ClinicalTrials.gov
ClinicalTrials.gov Menu

New Perspectives in the Rehabilitation of Children With Motor Disorders : the Role of the Mirror Neuron System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01016496
Recruitment Status : Completed
First Posted : November 19, 2009
Last Update Posted : June 24, 2014
Sponsor:
Collaborators:
University of Parma
IRCCS Fondazione Stella Maris
Information provided by (Responsible Party):
Stefania Costi, University of Modena and Reggio Emilia

Brief Summary:
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 or disease Intervention/treatment Phase
Hemiplegia Cerebral Palsy Other: action observation therapy Other: repetition of gestures Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, 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
Study Start Date : September 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Assisting Hand Assessment [ Time Frame: T0, Tend, T2, T6 ]
  2. Jebsen-Taylor [ Time Frame: T0, Tend, T2, T6 ]
  3. Abilhand emikids [ Time Frame: T0, Tend, T2, T6 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01016496


Locations
Italy
Hospital of Parma
Parma, Italy, 43100
IRCCS Stella Maris
Pisa, Italy
Azienda Santa Maria Nuova -
Reggio Emilia, Italy, 42100
Sponsors and Collaborators
Stefania Costi
University of Parma
IRCCS Fondazione Stella Maris
Investigators
Principal Investigator: Rizzolatti Giacomo, Professor University of Parma
Study Director: Ferrari Adriano, Professor University of Modena and Reggio Emilia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stefania Costi, technician, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier: NCT01016496     History of Changes
Other Study ID Numbers: MIRROR_UDGEE_09
First Posted: November 19, 2009    Key Record Dates
Last Update Posted: June 24, 2014
Last Verified: June 2014

Keywords provided by Stefania Costi, 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
Motor Disorders
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms
Mental Disorders