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Cerebral PalsyNCT01803464

Effect of Botox and Vibration on Bone in Children With Cerebral Palsy

A study testing Low-magnitude vibration and Botox in people with Cerebral Palsy and Muscle Spasticity, run by University of Delaware at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Cerebral Palsy, Muscle Spasticity
What is being tested?
Low-magnitude vibration and Botox
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
2 sitesUnited States
Study dates
Mar 2012to Feb 2015
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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)
  • Between 2 and 12 years of age.
  • Match a child with CP for sex, age and race.

Who cannot join

  • Botox treatment in the lower extremities within the last year
  • Metal rods in both legs
  • Neurological disorder
  • Surgery in the lower extremities within the last year.
  • Chronic medication use

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Delaware

    Newark, Delaware, 19716

  • Alfred I. duPont Hospital for Children, Nemours

    Wilmington, Delaware, 19899

Other trials in United States

About this study

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.

Read the detailed description

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 magnitude 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 dual-energy X-ray absorptiometry (DXA).

Being tested
Low-magnitude vibration, Botox
Keywords
Botox, Muscle strength
Medical subject headings
Cerebral Palsy, Muscle Spasticity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low-magnitude vibrationDevice

    Children will receive a daily low-magnitude vibration treatment.

  • BotoxDrug

    Children who are candidates to receive Botox as part of their standard of care.

Study groups in NCT01803464
Study groupRoleWhat they receive
Botox plus low-magnitude vibrationExperimentalCerebral palsy and Botox + vibration
Receives: Device: Low-magnitude vibration; Drug: Botox
BotoxExperimentalCerebral palsy and Botox
Receives: Drug: Botox
Cerebral palsy controlNo interventionCerebral palsy without treatment
Typically developing controlNo interventionTypically developing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bone Structure

    Change in cortical bone volume of the middle third of the tibia from baseline to 6 months, as measured by MRI.

    Measured: baseline to 6 months

Secondary outcomes (2)

  1. Muscle Volume

    Change in muscle volume of the midleg from baseline to 6 months, as measured by MRI

    Measured: baseline to 6 months

  2. Bone Mass

    Change in bone mineral content in the distal femur from baseline to 6 months, as measured by dual-energy X-ray absorptiometry (DXA)

    Measured: baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2013 (estimated)
  2. Study startMar 2012
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01803464
Sponsor's protocol ID
1R15HD071397-01
Other IDs
IRB # 115648-11, 1R15HD071397-01
Status last verified
Feb 2018
First submitted
27 Feb 2013
Last updated
20 Mar 2018
Data monitoring committee
Yes
Individual data sharing
Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.

Publications

  • Johnson DL, Miller F, Subramanian P, Modlesky CM. Adipose tissue infiltration of skeletal muscle in children with cerebral palsy. J Pediatr. 2009 May;154(5):715-20. doi: 10.1016/j.jpeds.2008.10.046. Epub 2008 Dec 25.

    PubMed 19111321

  • Modlesky CM, Subramanian P, Miller F. Underdeveloped trabecular bone microarchitecture is detected in children with cerebral palsy using high-resolution magnetic resonance imaging. Osteoporos Int. 2008 Feb;19(2):169-76. doi: 10.1007/s00198-007-0433-x. Epub 2007 Oct 26.

    PubMed 17962918

  • Rubin C, Turner AS, Muller R, Mittra E, McLeod K, Lin W, Qin YX. Quantity and quality of trabecular bone in the femur are enhanced by a strongly anabolic, noninvasive mechanical intervention. J Bone Miner Res. 2002 Feb;17(2):349-57. doi: 10.1359/jbmr.2002.17.2.349.

    PubMed 11811566

  • Judex S, Boyd S, Qin YX, Turner S, Ye K, Muller R, Rubin C. Adaptations of trabecular bone to low magnitude vibrations result in more uniform stress and strain under load. Ann Biomed Eng. 2003 Jan;31(1):12-20. doi: 10.1114/1.1535414.

    PubMed 12572652

  • Wren TA, Lee DC, Hara R, Rethlefsen SA, Kay RM, Dorey FJ, Gilsanz V. Effect of high-frequency, low-magnitude vibration on bone and muscle in children with cerebral palsy. J Pediatr Orthop. 2010 Oct-Nov;30(7):732-8. doi: 10.1097/BPO.0b013e3181efbabc.

    PubMed 20864862

  • Ward K, Alsop C, Caulton J, Rubin C, Adams J, Mughal Z. Low magnitude mechanical loading is osteogenic in children with disabling conditions. J Bone Miner Res. 2004 Mar;19(3):360-9. doi: 10.1359/JBMR.040129. Epub 2004 Jan 27.

    PubMed 15040823

  • Modlesky CM, Whitney DG, Singh H, Barbe MF, Kirby JT, Miller F. Underdevelopment of trabecular bone microarchitecture in the distal femur of nonambulatory children with cerebral palsy becomes more pronounced with distance from the growth plate. Osteoporos Int. 2015 Feb;26(2):505-12. doi: 10.1007/s00198-014-2873-4. Epub 2014 Sep 9.

    PubMed 25199575

  • Modlesky CM, Whitney DG, Carter PT, Allerton BM, Kirby JT, Miller F. The pattern of trabecular bone microarchitecture in the distal femur of typically developing children and its effect on processing of magnetic resonance images. Bone. 2014 Mar;60:1-7. doi: 10.1016/j.bone.2013.11.009. Epub 2013 Nov 20.

    PubMed 24269277

  • Singh H, Whitney DG, Knight CA, Miller F, Manal K, Kolm P, Modlesky CM. Site-Specific Transmission of a Floor-Based, High-Frequency, Low-Magnitude Vibration Stimulus in Children With Spastic Cerebral Palsy. Arch Phys Med Rehabil. 2016 Feb;97(2):218-23. doi: 10.1016/j.apmr.2015.08.434. Epub 2015 Sep 21.

    PubMed 26392035

Questions about this trial

What is this clinical trial studying?

A study testing Low-magnitude vibration and Botox in people with Cerebral Palsy and Muscle Spasticity, run by University of Delaware at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bone Structure (time frame: baseline to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01803464, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2018.

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