Unilateral Cerebral PalsyMouvsupTCIHemiNCT03099993
Sensitivity of an Upper Limb Motion Analysis Protocol to Changes in Kinematics and Muscle Activity After Constraint Induced Therapy in Children With Hemiplegia
A study testing Measurement of maximal forces of elbow pronosupination and flexion-extension in people with Unilateral Cerebral Palsy, run by Nantes University Hospital at 1 site in France.
Trial summary
In France, Cerebral Palsy (CP) affects 1 in 450 births. It results from lesions of the brain, before, during, or shortly after birth. These non-progressive lesions cause muscle impairments, responsible for activity limitations. These muscle impairments include muscle stiffness, and muscle weakness. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Unilateral Cerebral Palsy
- What is being tested?
- Measurement of maximal forces of elbow pronosupination and flexion-extension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 28 Mar 2017to 17 Apr 2019
- 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 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants (excluding healthy volunteers) must have hemiparesis.
- Children must be between 6 and 17 years of age. The protocol requires a minimum concentration difficult to obtain for children under 6 years.
- Participants must be enrolled in a health insurance plan.
Who cannot join
- Inability to understand or follow instructions during 1h30.
- Physical incapacity to carry out the requested movements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantified Analysis of the Movements of the Upper Limb of Children With Hemiparesis Participating in the Stress Induced Therapy Program
In France, Cerebral Palsy (CP) affects 1 in 450 births. It results from lesions of the brain, before, during, or shortly after birth. These non-progressive lesions cause muscle impairments, responsible for activity limitations. These muscle impairments include muscle stiffness, and muscle weakness. Children with Unilateral CP (UCP) have these impairments on only one side of the body. To compensate for activity limitations with their impaired arm, these children over-use their non-impaired arm. The objective of constraint-induced therapy (CIT) is to minimize this asymmetry which deteriorates mobility on the impaired side, by forcing the child to only use its impaired arm several hours a day during several weeks of therapy. It is known using clinical tests that this therapy improves the overall motor function of the impaired arm. However, the underlying mechanisms are yet unknown. An understanding of these mechanisms would suggest ways to maximize the effectiveness of this therapy, which requires a significant commitment from the child and its family. The investigaors propose in this project a quantitative and objective evaluation of the effect of CIT on the movements of the impaired arm of children with UCP. The investogators focus their analysis on muscle activation, to assess which aspect of muscle impairments is modified by CIT. To this end, the investigators will use sensors identical to those already used in clinics for the Quantified Gait Analysis of children with CP, recognized since 2006 by the Haute Autorité de Santé as providing key supplementary data in the evaluation of complex gait disorders. Results from this study will provide leads to optimize CIT. Some children could for example benefit from CIT paired with treatments to reduce muscle stiffness or to strengthen muscles
Read the detailed description
Quantitative and objective evaluation of upper limb movements will take place in a motion analysis laboratory and will take place as follow:
- A clinical exam of the participant will be performed by the physician to collect maximal passive joint amplitudes with a goniometer and anatomical measures (length, circumference) of the upper limb.
- The participant will be equipped with surface electromyographic electrodes to measure the activation of his superficial muscles, and with retroreflective markers placed on anatomical landmarks of his thorax, shoulder, and arm, to measure upper limb kinematics with a 3D motion capture system composed of 8 VICON cameras.
- Maximal forces of elbow pronosupination and flexion-extension will be measured with a portable dynamometer.
- The participant will be placed on a height adjustable bench, in the center of the laboratory. He will be asked to perform upper limb movements:
- A few movements not measured, to familiarize with the equipment;
- Recorded movements: a trial is composed of a few consecutive cycles of a movement such as elbow flexion-extension. A trial usually last about 10seconds. A few seconds-time of rest is imposed between each trial. The required movements are the following: elbow flexion-extension, elbow pronosupination, and "hand to mouth".
- Finally, the participant will be asked to lie down on an exam table and to rest relax, in order to measure the electromyographic signal of his muscles at rest.
Duration of the protocol is about 1h30, with less than 30seconds of effort, and a few minutes of performing simple upper limb movements.
- Conditions
- Unilateral Cerebral Palsy
- Being tested
- Measurement of maximal forces of elbow pronosupination and flexion-extension
- Keywords
- Unilateral cerebral palsy, kinematics, electromyography, constraint-induced therapy, muscle activation, upper limb, child
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of maximal forces of elbow pronosupination and flexion-extensionOther
Maximal forces of elbow pronosupination and flexion-extension will be measured with a portable dynamometer.
| Study group | Role | What they receive |
|---|---|---|
| A: Healthy volunteers | Other | Not described Receives: Other: Measurement of maximal forces of elbow pronosupination and flexion-extension |
| B: Patient with heamiplegia | Other | Not described Receives: Other: Measurement of maximal forces of elbow pronosupination and flexion-extension |
| C: Patient with heamiplegia and constraint induced therapy | Other | arm with constraint induced therapy (done before the protocol) Receives: Other: Measurement of maximal forces of elbow pronosupination and flexion-extension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper limb muscle activation envelopes
Muscle activation envelopes come from electromyographic signals of upper limb muscles.
Measured: 5 weeks
kinematics during active movements
Kinematics: angles, velocities, accelerations of the thorax, shoulder, elbow and wrist in the three anatomical plans (sagittal, frontal, transverse).
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start28 Mar 2017
- Primary completion17 Apr 2019
- Study completion17 Apr 2019
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 Unilateral Cerebral PalsyStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099993
- Sponsor's protocol ID
- RC15_0310
- Acronym
- MouvsupTCIHemi
- Status last verified
- Jun 2019
- First submitted
- 20 Mar 2017
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sarcher A, Brochard S, Hug F, Letellier G, Raison M, Perrouin-Verbe B, Sangeux M, Gross R. Patterns of upper limb muscle activation in children with unilateral spastic cerebral palsy: Variability and detection of deviations. Clin Biomech (Bristol). 2018 Nov;59:85-93. doi: 10.1016/j.clinbiomech.2018.09.005. Epub 2018 Sep 5.
PubMed 30216783
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantified Analysis of the Movements of the Upper Limb of Children With Hemiparesis Participating in the Stress Induced Therapy Program
- ClinicalTrials.gov ID
- NCT03099993
- Acronym / sponsor ID
- MouvsupTCIHemi / RC15_0310
- Conditions
- Unilateral Cerebral Palsy
- Keywords
- Unilateral cerebral palsy, kinematics, electromyography, constraint-induced therapy, muscle activation, upper limb, child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 17 Apr 2019 (actual)
- Study completion
- 17 Apr 2019 (actual)
- First posted
- 4 Apr 2017 (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.
In France, Cerebral Palsy (CP) affects 1 in 450 births. It results from lesions of the brain, before, during, or shortly after birth. These non-progressive lesions cause muscle impairments, responsible for activity limitations. These muscle impairments include muscle stiffness, and muscle weakness. Children with Unilateral CP (UCP) have these impairments on only one side of the body. To compensate for activity limitations with their impaired arm, these children over-use their non-impaired arm. The objective of constraint-induced therapy (CIT) is to minimize this asymmetry which deteriorates mobility on the impaired side, by forcing the child to only use its impaired arm several hours a day during several weeks of therapy. It is known using clinical tests that this therapy improves the overall motor function of the impaired arm. However, the underlying mechanisms are yet unknown. An understanding of these mechanisms would suggest ways to maximize the effectiveness of this therapy, which requires a significant commitment from the child and its family. The investigaors propose in this project a quantitative and objective evaluation of the effect of CIT on the movements of the impaired arm of children with UCP. The investogators focus their analysis on muscle activation, to assess which aspect of muscle impairments is modified by CIT. To this end, the investigators will use sensors identical to those already used in clinics for the Quantified Gait Analysis of children with CP, recognized since 2006 by the Haute Autorité de Santé as providing key supplementary data in the evaluation of complex gait disorders. Results from this study will provide leads to optimize CIT. Some children could for example benefit from CIT paired with treatments to reduce muscle stiffness or to strengthen muscles
Detailed description
Quantitative and objective evaluation of upper limb movements will take place in a motion analysis laboratory and will take place as follow:
- A clinical exam of the participant will be performed by the physician to collect maximal passive joint amplitudes with a goniometer and anatomical measures (length, circumference) of the upper limb.
