HemiplegiaNCT02549807
Measurement by 2D Ultrasound of the Pennation Angle and Elasticity of Gastrocnemius Muscle
An observational study of Hemiplegia, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Hemiplegic adults after stroke (stroke), children and adolescents with cerebral palsy (CP) have both muscles spastic and paresis. These movement disorders are likely to cause muscle changes both structural and viscoelastic involved in the alteration of neuromotor functions such as walking. Read more about this study
- Who is it for?
- Ages 5 to 75 years
- Conditions the study is for
- Hemiplegia
- What is being tested?
- Muscle elasticity measure
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2014to Sep 2014
- Phase
- Observational
- 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 5 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hemiplegic adults/children/adolescent after stroke ,
Who may be able to join
- Children
- Cerebral Paralyzed, with an infantile cerebral hemiplegia, spastic type with a level of functional independence of walking I or II of the GMFCS level.
- Having a level of spasticity in gastrocnemius muscles of the lower member plegic higher or equal to X1, V 2, on the scale of Tardieu.
- Boys aged 5 to 12 years and girls aged 5 to 11 years.
- Adolescent
- Cerebral Paralyzed, with an infantile cerebral hemiplegia, spastic type with a level of functional independence of walking I or II of the GMFCS level.
Show all 12Show fewer
- Having a level of spasticity in gastrocnemius muscles of the lower member plegic higher or equal to X1, V 2, on the scale of Tardieu.
- Boys aged 11-18 years and girls aged 10-18 years.
- Adult
- Aged 18 to 75, of both sexes. - Having suffered a stroke (stroke) regardless of the date of the stroke. - Presenting hemiplegia cerebral vascular following the stroke.
- walking, with or without technical assistance or device (splint, cane ...)
- Presenting a focused plegic spasticity in the lower limb, the plantar flexors, assessed by Tardieu scale and higher than or equal to X1, V2.
Who cannot join
- Children and adolescent
- Having received botulinum toxin injections in the gastrocnemius muscle in the three months preceding the assessment.
- Having received lengthening plasters in the three months preceding the assessment.
- Having benefited from therapeutic to target muscle (baclofen, a muscle relaxant ...) the beginning of the treatment would have started in the months preceding the assessment.
- Having enjoyed orthopedic surgery at the muscular structures, tendons and bone of the leg plegic.
- Adult
Show all 10Show fewer
- Presenting a concomitant muscle disease (eg myopathy, myositis ...).
- Having received injections of botulinum toxin in the gastrocnemius muscle in the three months preceding the assessment.
- Having benefited from therapeutic to target muscle (baclofen, a muscle relaxant ...) the beginning of the treatment would have started in the months preceding the assessment.
- Having enjoyed orthopedic or neurological surgery at the plegic lower limb.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Reproducibility of the Measurement by 2D Ultrasound and Sonoelastometry of the Pennation Angle and Elasticity of the Medial Gastrocnemius Muscle in Children/Adolescent/Adult Cerebral Hemiplegia After Stroke
Hemiplegic adults after stroke (stroke), children and adolescents with cerebral palsy (CP) have both muscles spastic and paresis. These movement disorders are likely to cause muscle changes both structural and viscoelastic involved in the alteration of neuromotor functions such as walking. Therefore, it seems interesting to study the structure of these muscles with available imaging techniques. The medial gastrocnemius muscle presents architectural characteristics which allows easy evaluation 2D ultrasound. The literature lacks data on the reproducibility of the measurement, by 2D ultrasound, of the pennation angle and muscular thickness, particularly in children. In addition, the sonoelastometry by Supersonic ShearWave Imaging (SSI) is a new technique of ultrasound, non-invasive, dynamic, which allows the calculation of the modulus of elasticity within a muscle tissue. This allows to consider new perspectives evaluation of the viscoelastic properties of the muscle. No studies have evaluated the reproducibility of this method in adults/children/ adolescent after stroke and hemiplegia.
Read the detailed description
A 1 week apart, an ultrasound examination will be conducted on the hemiplegic leg side, while lying on his stomach and on the back. The thickness, elasticity and the pennation angle of the medial gastrocnemius muscle will be measured.
- Conditions
- Hemiplegia
- Being tested
- Muscle elasticity measure
- Keywords
- Vascular hemiplegia, 2D ultrasound, Muscle elasticity, Pennation angle
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle elasticity measureDevice
an ultrasound examination will be conducted on the hemiplegic leg side, while lying on his stomach and on the back. The thickness, elasticity and the angle of the medial gastrocnemius muscle pennation will be measured.
| Study group | Role | What they receive |
|---|---|---|
| Children muscle elasticity measure | an ultrasound examination will be conducted on the hemiplegic leg side, while lying on his stomach and on the back. The thickness, elasticity and the angle of the medial gastrocnemius muscle pennation will be measured (muscle elasticity measure) Receives: Device: Muscle elasticity measure | |
| Adolescent muscle elasticity measure | an ultrasound examination will be conducted on the hemiplegic leg side, while lying on his stomach and on the back. The thickness, elasticity and the angle of the medial gastrocnemius muscle pennation will be measured ((muscle elasticity measure) Receives: Device: Muscle elasticity measure | |
| Adult muscle elasticity measure | an ultrasound examination will be conducted on the hemiplegic leg side, while lying on his stomach and on the back. The thickness, elasticity and the angle of the medial gastrocnemius muscle pennation will be measured (muscle elasticity measure) Receives: Device: Muscle elasticity measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pennation angle
Pennation angle of the medial gastrocnemius muscle measuring in degrees in a sagittal section by 2D ultrasound.
