Back to results

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

Primary Purpose

Hemiplegia, Cerebral Palsy

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

action observation therapy

repetition of gestures

About this trial

This is an interventional treatment trial for Hemiplegia focused on measuring Cerebral Palsy, Mirror neurons, hemiplegia, action observation therapy, children affected by hemiplegia as a consequence of Cerebral Palsy

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

children with hemiplegia and
Melbourne assessment > 50 points

Exclusion Criteria:

inability to collaborate
pharmacoresistant epilepsy
inability to imitate gestures
sensitivity disorders

Sites / Locations

Hospital of Parma
IRCCS Stella Maris
Azienda Santa Maria Nuova -

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Action observation plus repetition

repetition only

Arm Description

Observation of actions and repetition of the same actions

repetition of gestures

Outcomes

Primary Outcome Measures

Melbourne Assessment of unilateral limb function

Secondary Outcome Measures

Assisting Hand Assessment

Jebsen-Taylor

Abilhand emikids

Full Information

NCT ID

NCT01016496

First Posted

November 18, 2009

Last Updated

June 23, 2014

Sponsor

Stefania Costi

Collaborators

University of Parma, IRCCS Fondazione Stella Maris

1. Study Identification

Unique Protocol Identification Number

NCT01016496

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Stefania Costi

Collaborators

University of Parma, IRCCS Fondazione Stella Maris

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemiplegia, Cerebral Palsy

Keywords

Cerebral Palsy, Mirror neurons, hemiplegia, action observation therapy, children affected by hemiplegia as a consequence of Cerebral Palsy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Action observation plus repetition

Arm Type

Experimental

Arm Description

Observation of actions and repetition of the same actions

Arm Title

repetition only

Arm Type

Active Comparator

Arm Description

repetition of gestures

Intervention Type

Other

Intervention Name(s)

action observation therapy

Intervention Description

15 consecutive sessions of 18 minutes, plus repetition

Intervention Type

Other

Intervention Name(s)

repetition of gestures

Intervention Description

15 consecutive session of visual games, plus repetition of gestures

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Assisting Hand Assessment

Time Frame

T0, Tend, T2, T6

Title

Jebsen-Taylor

Time Frame

T0, Tend, T2, T6

Title

Abilhand emikids

Time Frame

T0, Tend, T2, T6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: children with hemiplegia and Melbourne assessment > 50 points Exclusion Criteria: inability to collaborate pharmacoresistant epilepsy inability to imitate gestures sensitivity disorders

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rizzolatti Giacomo, Professor

Organizational Affiliation

University of Parma

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ferrari Adriano, Professor

Organizational Affiliation

University of Modena and Reggio Emilia

Official's Role

Study Director

Facility Information:

Facility Name

Hospital of Parma

City

Parma

ZIP/Postal Code

43100

Country

Italy

Facility Name

IRCCS Stella Maris

City

Pisa

Country

Italy

Facility Name

Azienda Santa Maria Nuova -

City

Reggio Emilia

ZIP/Postal Code

42100

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

32986904

Citation

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.

Results Reference

derived

PubMed Identifier

21711525

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs