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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014