- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01016496
New Perspectives in the Rehabilitation of Children With Motor Disorders : the Role of the Mirror Neuron System
June 23, 2014 updated by: Stefania Costi
Rehabilitation Strategies in Children With Neuro-motor Disorders Due to the Impairment of the Central Nervous System or the Peripheral Nervous System
Evidence exists that the activation of actions activates the same cortical motor areas that are involved in the performance of the observed actions.
The neural substrate for this phenomena is the mirror neuron system.
It is generally assumed that mirror neurons have a basic role in understanding the intentions of others and in imitation learning.
There is evidence that action observation has a positive effect on rehabilitation of motor disorders after stroke.
The aim of this study is to demonstrate that action observation followed by the repetition of the actions previously observed has a positive impact on rehabilitation of the upper limb in children affected by hemiplegia as a consequence of Cerebral Palsy.
In particular, the purpose is to assess if mirror neurons could improve the amount, the quality and the velocity of movements and the cooperation between the two upper extremities.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Parma, Italy, 43100
- Hospital of Parma
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Pisa, Italy
- IRCCS Stella Maris
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Reggio Emilia, Italy, 42100
- Azienda Santa Maria Nuova -
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- children with hemiplegia and
- Melbourne assessment > 50 points
Exclusion Criteria:
- inability to collaborate
- pharmacoresistant epilepsy
- inability to imitate gestures
- sensitivity disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Action observation plus repetition
Observation of actions and repetition of the same actions
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15 consecutive sessions of 18 minutes, plus repetition
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Active Comparator: repetition only
repetition of gestures
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15 consecutive session of visual games, plus repetition of gestures
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Melbourne Assessment of unilateral limb function
Time Frame: T0=baseline, Tend (week three) , T2(two months) T6months (six months after the completion of the training)
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T0=baseline, Tend (week three) , T2(two months) T6months (six months after the completion of the training)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assisting Hand Assessment
Time Frame: T0, Tend, T2, T6
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T0, Tend, T2, T6
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Jebsen-Taylor
Time Frame: T0, Tend, T2, T6
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T0, Tend, T2, T6
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Abilhand emikids
Time Frame: T0, Tend, T2, T6
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T0, Tend, T2, T6
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rizzolatti Giacomo, Professor, University of Parma
- Study Director: Ferrari Adriano, Professor, University of Modena and Reggio Emilia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sgandurra G, Biagi L, Fogassi L, Ferrari A, Sicola E, Guzzetta A, Tosetti M, Cioni G. Reorganization of action observation and sensory-motor networks after action observation therapy in children with congenital hemiplegia: A pilot study. Dev Neurobiol. 2020 Sep;80(9-10):351-360. doi: 10.1002/dneu.22783. Epub 2020 Oct 28.
- Sgandurra G, Ferrari A, Cossu G, Guzzetta A, Biagi L, Tosetti M, Fogassi L, Cioni G. Upper limb children action-observation training (UP-CAT): a randomised controlled trial in hemiplegic cerebral palsy. BMC Neurol. 2011 Jun 28;11:80. doi: 10.1186/1471-2377-11-80.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
November 18, 2009
First Submitted That Met QC Criteria
November 18, 2009
First Posted (Estimate)
November 19, 2009
Study Record Updates
Last Update Posted (Estimate)
June 24, 2014
Last Update Submitted That Met QC Criteria
June 23, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MIRROR_UDGEE_09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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