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Quadriceps Muscle Plasticity in Children With Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT00629070
Recruitment Status : Unknown
Verified July 2010 by Medical University of South Carolina.
Recruitment status was:  Recruiting
First Posted : March 5, 2008
Last Update Posted : August 3, 2010
Sponsor:
Information provided by:
Medical University of South Carolina

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Other: Traditional strength training Other: Velocity-enhanced training Phase 2

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: In Vivo Assessment of Quadriceps Muscle Plasticity in Children With Cerebral Palsy
Study Start Date : January 2009
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : May 2011

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U.S. FDA Resources

Arm Intervention/treatment
Experimental: ST
Traditional strength training
Other: Traditional strength training
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
Experimental: VT
Velocity-enhanced training
Other: Velocity-enhanced training
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.



Primary Outcome Measures :
  1. Muscle thickness [ Time Frame: before and after intervention ]

Secondary Outcome Measures :
  1. Fascicle length [ Time Frame: before and after intervention ]
  2. Muscle strength (peak torque) [ Time Frame: before and after intervention ]
  3. Muscle power [ Time Frame: before and after intervention ]


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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00629070


Contacts
Contact: Noelle G Moreau, PhD, PT 843-792-4071 moreau@musc.edu

Locations
United States, South Carolina
Neuromuscular Assessment Laboratory Recruiting
Charleston, South Carolina, United States, 29414
Contact: Noelle G Moreau, PhD, PT    843-792-4071    moreau@musc.edu   
Principal Investigator: Noelle G Moreau, PhD, PT         
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Noelle G Moreau, PhD, PT Medical University of South Carolina

Publications:
Responsible Party: Noelle G. Moreau / Assistant Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00629070     History of Changes
Other Study ID Numbers: PDS 087657
First Posted: March 5, 2008    Key Record Dates
Last Update Posted: August 3, 2010
Last Verified: July 2010

Keywords provided by Medical University of South Carolina:
cerebral palsy
muscle strength
muscle architecture
ultrasound
rehabilitation
rectus femoris
quadriceps muscle

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases