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Clinical Trials/NCT01732731
NCT01732731CompletedNot Applicable

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

University of the Pacific0 sites12 target enrollmentStarted: April 1, 2009Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
12
Primary Endpoint
Gross Motor Function Measure Dimension D and E
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
9 Months to 36 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

treadmill training

Experimental

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

Intervention: treadmill training (Other)

no treadmill training

No Intervention

children will not receive treadmill training

Outcomes

Primary Outcomes

Gross Motor Function Measure Dimension D and E

Time Frame: up to 4-months post-intervention

Secondary Outcomes

  • Peabody Developmental Motor Scales-2(pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention)
  • timed 10 meter walk test(pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention)
  • Pediatric Evaluation of Disability Inventory(pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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