Cerebral Palsy, SpasticLONGSTRETCH PCNCT03565172
Efficacy of a Long Term, High Intensity and Long Time Stretch Training Program on Viscoelasticity Plantarflexors Muscle in Children With Cerebral Palsy (CP).
A study testing isokinetic dynamometer with ultrasound, Visual Analog Scale (VAS) and Stretching in people with Cerebral Palsy, Spastic and Children, Only, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Children with cerebral palsy present early in the childhood altered muscular properties, as soon as structural or stiffness. In the gastrocnemius muscle, altered muscular properties are characterized by short muscle belly length and increased stiffness which contribute to contracture and limiting joint range of motion. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Cerebral Palsy, Spastic, Children, Only
- What is being tested?
- isokinetic dynamometer with ultrasound, Visual Analog Scale (VAS) and Stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jul 2018to 26 Jul 2018
- 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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 8 to 16 years
- Children diagnosed spastic cerebral palsy
- Children with decrease maximal dorsiflexion angle under +5° in the last four weeks
- Children who don't understand instructions
Who cannot join
- Children who had damage orthopedics or surgical operation contraindicating realization of the experimental protocol
- Hospitalization incompatible with the progress of the protocol.
- Children who had botulinum injection, extensions casts or the implementation of new equipment (night or day orthosis) for less than three months or the progress of the protocol.
- Children having analgesic treatment in progress
Trial locations and contacts
1 site in 1 country.
About this study
Children with cerebral palsy present early in the childhood altered muscular properties, as soon as structural or stiffness. In the gastrocnemius muscle, altered muscular properties are characterized by short muscle belly length and increased stiffness which contribute to contracture and limiting joint range of motion.
Read the detailed description
This study assess efficacy of a long term stretching program of plantarflexors muscle on their viscoelasticity properties and maximal dorsiflexion angle gain. Stretching program is characterized by 3 phases: baseline, intervention and follow-up.
- Conditions
- Cerebral Palsy, Spastic, Children, Only
- Being tested
- isokinetic dynamometer with ultrasound, Visual Analog Scale (VAS), Stretching
- Keywords
- cerebral palsy, stretching, isokinetic dynamometer, ultrasound, ankle, children
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isokinetic dynamometer with ultrasoundDiagnostic test
children are lying prone on a isokinetic dynamometer with ultrasound which stretches spastic and paretic plantarflexors muscles very slowly until maximal torque tolerated. The parameters can be measured.
Visual Analog Scale (VAS)Other
the discomfort level will be measured by Visual Analog Scale (VAS) completed by children. 0 = no discomfort and 10 = maximum discomfort
StretchingDiagnostic test
the ankle of children will be mobilized for 5 minutes (first two weeks) to 10 minutes (last two weeks).
| Study group | Role | What they receive |
|---|---|---|
| Children with spastic cerebral palsy | Experimental | Children with spastic cerebral palsy will be included. They will have 3 phases:
* Baseline: 4, 5 or 6 evaluations
* Intervention: 9 evaluations before and after every stretching session
* Follow-up: 4, 5 or 6 evaluations
The evaluation part will be composed of isokinetic dynamometer with ultrasound and Visual Analog Scale (VAS). The number of evaluations at baseline and follow-up will be randomized before the study by Single Case Experimental Design (SCED) methodology. Receives: Diagnostic Test: isokinetic dynamometer with ultrasound; Other: Visual Analog Scale (VAS); Diagnostic Test: Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
slope of the torque-angle curve
Analysis of the slope of the torque-angle curve in Nm/°. It is measured by isokinetic dynamometer with ultrasound.
Measured: up to 12 weeks
Secondary outcomes (5)
Maximal dorsiflexion angle
Analysis of the maximal dorsiflexion angle in degrees. It is measured by isokinetic dynamometer with ultrasound.
Measured: up to 12 weeks
Slope of the torque- MyoTendinous Junction (MTJ) displacement
Analysis of the Slope of the torque- MyoTendinous Junction (MTJ) displacement in cm/°.
It is measured by isokinetic dynamometer with ultrasound.
Measured: up to 12 weeks
MyoTendinous Junction (MTJ) displacement of muscle triceps sural
Analysis of the MyoTendinous Junction (MTJ) displacement of muscle triceps sural in cm.
It is measured by isokinetic dynamometer with ultrasound.
Measured: up to 12 weeks
muscle triceps sural, muscle body of the medial gastrocnemius muscle and Achilles tendon
Correlation of the length of Musculo-Tendinous Unit (MTU) of muscle triceps sural, muscle body of the medial gastrocnemius muscle and Achilles tendon.
It is measured by isokinetic dynamometer with ultrasound.
