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OpenTrials
Completed

NCT Number: NCT01732731

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

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.

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Key information

Age range

9 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treadmill training

Other

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

Primary outcomes

  1. Gross Motor Function Measure Dimension D and E

    Time frame: up to 4-months post-intervention

Secondary outcomes

  1. Peabody Developmental Motor Scales-2

    Time frame: pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention

  2. timed 10 meter walk test

    Time frame: pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention

  3. Pediatric Evaluation of Disability Inventory

    Time frame: pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention

Sponsors and collaborators

Lead sponsor

University of the Pacific

Other

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Nov 26, 2012
Registry last updated
Nov 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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