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

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ClinicalTrials.gov Identifier: NCT01732731
Recruitment Status : Completed
First Posted : November 26, 2012
Last Update Posted : November 26, 2012
Sponsor:
Information provided by (Responsible Party):
University of the Pacific

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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Other: treadmill training Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Intensive Locomotor Treadmill Training on Gross Motor Function in Young Children With Neuromotor Impairment
Study Start Date : April 2009
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cerebral Palsy
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Gross Motor Function Measure Dimension D and E [ Time Frame: up to 4-months post-intervention ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   9 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01732731


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

Responsible Party: University of the Pacific
ClinicalTrials.gov Identifier: NCT01732731     History of Changes
Other Study ID Numbers: 09-97
527109 ( Other Grant/Funding Number: Am PhysTherapy Assoc. Pediatric Research Grant 527109 )
First Posted: November 26, 2012    Key Record Dates
Last Update Posted: November 26, 2012
Last Verified: November 2012

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