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
Sponsor:
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
  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 April 17, 2014