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

Primary Purpose

Cerebral Palsy

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

treadmill training

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral palsy, treadmill training

Eligibility Criteria

9 Months - 36 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

treadmill training

no treadmill training

Arm Description

children will receive home-based treadmill training with supervision from a physical therapist

children will not receive treadmill training

Outcomes

Primary Outcome Measures

Gross Motor Function Measure Dimension D and E

Secondary Outcome Measures

Peabody Developmental Motor Scales-2

timed 10 meter walk test

Pediatric Evaluation of Disability Inventory

Full Information

NCT ID

NCT01732731

First Posted

September 24, 2012

Last Updated

November 23, 2012

Sponsor

University of the Pacific

1. Study Identification

Unique Protocol Identification Number

NCT01732731

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

April 2009 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of the Pacific

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Palsy

Keywords

Cerebral palsy, treadmill training

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Non-Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

treadmill training

Arm Type

Experimental

Arm Description

children will receive home-based treadmill training with supervision from a physical therapist

Arm Title

no treadmill training

Arm Type

No Intervention

Arm Description

children will not receive treadmill training

Intervention Type

Other

Intervention Name(s)

treadmill training

Intervention Description

Home-based treadmill training will be administered to the children in the experimental group

Primary Outcome Measure Information:

Title

Gross Motor Function Measure Dimension D and E

Time Frame

up to 4-months post-intervention

Secondary Outcome Measure Information:

Title

Peabody Developmental Motor Scales-2

Time Frame

pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention

Title

timed 10 meter walk test

Time Frame

pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention

Title

Pediatric Evaluation of Disability Inventory

Time Frame

pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

9 Months

Maximum Age & Unit of Time

36 Months

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Katrin Mattern-Baxter

Organizational Affiliation

University of the Pacific

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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