NCT00629070

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 5, 2008

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2010

Completed
Last Updated

May 17, 2018

Status Verified

May 1, 2018

Enrollment Period

1.9 years

First QC Date

February 25, 2008

Last Update Submit

May 14, 2018

Conditions

Cerebral Palsy

Keywords

cerebral palsymuscle strengthmuscle architectureultrasoundrehabilitationrectus femorisquadriceps muscle

Outcome Measures

Primary Outcomes (1)

  • Muscle thickness

    before and after intervention

Secondary Outcomes (3)

  • Fascicle length

    before and after intervention

  • Muscle strength (peak torque)

    before and after intervention

  • Muscle power

    before and after intervention

Study Arms (2)

ST

EXPERIMENTAL

Traditional strength training

Other: Traditional strength training

VT

EXPERIMENTAL

Velocity-enhanced training

Other: Velocity-enhanced training

Interventions

Traditional strength trainingOTHER

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

ST
Velocity-enhanced trainingOTHER

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.

VT

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of cerebral palsy
  • Gross motor function classification system levels I, II, or III
  • Ages 7 to 17

You may not qualify if:

  • Orthopedic or neurosurgery within the past year
  • Botulinum toxin injections within the 4 months prior to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neuromuscular Assessment Laboratory

Charleston, South Carolina, 29414, United States

Location

Related Publications (5)

  • 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). 2007 Jul;22(6):718-24. doi: 10.1016/j.clinbiomech.2007.03.004. Epub 2007 May 1.

    PMID: 17475377BACKGROUND

  • 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.

    PMID: 12005316BACKGROUND

  • 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.

    PMID: 7672470BACKGROUND

  • Moreau NG, Li L, Geaghan JP, Damiano DL. Contributors to fatigue resistance of the hamstrings and quadriceps in cerebral palsy. Clin Biomech (Bristol). 2009 May;24(4):355-60. doi: 10.1016/j.clinbiomech.2009.01.012. Epub 2009 Mar 5.

    PMID: 19264384BACKGROUND

  • 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.

    PMID: 19459913BACKGROUND

Related Links

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Noelle G Moreau, PhD, PT

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2008

First Posted

March 5, 2008

Study Start

January 1, 2009

Primary Completion

December 13, 2010

Study Completion

December 13, 2010

Last Updated

May 17, 2018

Record last verified: 2018-05

Locations

US(1)