Constraint Induced Movement Therapy on Infantile Hemiplegia

NCT ID: NCT02178371

Last Updated: 2020-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2019-12-31

Brief Summary

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The purpose of this study is to assess the functionality of the affected upper limb in infantile hemiplegia by applying a protocol of modified constraint-induced movement therapy.

Detailed Description

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Conditions

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Hemiplegia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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UTWC (control group)

the control group performs the same tasks than the experimental group, but without healthy hand constraint/containment.

Group Type EXPERIMENTAL

Unimanual therapy without constraint UTWC

Intervention Type PROCEDURE

affected upper limb use without constraint of healthy hand

mCIMT

The study is conducted over a period of 5 weeks of treatment, using a movement restriction time healthy upper extremity of 2 hours daily.

The restriction applied in the study is performed with the closed hand position and thumb inside the fist through a transparent film that reaches the wrist joint.

In periods mCIMT, monitored the activities designed to enhance their functionality, based on motivation, avoiding frustrations are made.

Group Type EXPERIMENTAL

mCIMT

Intervention Type PROCEDURE

affected upper limb use with constraint of the healthy hand

Interventions

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mCIMT

affected upper limb use with constraint of the healthy hand

Intervention Type PROCEDURE

Unimanual therapy without constraint UTWC

affected upper limb use without constraint of healthy hand

Intervention Type PROCEDURE

Other Intervention Names

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Modified constraint-induced movement therapy

Eligibility Criteria

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Inclusion Criteria

* Children's Hemiplegia Medical diagnosis.
* Aged between 4 and 8 years.
* Lack of activity of the affected upper extremity.
* Overcoming 10th extension at the metacarpophalangeal and interphalangeal joint.
* Complete the 20 º of wrist extension of the affected upper extremity.
* Adequate cognitive development to understand verbal commands given for the execution of tasks.
* Cooperation in the execution of tasks.

Exclusion Criteria

* To Have vision problems that prevent them from carrying out the intervention.
* Having significant balance changes that endanger the child fall to bring a restriction in the affected upper limb.
* Submit uncontrolled seizures.
* To Have received botulinum toxin prior to 6 months prior to the intervention.
Minimum Eligible Age

4 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CEU San Pablo University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rocio Palomo Carrión, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

San Pablo CEU University

Francisco García-Muro SAn José, PhD, PT

Role: STUDY_DIRECTOR

San Pablo CEU University

Locations

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San Pablo CEU University

Boadilla del Monte, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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CEU-006

Identifier Type: -

Identifier Source: org_study_id

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