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

• Sponsor: University of the Pacific (Other)
• Overall Status: Completed
• CT.gov ID: NCT01732731
• Collaborator: (none)
• Enrollment: 12
• Arms: 2
• Duration (Months): 41

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Apr 1, 2009
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Gross Motor Function Measure Dimension D and E [up to 4-months post-intervention]

Secondary Outcome Measures

1. Peabody Developmental Motor Scales-2 [pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention]

2. timed 10 meter walk test [pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention]

3. