Upper Limb Intensive Therapies in Babies With Unilateral Cerebral Palsy.

November 22, 2020 updated by: Rocio Palomo Carrión, CEU San Pablo University

Effects of Infant Constraint Induced Movement Therapy and Infant Bimanual Intensive Therapy in Unilateral Cerebral Palsy. A Randomized Controlled Trial.

mCIMT and BIT are therapies applied in children with hemiplegia which have a great evidence, but not in a early age. This research has the objective to know the effects of this therapies in infants diagnosed of infantile hemiplegia from 9 to 18 months applying 50 hours of dose for both interventions during 10 weeks, executing them at home by familes.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Infantile hemiplegia
  • Age from 9 months to 18 months.
  • No use of the affected upper limb

Exclusion Criteria:

  • Associated pathologies
  • Epilepsy no controlled with medicins
  • No collaborated families

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: infant cimt
Other: Infant BIT
Not use of unaffected hand containment. Both hand are use to improve the bimanual coordination
Other: Infant CIMT/BIT
Use unaffected hand containment in part of the intervention and then, both hands in bimanual activities without containment.
Other: Conventional therapy
Following the usual therapy in the baby.
Active Comparator: Infant BIT
Other: Infant CIMT/BIT
Use unaffected hand containment in part of the intervention and then, both hands in bimanual activities without containment.
Other: Conventional therapy
Following the usual therapy in the baby.
Other: infant cimt
use of unaffected hand containment to improve the use of affected hand with unimanual activities
Active Comparator: Infant CIMT/BIT
Other: Infant BIT
Not use of unaffected hand containment. Both hand are use to improve the bimanual coordination
Other: Conventional therapy
Following the usual therapy in the baby.
Other: infant cimt
use of unaffected hand containment to improve the use of affected hand with unimanual activities
Active Comparator: Conventional Therapy
Other: Infant BIT
Not use of unaffected hand containment. Both hand are use to improve the bimanual coordination
Other: Infant CIMT/BIT
Use unaffected hand containment in part of the intervention and then, both hands in bimanual activities without containment.
Other: infant cimt
use of unaffected hand containment to improve the use of affected hand with unimanual activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mini Assisting Hand Assesment
Time Frame: 10 weeks
Bimanual functional performance Assessment in children with hemiplegia from 8 to 18 months.
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction questionnaire for familes
Time Frame: 10 weeks
Descriptive questionnaire to obtain the adherence and satisfaction from families in this therapies.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CEU San Pablo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2019

Primary Completion (Anticipated)

January 18, 2021

Study Completion (Anticipated)

March 20, 2021

Study Registration Dates

First Submitted

November 3, 2020

First Submitted That Met QC Criteria

November 22, 2020

First Posted (Actual)

November 24, 2020

Study Record Updates

Last Update Posted (Actual)

November 24, 2020

Last Update Submitted That Met QC Criteria

November 22, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • infant CIMT/BIT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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