Measured: up to 12 weeks
discomfort level
Analysis of the discomfort level. It is measured by Visual Analog Scale (VAS) completed by children. 0 = no discomfort and 10 = maximum discomfort
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start2 Jul 2018
- Primary completion26 Jul 2018
- Study completion26 Jul 2018
Why it stopped: protocol with too many constraints. long protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy, SpasticStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The methodology used is : Single Case Experimental Design (SCED).
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent GAUTHERON, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565172
- Sponsor's protocol ID
- 18CH033
- Other IDs
- ID-RCB
- Acronym
- LONGSTRETCH PC
- Status last verified
- Aug 2022
- First submitted
- 12 Jun 2018
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Long Term, High Intensity and Long Time Stretch Training Program on Viscoelasticity Plantarflexors Muscle in Children With Cerebral Palsy (CP).
- ClinicalTrials.gov ID
- NCT03565172
- Acronym / sponsor ID
- LONGSTRETCH PC / 18CH033
- Conditions
- Cerebral Palsy, Spastic, Children, Only
- Keywords
- cerebral palsy, stretching, isokinetic dynamometer, ultrasound, ankle, children
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: protocol with too many constraints. long protocol
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 26 Jul 2018 (actual)
- Study completion
- 26 Jul 2018 (actual)
- First posted
- 21 Jun 2018 (actual)
- 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.
Children with cerebral palsy present early in the childhood altered muscular properties, as soon as structural or stiffness. In the gastrocnemius muscle, altered muscular properties are characterized by short muscle belly length and increased stiffness which contribute to contracture and limiting joint range of motion.
Detailed description
This study assess efficacy of a long term stretching program of plantarflexors muscle on their viscoelasticity properties and maximal dorsiflexion angle gain. Stretching program is characterized by 3 phases: baseline, intervention and follow-up.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The methodology used is : Single Case Experimental Design (SCED).
| Arm | Type | Receives |
|---|---|---|
| Children with spastic cerebral palsy | Experimental | Diagnostic Test: isokinetic dynamometer with ultrasound, Other: Visual Analog Scale (VAS), Diagnostic Test: StretchingChildren with spastic cerebral palsy will be included. They will have 3 phases: * Baseline: 4, 5 or 6 evaluations * Intervention: 9 evaluations before and after every stretching session * Follow-up: 4, 5 or 6 evaluations The evaluation part will be composed of isokinetic dynamometer with ultrasound and Visual Analog Scale (VAS). The number of evaluations at baseline and follow-up will be randomized before the study by Single Case Experimental Design (SCED) methodology. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 8 to 16 years
- Children diagnosed spastic cerebral palsy
- Children with decrease maximal dorsiflexion angle under +5° in the last four weeks
- Children who don't understand instructions
Key exclusion criteria (4 listed)
- Children who had damage orthopedics or surgical operation contraindicating realization of the experimental protocol
- Hospitalization incompatible with the progress of the protocol.
- Children who had botulinum injection, extensions casts or the implementation of new equipment (night or day orthosis) for less than three months or the progress of the protocol.
- Children having analgesic treatment in progress
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 |
|---|---|---|
| isokinetic dynamometer with ultrasoundchildren are lying prone on a isokinetic dynamometer with ultrasound which stretches spastic and paretic plantarflexors muscles very slowly until maximal torque tolerated. The parameters can be measured. | Diagnostic test | Children with spastic cerebral palsy |
| Visual Analog Scale (VAS)the discomfort level will be measured by Visual Analog Scale (VAS) completed by children. 0 = no discomfort and 10 = maximum discomfort | Other | Children with spastic cerebral palsy |
| Stretchingthe ankle of children will be mobilized for 5 minutes (first two weeks) to 10 minutes (last two weeks). | Diagnostic test | Children with spastic cerebral palsy |
Primary outcome
slope of the torque-angle curve
Time frame: up to 12 weeks
Analysis of the slope of the torque-angle curve in Nm/°. It is measured by isokinetic dynamometer with ultrasound.
5 secondary outcomes
Maximal dorsiflexion angle
Time frame: up to 12 weeks
Slope of the torque- MyoTendinous Junction (MTJ) displacement
Time frame: up to 12 weeks
MyoTendinous Junction (MTJ) displacement of muscle triceps sural
Time frame: up to 12 weeks
muscle triceps sural, muscle body of the medial gastrocnemius muscle and Achilles tendon
Time frame: up to 12 weeks
discomfort level
Time frame: up to 12 weeks
Results and safety
The study was stopped early (reason given: protocol with too many constraints. long protocol). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Vincent GAUTHERON, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing isokinetic dynamometer with ultrasound, Visual Analog Scale (VAS) and Stretching in people with Cerebral Palsy, Spastic and Children, Only, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 4 Aug 2022. 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 France. 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 was stopped early (reason given: protocol with too many constraints. long protocol). Results are not available in the source record.
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?
slope of the torque-angle curve (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2022.