- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00629070
Quadriceps Muscle Plasticity in Children With Cerebral Palsy
May 14, 2018 updated by: Medical University of South Carolina
In Vivo Assessment of Quadriceps Muscle Plasticity in Children With Cerebral Palsy
Our primary aim is to determine whether and how muscle architecture of the quadriceps muscles in cerebral palsy (CP) adapts to two separate training programs: traditional strength training (ST) vs. velocity-enhanced training (VT).
For the ST group, we hypothesize that muscle size will increase in conjunction with strength.
For the VT group, in addition to the above, we hypothesize that fiber length will increase with measures of muscle power.
We also hypothesize that walking velocity will improve in both groups but that knee motion and step length will improve only with VT.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Cerebral palsy (CP) is the most common physical disability originating in childhood, occurring in 2-3 per 1,000 live births.
Although the primary deficit in CP is injury to the brain, secondary impairments affecting muscle function such as weakness, contractures, and spasticity are often far more debilitating and lead to worsening disability throughout the lifespan.
Some have suggested that these muscle changes in CP may be irreversible; however, it is now known that muscles are one of the most 'plastic' tissues in the body.
In fact, recent evidence suggests that gross muscle hypertrophy and architectural changes within muscle fibers can occur as early as 3-5 weeks after resistance training in healthy adults.
It is also unknown how effectively muscles in CP can adapt to training stimuli that target specific muscle architectural parameters, such as fascicle length and cross-sectional area.
These parameters have been observed to be decreased in CP, suggesting loss of sarcomeres in-series (fiber shortening) and in-parallel (muscle atrophy).
We propose here that specific training-induced muscle architectural adaptations can occur in CP, leading to improved motor function.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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South Carolina
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Charleston, South Carolina, United States, 29414
- Neuromuscular Assessment Laboratory
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of cerebral palsy
- Gross motor function classification system levels I, II, or III
- Ages 7 to 17
Exclusion Criteria:
- Orthopedic or neurosurgery within the past year
- Botulinum toxin injections within the 4 months prior to the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: ST
Traditional strength training
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Performed 3 x week for 8 weeks on an isokinetic dynamometer (knee extension exercise)at 30 degrees/second; 6 sets of 5 maximum-effort concentric actions
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Experimental: VT
Velocity-enhanced training
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Performed 3 x week for 8 weeks on an isokinetic dynamometer (knee extension exercise).
Subjects will perform 2 sets of 5 concentric exertions at 30°/second.
The following 4 sets of 5 repetitions will be performed at a faster speed, starting at 60° /second.
The velocity will be increased weekly in 15° /second increments up to a maximum of 120°/second.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Muscle thickness
Time Frame: before and after intervention
|
before and after intervention
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Fascicle length
Time Frame: before and after intervention
|
before and after intervention
|
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Muscle strength (peak torque)
Time Frame: before and after intervention
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before and after intervention
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Muscle power
Time Frame: before and after intervention
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before and after intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Noelle G Moreau, PhD, PT, Medical University of South Carolina
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mohagheghi AA, Khan T, Meadows TH, Giannikas K, Baltzopoulos V, Maganaris CN. Differences in gastrocnemius muscle architecture between the paretic and non-paretic legs in children with hemiplegic cerebral palsy. Clin Biomech (Bristol, Avon). 2007 Jul;22(6):718-24. doi: 10.1016/j.clinbiomech.2007.03.004. Epub 2007 May 1.
- Shortland AP, Harris CA, Gough M, Robinson RO. Architecture of the medial gastrocnemius in children with spastic diplegia. Dev Med Child Neurol. 2002 Mar;44(3):158-63. doi: 10.1017/s0012162201001864.
- Damiano DL, Vaughan CL, Abel MF. Muscle response to heavy resistance exercise in children with spastic cerebral palsy. Dev Med Child Neurol. 1995 Aug;37(8):731-9. doi: 10.1111/j.1469-8749.1995.tb15019.x.
- Moreau NG, Li L, Geaghan JP, Damiano DL. Contributors to fatigue resistance of the hamstrings and quadriceps in cerebral palsy. Clin Biomech (Bristol, Avon). 2009 May;24(4):355-60. doi: 10.1016/j.clinbiomech.2009.01.012. Epub 2009 Mar 5.
- Moreau NG, Teefey SA, Damiano DL. In vivo muscle architecture and size of the rectus femoris and vastus lateralis in children and adolescents with cerebral palsy. Dev Med Child Neurol. 2009 Oct;51(10):800-6. doi: 10.1111/j.1469-8749.2009.03307.x. Epub 2009 Apr 21.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2009
Primary Completion (Actual)
December 13, 2010
Study Completion (Actual)
December 13, 2010
Study Registration Dates
First Submitted
February 25, 2008
First Submitted That Met QC Criteria
February 25, 2008
First Posted (Estimate)
March 5, 2008
Study Record Updates
Last Update Posted (Actual)
May 17, 2018
Last Update Submitted That Met QC Criteria
May 14, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PDS 087657
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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