Cerebral PalsyNCT00629070
Quadriceps Muscle Plasticity in Children With Cerebral Palsy
A study testing Traditional strength training and Velocity-enhanced training in people with Cerebral Palsy, run by Medical University of South Carolina at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Traditional strength training and Velocity-enhanced training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to 13 Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of cerebral palsy
- Gross motor function classification system levels I, II, or III
- Ages 7 to 17
Who cannot join
- Orthopedic or neurosurgery within the past year
- Botulinum toxin injections within the 4 months prior to the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Neuromuscular Assessment Laboratory
Charleston, South Carolina, 29414
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Traditional strength training, Velocity-enhanced training
- Keywords
- cerebral palsy, muscle strength, muscle architecture, ultrasound, rehabilitation, rectus femoris, quadriceps muscle
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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.
| Study group | Role | What they receive |
|---|---|---|
| ST | Experimental | Traditional strength training Receives: Other: Traditional strength training |
| VT | Experimental | Velocity-enhanced training Receives: Other: Velocity-enhanced training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle thickness
Measured: before and after intervention
Secondary outcomes (3)
Fascicle length
Measured: before and after intervention
Muscle strength (peak torque)
Measured: before and after intervention
Muscle power
Measured: before and after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startJan 2009
- Primary completion13 Dec 2010
- Study completion13 Dec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noelle G Moreau, PhD, PT, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629070
- Sponsor's protocol ID
- PDS 087657
- Status last verified
- May 2018
- First submitted
- 25 Feb 2008
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- No
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). 2007 Jul;22(6):718-24. doi: 10.1016/j.clinbiomech.2007.03.004. Epub 2007 May 1.
PubMed 17475377Shortland 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.
PubMed 12005316Damiano 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.
PubMed 7672470Moreau 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.
PubMed 19264384Moreau 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.
PubMed 19459913
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Assessment of Quadriceps Muscle Plasticity in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT00629070
- Acronym / sponsor ID
- PDS 087657
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, muscle strength, muscle architecture, ultrasound, rehabilitation, rectus femoris, quadriceps muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Jan 2009 (actual)
- Primary completion
- 13 Dec 2010 (actual)
- Study completion
- 13 Dec 2010 (actual)
- First posted
- 5 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ST | Experimental | Other: Traditional strength trainingTraditional strength training |
| VT | Experimental | Other: Velocity-enhanced trainingVelocity-enhanced training |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosis of cerebral palsy
- Gross motor function classification system levels I, II, or III
- Ages 7 to 17
Key exclusion criteria (2 listed)
- Orthopedic or neurosurgery within the past year
- Botulinum toxin injections within the 4 months prior to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional strength trainingPerformed 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 | Other | ST |
| Velocity-enhanced trainingPerformed 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. | Other | VT |
Primary outcome
Muscle thickness
Time frame: before and after intervention
3 secondary outcomes
Fascicle length
Time frame: before and after intervention
Muscle strength (peak torque)
Time frame: before and after intervention
Muscle power
Time frame: before and after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
- Background: PubMed 17475377Mohagheghi 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.
- Background: PubMed 12005316Shortland 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.
- Background: PubMed 7672470Damiano 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.
- Background: PubMed 19264384Moreau 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.
- Background: PubMed 19459913Moreau 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.
- Moreau Faculty web pageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noelle G Moreau, PhD, PT principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional strength training and Velocity-enhanced training in people with Cerebral Palsy, run by Medical University of South Carolina at 1 site 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 3 inclusion and 2 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 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Muscle thickness (time frame: before and after intervention). 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 NCT00629070, which also lists 5 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 17 May 2018.