Wheel Assisted Running Training (WART) in Children With Cerebral Palsy (WART)

July 24, 2009 updated by: Israel Sport Center for the Disabled

Wheel Assisted Running Training in Children With Cerebral Palsy: A Controlled Clinical Trial

The purpose is to evaluate the effects of adding a wheel assisted running training (WART) to a conventional mixed physical activity training (CT) program on walking and gross motor function in trained children with cerebral palsy (CP).

Method entails recruiting thirty children with CP (16 females, 14 males), with mean (SD) age 11.8 (3.5) and training experience 3.4 (3.5), years were assigned to either WART or CT groups. The energy Expenditure Index (EEI), the Gross Motor Function Measure 66 (GMFM), self-selected and fast walking velocity (SSV and FV, respectively), and cadence are administered by a trained physical therapist. The intervention period is six months, with two sessions per week.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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

  • Israel
      • Ramat Gan, Israel, 52535
        • Israel Sport Center for the Disabled

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 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • (a) medical diagnosis of cerebral palsy;
  • (b) ability to comprehend instructions in a group setting;
  • (c) no medical procedures involving the lower limbs (including casting and Botox injections) during the last six months prior to pre-testing;
  • (d) able to walk three minutes at a self paced speed;
  • (e) no seizures during the last year, and (f) functional performance levels between II-IV of the gross motor functional classification system (GMFCS)

Exclusion Criteria:

  • (a) GMFCS I or V;
  • (b) Not being able to comprehend or comply with instructions.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
walking velocity
Time Frame: six months
six months

Secondary Outcome Measures

Outcome Measure
Time Frame
Energy expenditure index
Time Frame: six months
six months

Collaborators and Investigators

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

Sponsor

Israel Sport Center for the Disabled

Collaborators

Tel-Aviv Sourasky Medical Center

Investigators

  • Study Director: Yeshayahu Hutzler, Ph.D, Israel Sport Center for the Disabled

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

September 1, 2004

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

July 24, 2009

First Submitted That Met QC Criteria

July 24, 2009

First Posted (Estimate)

July 27, 2009

Study Record Updates

Last Update Posted (Estimate)

July 27, 2009

Last Update Submitted That Met QC Criteria

July 24, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Revital123

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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