Intensive Therapies in Children With Hemiplegia (CIMT/BIT)

November 2, 2020 updated by: Rocío Palomo Carrión, University of Salamanca

Modified Constraint Induced Movement Therapy and Bimanual Intensive Therapy in Children With Hemiplegia. Comparative Study

This is a comparative study where two protocols of intensive therapies will be applied to study the improvements in the functional performance of the affected upper limb of children with hemiparesis and check whether to increase their quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

the intervention protocols combine different doses of intensive therapy, being 80 hours of modified constraint induced movement therapy followed by 20 hours for protocol 1 and protocol 2 would be the application of protocol 1 inverted, with this, the investigators want to compare how both protocols interfere in the function of the affected upper limb of children with different levels of bimanual functional performance.

Study Type

Interventional

Enrollment (Actual)

41

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 Locations

  • Spain
    • Toledo
      • Torrijos, Toledo, Spain, 45500
        • Rocío Palomo Carrión

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

5 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children diagnosed with Unilateral Infantile Cerebral Palsy, Congenital Infantile Hemiparesis.
  • Ages between 5 to 10 years.
  • Levels of I-III within the , manual ability classification system, MACS.
  • Levels of I-III within the gross motor function classification system, GMFCS

Exclusion Criteria:

- Diseases not associated with infantile hemiparesis.

  • Low cognitive level to understand the execution of activities.
  • Surgeries of the upper extremity during the 6 months prior to the intervention.
  • Structured contractures in the affected upper extremity that cause functional impotence.
  • Botulinum toxin two months prior to the intervention and application of it during the treatment.
  • Epilepsy not controlled pharmacologically

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: low performance group 1
Protocol 1 will be the intervention administered with 80 h modified constraint induced movement therapy and 20 h bimanual intensive therapy
Combination product: intensive therapies(CIMT/BIT): protocol 1 or protocol 2

The therapies applied in both protocols are intensive therapies that allow the execution of unimanual activities or bimanual activities with the affected upper limb with different doses.

the protocols were carried out at home through the family
Experimental: low performance group 2
Protocol 2 will be the intervention administered with 80h bimanual intensive therapy and 20h modified constraint induced movement therapy
Combination product: intensive therapies(CIMT/BIT): protocol 1 or protocol 2

The therapies applied in both protocols are intensive therapies that allow the execution of unimanual activities or bimanual activities with the affected upper limb with different doses.

the protocols were carried out at home through the family
Experimental: moderate-high performance group1
Protocol 1 will be the intervention administered with 80 h modified constraint induced movement therapy and 20 h bimanual intensive therapy
Combination product: intensive therapies(CIMT/BIT): protocol 1 or protocol 2

The therapies applied in both protocols are intensive therapies that allow the execution of unimanual activities or bimanual activities with the affected upper limb with different doses.

the protocols were carried out at home through the family
Experimental: moderate-high performance group 2
Protocol 2 will be the intervention administered with 80h bimanual intensive therapy and 20h modified constraint induced movement therapy
Combination product: intensive therapies(CIMT/BIT): protocol 1 or protocol 2

The therapies applied in both protocols are intensive therapies that allow the execution of unimanual activities or bimanual activities with the affected upper limb with different doses.

the protocols were carried out at home through the family

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bimanual functional performance, "change" is being assessed
Time Frame: 4 assessments will be carried out in the research in 10 weeks
use of the affected upper extremity of spontaneous character during bimanual activities. It is used the AHA assessment to measure it.
4 assessments will be carried out in the research in 10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life ,"change" is being assessed
Time Frame: 4 assessments will be carried out in the research in 10 weeks
This measure will be assessed with the pedsQL questionnaire
4 assessments will be carried out in the research in 10 weeks

Collaborators and Investigators

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

Sponsor

University of Salamanca

Investigators

  • Principal Investigator: Rocío Palomo Carrión, Salamanca University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 15, 2018

Primary Completion (Actual)

November 25, 2018

Study Completion (Actual)

January 30, 2019

Study Registration Dates

First Submitted

March 1, 2018

First Submitted That Met QC Criteria

March 13, 2018

First Posted (Actual)

March 14, 2018

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • nº11, thesis SDDB USAL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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