Measured: Day 1
Secondary outcomes (1)
Muscle Elasticity
Measurement of elastic modulus (kPa) of anterior gastrocnemius muscles, on a sagittal section by sonoelastometry ShearWave ™.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startJul 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent GAUTHERON, MD PhD, Principal investigator, CHU de SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549807
- Sponsor's protocol ID
- 1408031
- Other IDs
- 2014-A00452-45
- Status last verified
- Sep 2015
- First submitted
- 11 Sep 2015
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Reproducibility of the Measurement by 2D Ultrasound and Sonoelastometry of the Pennation Angle and Elasticity of the Medial Gastrocnemius Muscle in Children/Adolescent/Adult Cerebral Hemiplegia After Stroke
- ClinicalTrials.gov ID
- NCT02549807
- Acronym / sponsor ID
- 1408031
- Conditions
- Hemiplegia
- Keywords
- Vascular hemiplegia, 2D ultrasound, Muscle elasticity, Pennation angle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 15 Sep 2015 (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.
Hemiplegic adults after stroke (stroke), children and adolescents with cerebral palsy (CP) have both muscles spastic and paresis. These movement disorders are likely to cause muscle changes both structural and viscoelastic involved in the alteration of neuromotor functions such as walking. Therefore, it seems interesting to study the structure of these muscles with available imaging techniques. The medial gastrocnemius muscle presents architectural characteristics which allows easy evaluation 2D ultrasound. The literature lacks data on the reproducibility of the measurement, by 2D ultrasound, of the pennation angle and muscular thickness, particularly in children. In addition, the sonoelastometry by Supersonic ShearWave Imaging (SSI) is a new technique of ultrasound, non-invasive, dynamic, which allows the calculation of the modulus of elasticity within a muscle tissue. This allows to consider new perspectives evaluation of the viscoelastic properties of the muscle. No studies have evaluated the reproducibility of this method in adults/children/ adolescent after stroke and hemiplegia.
Detailed description
A 1 week apart, an ultrasound examination will be conducted on the hemiplegic leg side, while lying on his stomach and on the back. The thickness, elasticity and the pennation angle of the medial gastrocnemius muscle will be measured.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children muscle elasticity measure | – | Device: Muscle elasticity measurean ultrasound examination will be conducted on the hemiplegic leg side, while lying on his stomach and on the back. The thickness, elasticity and the angle of the medial gastrocnemius muscle pennation will be measured (muscle elasticity measure) |
| Adolescent muscle elasticity measure | – | Device: Muscle elasticity measurean ultrasound examination will be conducted on the hemiplegic leg side, while lying on his stomach and on the back. The thickness, elasticity and the angle of the medial gastrocnemius muscle pennation will be measured ((muscle elasticity measure) |
| Adult muscle elasticity measure | – | Device: Muscle elasticity measurean ultrasound examination will be conducted on the hemiplegic leg side, while lying on his stomach and on the back. The thickness, elasticity and the angle of the medial gastrocnemius muscle pennation will be measured (muscle elasticity measure) |
Who may qualify
- Ages
- 5 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hemiplegic adults/children/adolescent after stroke ,
Key inclusion criteria (12 listed)
- Children
- Cerebral Paralyzed, with an infantile cerebral hemiplegia, spastic type with a level of functional independence of walking I or II of the GMFCS level.
- Having a level of spasticity in gastrocnemius muscles of the lower member plegic higher or equal to X1, V 2, on the scale of Tardieu.
- Boys aged 5 to 12 years and girls aged 5 to 11 years.
- Adolescent
Key exclusion criteria (10 listed)
- Children and adolescent
- Having received botulinum toxin injections in the gastrocnemius muscle in the three months preceding the assessment.
- Having received lengthening plasters in the three months preceding the assessment.
- Having benefited from therapeutic to target muscle (baclofen, a muscle relaxant ...) the beginning of the treatment would have started in the months preceding the assessment.
- Having enjoyed orthopedic surgery at the muscular structures, tendons and bone of the leg plegic.
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 |
|---|---|---|
| Muscle elasticity measurean ultrasound examination will be conducted on the hemiplegic leg side, while lying on his stomach and on the back. The thickness, elasticity and the angle of the medial gastrocnemius muscle pennation will be measured. | Device | Adolescent muscle elasticity measure, Adult muscle elasticity measure, Children muscle elasticity measure |
Primary outcome
Pennation angle
Time frame: Day 1
Pennation angle of the medial gastrocnemius muscle measuring in degrees in a sagittal section by 2D ultrasound.
1 secondary outcome
Muscle Elasticity
Time frame: Day 1
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 15 Sep 2015.
Related trials for Hemiplegia
Not yet recruiting
Effects of Upper Extremity Physiotherapy and Home Exercises on Functional Outcomes in Individuals With Stroke
Stroke
Recruiting
Task-Oriented Training Versus High-Intensity Gait Training in People With Chronic Stroke
Stroke, Hemiplegia
Active, not recruitingObservational study
Studies of the Variable Phenotypic Presentations of Rapid-Onset Dystonia Parkinsonism and Other Movement Disorders
Dystonia, Parkinsonism
RecruitingObservational study
Post-Stroke Apraxia, Motor Function, Balance, and Gait
Stroke, Ideomotor Apraxia
RecruitingObservational study
Ideomotor Apraxia and Robotic Gait Rehabilitation Outcomes After Stroke
Stroke, Ideomotor Apraxia
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, MD PhD 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?
An observational study of Hemiplegia, 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 12 inclusion and 10 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 15 Sep 2015. 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?
Pennation angle (time frame: Day 1). 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 15 Sep 2015.