New Perspectives in the Rehabilitation of Children With Motor Disorders : the Role of the Mirror Neuron System
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Modena and Reggio Emilia.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Modena and Reggio Emilia
Collaborator:
University of Parma
Information provided by:
University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier:
NCT01016496
First received: November 18, 2009
Last updated: June 24, 2010
Last verified: June 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Hemiplegia Cerebral Palsy |
Other: action observation therapy Other: repetition of gestures |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Rehabilitation Strategies in Children With Neuro-motor Disorders Due to the Impairment of the Central Nervous System or the Peripheral Nervous System |
Resource links provided by NLM:
Further study details as provided by University of Modena and Reggio Emilia:
Primary Outcome Measures:
- 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) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Assisting Hand Assessment [ Time Frame: T0, Tend, T2, T6 ] [ Designated as safety issue: No ]
- Jebsen-Taylor [ Time Frame: T0, Tend, T2, T6 ] [ Designated as safety issue: No ]
- Abilhand emikids [ Time Frame: T0, Tend, T2, T6 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | November 2010 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Action observation plus repetition
Observation of actions and repetition of the same actions
|
Other: action observation therapy
15 consecutive sessions of 18 minutes, plus repetition
|
|
Active Comparator: repetition only
repetition of gestures
|
Other: repetition of gestures
15 consecutive session of visual games, plus repetition of gestures
|
Eligibility| Ages Eligible for Study: | 6 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- children with hemiplegia and
- Melbourne assessment > 50 points
Exclusion Criteria:
- inability to collaborate
- pharmacoresistant epilepsy
- inability to imitate gestures
- sensitivity disorders
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01016496
Contacts
| Contact: Adriano Ferrari, Professor | 0039052229 ext 6183 | adriano.ferrari@unimore.it |
| Contact: Stefania Costi, MSc. | 0039052252 ext 2441 | stefania.costi@unimore.it |
Locations
| Italy | |
| Hospital of Parma | Recruiting |
| Parma, Italy, 43100 | |
| Contact: Giuliana Bossi, BSc 0039052170 ext 2218 | |
| Sub-Investigator: Cossu Giuseppe, Professor | |
| Sub-Investigator: Giuliana Bossi, BSc | |
| IRCCS Stella Maris | Recruiting |
| Pisa, Italy | |
| Contact: Giovanni Cioni, Professor | |
| Principal Investigator: Giovanni Cioni, Professor | |
| Sub-Investigator: Giuseppina Sgandurra, MSc | |
| Azienda Santa Maria Nuova - | Recruiting |
| Reggio Emilia, Italy, 42100 | |
| Contact: Maria Cristina Filippi, BSc. 00390522296771 | |
| Principal Investigator: Ferrari Adriano, Professor | |
| Sub-Investigator: Maria Cristina Filippi, BSc | |
| Sub-Investigator: Stefania Costi, MSc. | |
Sponsors and Collaborators
University of Modena and Reggio Emilia
University of Parma
Investigators
| Principal Investigator: | Rizzolatti Giacomo, Professor | University of Parma |
| Study Director: | Ferrari Adriano, Professor | University of Modena and Reggio Emilia |
More Information
No publications provided by University of Modena and Reggio Emilia
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Prof. Giacomo Rizzolatti, University of Parma |
| ClinicalTrials.gov Identifier: | NCT01016496 History of Changes |
| Other Study ID Numbers: | MIRROR_UDGEE_09 |
| Study First Received: | November 18, 2009 |
| Last Updated: | June 24, 2010 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by University of Modena and Reggio Emilia:
|
Cerebral Palsy Mirror neurons hemiplegia action observation therapy children affected by hemiplegia as a consequence of Cerebral Palsy |
Additional relevant MeSH terms:
|
Cerebral Palsy Hemiplegia Brain Damage, Chronic Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Paralysis Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013