Cerebral PalsyNCT03714269
Acute Effects of a Passive Stretching Session on the Mechanical Properties of Medial Gastrocnemius Muscle in Children With Cerebral Palsy
A study testing measurement evaluated with an isokinetic dynamometer, measurement evaluated with an 2D ultrasound and assessment of the level of discomfort in people with Cerebral Palsy, 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… Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- measurement evaluated with an isokinetic dynamometer, measurement evaluated with an 2D ultrasound and assessment of the level of discomfort
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 19 Oct 2018to 28 Nov 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 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with cerebral palsy of the spastic type
- Children with a maximum dorsal ankle flexion amplitude limitation of less than 10°.
Who cannot join
- Children who have undergone surgery on the lower limbs.
- Children with a botulinum toxin injection and/or a series of elongation casts for less than three months.
- Children with ongoing analgesic treatment
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. This study assess efficacy of an acute high intensity and long-time stretching session of plantarflexors muscle on their viscoelasticity properties and maximal dorsiflexion angle gain. Single stretching session is characterized by high intensity and long time (5 minutes).
- Conditions
- Cerebral Palsy
- Being tested
- measurement evaluated with an isokinetic dynamometer, measurement evaluated with an 2D ultrasound, assessment of the level of discomfort
- Keywords
- children, medial gastrocnemius 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.
measurement evaluated with an isokinetic dynamometerOther
measurement of the maximum dorsiflexion angle in degrees evaluated on an isokinetic dynamometer
measurement evaluated with an 2D ultrasoundOther
- simultaneous recording of force torque, joint angle and myotendinous junction displacement in 2D ultrasound during 5 passive mobilization cycles of ankle flexion-extension at very low speed
- recording of static images in 2D ultrasound representing the proximal insertion of the gastrocnemius muscle in the internal condyle of the femur, the myotendinous junction.
assessment of the level of discomfortOther
visual analogue scale (0 = no discomfort and 10 = maximal discomfort)
| Study group | Role | What they receive |
|---|---|---|
| Children with cerebral palsy of the spastic type | Experimental | Not described Receives: Other: measurement evaluated with an isokinetic dynamometer; Other: measurement evaluated with an 2D ultrasound; Other: assessment of the level of discomfort |
What is being measured
The primary outcome is the main question the study is designed to answer.
slope of the torque curve force-ankle joint angle in the joint area -25° plantar flexion/maximum dorsal flexion
Measured: baseline
Secondary outcomes (4)
Maximum dorsal flexion angle of ankle, knee in maximum extension position
Measured: at 5 minutes
slope of the force-displacement torque curve myotendinous junction of the Sural Triceps in the articular sector -25° plantar flexion/maximum dorsal flexion
Measured: at 5 minutes
lengths of the musculotendinous unit of the Triceps Sural muscle, the muscular body of the gastrocnemius muscle and the Achilles tendon in cm measured at rest, knee in maximum extension position, ankle angle in neutral plantar/dorsal flexion position.
Measured: at 5 minutes
visual analogue scale of discomfort
0 = not discomfort and 10 = maximal discomfort
Measured: at 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start19 Oct 2018
- Primary completion28 Nov 2018
- Study completion28 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent GAUTHERON, Principal investigator, CHU de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714269
- Sponsor's protocol ID
- 18CH121
- Other IDs
- ANSM
- Status last verified
- Oct 2018
- First submitted
- 18 Oct 2018
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boulard C, Gautheron V, Lapole T. Acute passive stretching has no effect on gastrocnemius medialis stiffness in children with unilateral cerebral palsy. Eur J Appl Physiol. 2023 Mar;123(3):467-477. doi: 10.1007/s00421-022-05046-7. Epub 2022 Nov 1.
PubMed 36318307
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of a Passive Stretching Session on the Mechanical Properties of Medial Gastrocnemius Muscle in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03714269
- Acronym / sponsor ID
- 18CH121
- Conditions
- Cerebral Palsy
- Keywords
- children, medial gastrocnemius muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 19 Oct 2018 (actual)
- Primary completion
- 28 Nov 2018 (actual)
- Study completion
- 28 Nov 2018 (actual)
- First posted
- 22 Oct 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. This study assess efficacy of an acute high intensity and long-time stretching session of plantarflexors muscle on their viscoelasticity properties and maximal dorsiflexion angle gain. Single stretching session is characterized by high intensity and long time (5 minutes).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with cerebral palsy of the spastic type | Experimental | Other: measurement evaluated with an isokinetic dynamometer, Other: measurement evaluated with an 2D ultrasound, Other: assessment of the level of discomfort |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with cerebral palsy of the spastic type
- Children with a maximum dorsal ankle flexion amplitude limitation of less than 10°.
Key exclusion criteria (3 listed)
- Children who have undergone surgery on the lower limbs.
- Children with a botulinum toxin injection and/or a series of elongation casts for less than three months.
- Children with ongoing analgesic treatment
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 |
|---|---|---|
| measurement evaluated with an isokinetic dynamometermeasurement of the maximum dorsiflexion angle in degrees evaluated on an isokinetic dynamometer | Other | Children with cerebral palsy of the spastic type |
| measurement evaluated with an 2D ultrasound* simultaneous recording of force torque, joint angle and myotendinous junction displacement in 2D ultrasound during 5 passive mobilization cycles of ankle flexion-extension at very low speed * recording of static images in 2D ultrasound representing the proximal insertion of the gastrocnemius muscle in the internal condyle of the femur, the myotendinous junction. | Other | Children with cerebral palsy of the spastic type |
| assessment of the level of discomfortvisual analogue scale (0 = no discomfort and 10 = maximal discomfort) | Other | Children with cerebral palsy of the spastic type |
Primary outcome
slope of the torque curve force-ankle joint angle in the joint area -25° plantar flexion/maximum dorsal flexion
Time frame: baseline
4 secondary outcomes
Maximum dorsal flexion angle of ankle, knee in maximum extension position
Time frame: at 5 minutes
slope of the force-displacement torque curve myotendinous junction of the Sural Triceps in the articular sector -25° plantar flexion/maximum dorsal flexion
Time frame: at 5 minutes
lengths of the musculotendinous unit of the Triceps Sural muscle, the muscular body of the gastrocnemius muscle and the Achilles tendon in cm measured at rest, knee in maximum extension position, ankle angle in neutral plantar/dorsal flexion position.
Time frame: at 5 minutes
visual analogue scale of discomfort
Time frame: at 5 minutes
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 30 May 2019.
- Derived from this study: PubMed 36318307Boulard C, Gautheron V, Lapole T. Acute passive stretching has no effect on gastrocnemius medialis stiffness in children with unilateral cerebral palsy. Eur J Appl Physiol. 2023 Mar;123(3):467-477. doi: 10.1007/s00421-022-05046-7. Epub 2022 Nov 1.
- 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 principal investigator
CHU 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 measurement evaluated with an isokinetic dynamometer, measurement evaluated with an 2D ultrasound and assessment of the level of discomfort in people with Cerebral Palsy, 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 2 inclusion and 3 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 30 May 2019. 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 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?
slope of the torque curve force-ankle joint angle in the joint area -25° plantar flexion/maximum dorsal flexion (time frame: baseline). 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 NCT03714269, which also lists 1 linked publication.
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 30 May 2019.