Effects of Intensive Upper and Lower Limbs Motor Control Therapy in Cerebral Palsy Children

May 9, 2018 updated by: Isabel Rodriguez Costa, University of Alcala
The aim of the study is to determine the effetiveness of the intensive upper and lower limbs therapy to improve the funtional outcomes and to minimize ther energetic spendings during funtional activities in Cerebral Palsy patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of the study is to determine the effetiveness of the intensive upper and lower limbs therapy to improve the funtional outcomes and to minimize ther energetic spendings during funtional activities in Cerebral Palsy patients. Also to know paretns and caregivers perceptions.

Study Type

Interventional

Enrollment (Actual)

10

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
    • Madrid
      • Alcalá de Henares, Madrid, Spain, 28803
        • University

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

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Cerebral Palsy

Exclusion Criteria:

-

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intensive bimanual therapy
Ninety hours of intensive bimanual therapy
Other: Intensive bimanual therapy
Ninety hours of intensive bimanual therapy
Active Comparator: Neurodevelopmental treatment
Ninety hours of intensive neurodevelopmental therapy
Other: Intensive neurodevelopmental therapy
Ninety hours of intensive neurodevelopmental therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arm Funtion
Time Frame: 6 months
Assissting Hand Assessment Instrument (AHA)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Funtional Activity
Time Frame: 6 months
Jebsen Taylor Hand Funtion Test
6 months
Perception of performance in everyday living
Time Frame: 6 months
Canadian Occupational Performance Measure (COMP)
6 months

Collaborators and Investigators

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

Sponsor

University of Alcala

Collaborators

European University Spain

Investigators

  • Study Director: Andrew Gordon, PhD, Columbia Universuty

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 14, 2017

Primary Completion (Actual)

August 3, 2017

Study Completion (Actual)

February 3, 2018

Study Registration Dates

First Submitted

June 29, 2017

First Submitted That Met QC Criteria

May 9, 2018

First Posted (Actual)

May 11, 2018

Study Record Updates

Last Update Posted (Actual)

May 11, 2018

Last Update Submitted That Met QC Criteria

May 9, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-0066/16

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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