Hemiplegic Cerebral PalsyPC MIROIRNCT02131909
PC MIROIR : Effects of Mirror Therapy in Children With Hemiplegic Cerebral Palsy
A study testing mirror therapy and bimanual rehabilitation exercises in people with Hemiplegic Cerebral Palsy, run by Rennes University Hospital at 1 site in France.
Trial summary
This is a randomized and comparative prospective test, monocentric and controlled (mirror therapy versus bimanual rehabilitation exercises), in single-blind (investigator and occupational therapist " 1 " do not know the type of rehabilitation performed). Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- mirror therapy and bimanual rehabilitation exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Nov 2017
- 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
- Unilateral spastic cerebral palsy as defined by SCPE (Surveillance of Cerebral Palsy in Europe)
- Aged 7 to 17 years
- MACS (Manual Ability Classification System) 1 to 3
- Extension of the wrist more than 10°
- Free, informed and written consent of the parents
- Free, informed and written consent of the child
- affiliated, via his/her parents, to the Social Security regime
Who cannot join
- Other neuromuscular disorders known
- Cognitive impairment hampering the understanding of instructions
- Upper-limb pain (EVA score >3)
- Restriction of passive range of motion
- Visual impairment not allowing the visualization of the upper limb in the mirror
- Upper-limb Botulinum toxin injection in upper limb 6 months prior to inclusion
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized and comparative prospective test, monocentric and controlled (mirror therapy versus bimanual rehabilitation exercises), in single-blind (investigator and occupational therapist " 1 " do not know the type of rehabilitation performed).
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- mirror therapy, bimanual rehabilitation exercises
- Keywords
- unilateral cerebral palsy, children, upper-limb, mirror therapy, bimanual coordination, kinematics analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mirror therapyProcedure or surgery
During a session, the child performs a series of 10 single, bilateral and synchronous movements while viewing the reflected image
bimanual rehabilitation exercisesProcedure or surgery
During a session, the child performs a series of 10 single, bilateral and synchronous movements while watching his two hands
| Study group | Role | What they receive |
|---|---|---|
| mirror therapy | Experimental | 5 sessions mirror therapy 15 minutes per week for 5 weeks Receives: Procedure: mirror therapy |
| bimanual rehabilitation exercises | Placebo comparator | 5 sessions control therapy 15 minutes per week for 5 weeks Receives: Procedure: bimanual rehabilitation exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the AHA (Assisting Hand Assessment) score
Measured: 5 weeks
Secondary outcomes (4)
Evolution of the AHA score
a variance analysis using 2 factors (time, group) is used (between the onset and 5 weeks later, between the onset and 10 weeks later)
Measured: baseline, 5 weeks, 10 weeks
Measurement of the maximal grasp and pinch strength
with a Baseline dynamometer
Measured: baseline, 5 weeks, 10 weeks
Qualitative and quantitative measurement of movement
by a kinematic analysis via an Optitrack system
Measured: baseline, 5 weeks, 10 weeks
Measurement of the manual ability
by Abilhand-kids questionnaire
Measured: baseline, 5 weeks, 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startFeb 2014
- Primary completionNov 2016
- Study completionNov 2017
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 Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène HR Rauscent, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131909
- Sponsor's protocol ID
- 2013-A01325-40
- Acronym
- PC MIROIR
- Status last verified
- May 2023
- First submitted
- 28 Apr 2014
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Gaillard F, Cretual A, Cordillet S, Le Cornec C, Gonthier C, Bouvier B, Heyman R, Marleix S, Bonan I, Rauscent H. Kinematic motion abnormalities and bimanual performance in children with unilateral cerebral palsy. Dev Med Child Neurol. 2018 Aug;60(8):839-845. doi: 10.1111/dmcn.13774. Epub 2018 Apr 27.
PubMed 29701242
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PC MIROIR : Effects of Mirror Therapy in Children With Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02131909
- Acronym / sponsor ID
- PC MIROIR / 2013-A01325-40
- Conditions
- Hemiplegic Cerebral Palsy
- Keywords
- unilateral cerebral palsy, children, upper-limb, mirror therapy, bimanual coordination, kinematics analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 6 May 2014 (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.
This is a randomized and comparative prospective test, monocentric and controlled (mirror therapy versus bimanual rehabilitation exercises), in single-blind (investigator and occupational therapist " 1 " do not know the type of rehabilitation performed).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mirror therapy | Experimental | Procedure: mirror therapy5 sessions mirror therapy 15 minutes per week for 5 weeks |
| bimanual rehabilitation exercises | Placebo comparator | Procedure: bimanual rehabilitation exercises5 sessions control therapy 15 minutes per week for 5 weeks |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Unilateral spastic cerebral palsy as defined by SCPE (Surveillance of Cerebral Palsy in Europe)
- Aged 7 to 17 years
- MACS (Manual Ability Classification System) 1 to 3
- Extension of the wrist more than 10°
- Free, informed and written consent of the parents
Key exclusion criteria (6 listed)
- Other neuromuscular disorders known
- Cognitive impairment hampering the understanding of instructions
- Upper-limb pain (EVA score >3)
- Restriction of passive range of motion
- Visual impairment not allowing the visualization of the upper limb in the mirror
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 |
|---|---|---|
| mirror therapyDuring a session, the child performs a series of 10 single, bilateral and synchronous movements while viewing the reflected image | Procedure or surgery | mirror therapy |
| bimanual rehabilitation exercisesDuring a session, the child performs a series of 10 single, bilateral and synchronous movements while watching his two hands | Procedure or surgery | bimanual rehabilitation exercises |
Primary outcome
Measurement of the AHA (Assisting Hand Assessment) score
Time frame: 5 weeks
4 secondary outcomes
Evolution of the AHA score
Time frame: baseline, 5 weeks, 10 weeks
Measurement of the maximal grasp and pinch strength
Time frame: baseline, 5 weeks, 10 weeks
Qualitative and quantitative measurement of movement
Time frame: baseline, 5 weeks, 10 weeks
Measurement of the manual ability
Time frame: baseline, 5 weeks, 10 weeks
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 24 May 2023.
- Results publication: PubMed 29701242Gaillard F, Cretual A, Cordillet S, Le Cornec C, Gonthier C, Bouvier B, Heyman R, Marleix S, Bonan I, Rauscent H. Kinematic motion abnormalities and bimanual performance in children with unilateral cerebral palsy. Dev Med Child Neurol. 2018 Aug;60(8):839-845. doi: 10.1111/dmcn.13774. Epub 2018 Apr 27.
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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.
Hélène HR Rauscent principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mirror therapy and bimanual rehabilitation exercises in people with Hemiplegic Cerebral Palsy, run by Rennes 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 7 inclusion and 6 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 24 May 2023. 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. Some participants in this study may receive a placebo. 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?
Measurement of the AHA (Assisting Hand Assessment) score (time frame: 5 weeks). 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 NCT02131909, 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 24 May 2023.