Effects of Intensive Locomotor Treadmill Training on Gross Motor Function in Young Children With Neuromotor Impairment

November 23, 2012 updated by: University of the Pacific
The purpose of this project is to examine if early exposure to intensive, short-term locomotor treadmill training (LT) in young children with neuromotor impairment will help develop walking skills earlier, decrease the amount of outside assistance needed (such as a walker or crutches) as compared to children with neuromotor impairment who receive traditional physical therapy intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

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 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • a diagnosis of CP with GMFCS levels I and II
  • ages 9 to 36 months
  • the ability to sit for at least 30 seconds unsupported in ring-sitting or W-sitting
  • the ability to take ten consecutive steps when held on hands

Exclusion Criteria:

  • a diagnosis of a genetic syndrome
  • independent ambulation without an assistive device
  • previous or current use of treadmill intervention during physical therapy
  • a medical contraindication for standing or walking defined by the physician 5) uncontrolled seizures
  • a history of orthopedic surgery
  • use of medication to control spasticity in the past 6 months

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treadmill training
children will receive home-based treadmill training with supervision from a physical therapist
Other: treadmill training
Home-based treadmill training will be administered to the children in the experimental group
No Intervention: no treadmill training
children will not receive treadmill training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Gross Motor Function Measure Dimension D and E
Time Frame: up to 4-months post-intervention
up to 4-months post-intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Peabody Developmental Motor Scales-2
Time Frame: pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention
pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention
timed 10 meter walk test
Time Frame: pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention
pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention
Pediatric Evaluation of Disability Inventory
Time Frame: pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention
pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention

Collaborators and Investigators

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

Sponsor

University of the Pacific

Investigators

  • Principal Investigator: Katrin Mattern-Baxter, University of the Pacific

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

April 1, 2009

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

September 24, 2012

First Submitted That Met QC Criteria

November 23, 2012

First Posted (Estimate)

November 26, 2012

Study Record Updates

Last Update Posted (Estimate)

November 26, 2012

Last Update Submitted That Met QC Criteria

November 23, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-97
  • 527109 (Other Grant/Funding Number: Am PhysTherapy Assoc. Pediatric Research Grant 527109)

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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