.
|
Cerebral Palsy Control
n=6 Participants
Children with cerebral palsy who are recommended for but decline Botox treatment will serve as controls.
|
Typically Developing Control
n=10 Participants
Typically developing children without cerebral palsy will serve as controls.
|
|---|---|---|---|---|
|
Bone Structure
|
10.4 percent change
Standard Deviation 8.6
|
7.6 percent change
Standard Deviation 10.2
|
6.7 percent change
Standard Deviation 4.7
|
9.0 percent change
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: baseline to 6 monthsChange in muscle volume of the midleg from baseline to 6 months, as measured by MRI
Outcome measures
| Measure |
Botox Plus Low-magnitude Vibration
n=4 Participants
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.
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.
|
Botox
n=4 Participants
Children with cerebral palsy who are recommended for and scheduled to receive Botox treatment will randomized to serve as a Botox-only group.
Botox: Children will not receive vibration treatment. Children in the Botox-only group will be offered vibration treatment at the end of the study.
|
Cerebral Palsy Control
n=6 Participants
Children with cerebral palsy who are recommended for but decline Botox treatment will serve as controls.
|
Typically Developing Control
n=10 Participants
Typically developing children without cerebral palsy will serve as controls.
|
|---|---|---|---|---|
|
Muscle Volume
|
9.5 percent change
Standard Deviation 13.5
|
10.9 percent change
Standard Deviation 14.2
|
5.1 percent change
Standard Deviation 7.4
|
3.9 percent change
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: baseline to 6 monthsChange in bone mineral content in the distal femur from baseline to 6 months, as measured by dual-energy X-ray absorptiometry (DXA)
Outcome measures
| Measure |
Botox Plus Low-magnitude Vibration
n=4 Participants
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.
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.
|
Botox
n=4 Participants
Children with cerebral palsy who are recommended for and scheduled to receive Botox treatment will randomized to serve as a Botox-only group.
Botox: Children will not receive vibration treatment. Children in the Botox-only group will be offered vibration treatment at the end of the study.
|
Cerebral Palsy Control
n=6 Participants
Children with cerebral palsy who are recommended for but decline Botox treatment will serve as controls.
|
Typically Developing Control
n=10 Participants
Typically developing children without cerebral palsy will serve as controls.
|
|---|---|---|---|---|
|
Bone Mass
|
8.1 percent change
Standard Deviation 4.3
|
3.2 percent change
Standard Deviation 3.9
|
4.2 percent change
Standard Deviation 2.5
|
3.1 percent change
Standard Deviation 3.9
|
Adverse Events
Botox Plus Low-magnitude Vibration
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Botox
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cerebral Palsy Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Typically Developing Control
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Botox Plus Low-magnitude Vibration
n=5 participants at risk
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.
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.
|
Botox
n=4 participants at risk
Children with cerebral palsy who are recommended for and scheduled to receive Botox treatment will randomized to serve as a Botox-only group.
Botox: Children will not receive vibration treatment. Children in the Botox-only group will be offered vibration treatment at the end of the study.
|
Cerebral Palsy Control
n=10 participants at risk
Children with cerebral palsy who are recommended for but decline Botox treatment will serve as controls.
|
Typically Developing Control
n=10 participants at risk
Typically developing children without cerebral palsy will serve as controls.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/10
|
30.0%
3/10 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place