- The participant will be equipped with surface electromyographic electrodes to measure the activation of his superficial muscles, and with retroreflective markers placed on anatomical landmarks of his thorax, shoulder, and arm, to measure upper limb kinematics with a 3D motion capture system composed of 8 VICON cameras.
- Maximal forces of elbow pronosupination and flexion-extension will be measured with a portable dynamometer.
- The participant will be placed on a height adjustable bench, in the center of the laboratory. He will be asked to perform upper limb movements:
- A few movements not measured, to familiarize with the equipment;
- Recorded movements: a trial is composed of a few consecutive cycles of a movement such as elbow flexion-extension. A trial usually last about 10seconds. A few seconds-time of rest is imposed between each trial. The required movements are the following: elbow flexion-extension, elbow pronosupination, and "hand to mouth".
- Finally, the participant will be asked to lie down on an exam table and to rest relax, in order to measure the electromyographic signal of his muscles at rest.
Duration of the protocol is about 1h30, with less than 30seconds of effort, and a few minutes of performing simple upper limb movements.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A: Healthy volunteers | Other | Other: Measurement of maximal forces of elbow pronosupination and flexion-extension |
| B: Patient with heamiplegia | Other | Other: Measurement of maximal forces of elbow pronosupination and flexion-extension |
| C: Patient with heamiplegia and constraint induced therapy | Other | Other: Measurement of maximal forces of elbow pronosupination and flexion-extensionarm with constraint induced therapy (done before the protocol) |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Participants (excluding healthy volunteers) must have hemiparesis.
- Children must be between 6 and 17 years of age. The protocol requires a minimum concentration difficult to obtain for children under 6 years.
- Participants must be enrolled in a health insurance plan.
Key exclusion criteria (2 listed)
- Inability to understand or follow instructions during 1h30.
- Physical incapacity to carry out the requested movements
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 of maximal forces of elbow pronosupination and flexion-extensionMaximal forces of elbow pronosupination and flexion-extension will be measured with a portable dynamometer. | Other | A: Healthy volunteers, B: Patient with heamiplegia, C: Patient with heamiplegia and constraint induced therapy |
Primary outcome
Upper limb muscle activation envelopes
Time frame: 5 weeks
Muscle activation envelopes come from electromyographic signals of upper limb muscles.
kinematics during active movements
Time frame: 5 weeks
Kinematics: angles, velocities, accelerations of the thorax, shoulder, elbow and wrist in the three anatomical plans (sagittal, frontal, transverse).
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 14 Sep 2026.
- Results publication: PubMed 30216783Sarcher A, Brochard S, Hug F, Letellier G, Raison M, Perrouin-Verbe B, Sangeux M, Gross R. Patterns of upper limb muscle activation in children with unilateral spastic cerebral palsy: Variability and detection of deviations. Clin Biomech (Bristol). 2018 Nov;59:85-93. doi: 10.1016/j.clinbiomech.2018.09.005. Epub 2018 Sep 5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 of maximal forces of elbow pronosupination and flexion-extension in people with Unilateral Cerebral Palsy, run by Nantes University Hospital 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 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 14 Sep 2026. 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?
Upper limb muscle activation envelopes (time frame: 5 weeks). The study lists 2 primary outcomes in all. 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 NCT03099993, 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 14 Sep 2026.