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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of the Pacific
ClinicalTrials.gov Identifier:
NCT01732731
First received: September 24, 2012
Last updated: November 23, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Cerebral Palsy
 Other: treadmill training

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Intensive Locomotor Treadmill Training on Gross Motor Function in Young Children With Neuromotor Impairment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of the Pacific:

Primary Outcome Measures:
  • Gross Motor Function Measure Dimension D and E [ Time Frame: up to 4-months post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Peabody Developmental Motor Scales-2 [ Time Frame: pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention ] [ Designated as safety issue: No ]
  • timed 10 meter walk test [ Time Frame: pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention ] [ Designated as safety issue: No ]
  • Pediatric Evaluation of Disability Inventory [ Time Frame: pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: April 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   9 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732731

Sponsors and Collaborators
University of the Pacific
Investigators
Principal Investigator: Katrin Mattern-Baxter University of the Pacific
  More Information

No publications provided

Responsible Party: University of the Pacific
ClinicalTrials.gov Identifier: NCT01732731     History of Changes
Other Study ID Numbers: 09-97, 527109
Study First Received: September 24, 2012
Last Updated: November 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of the Pacific:
Cerebral palsy
treadmill training

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on June 17, 2013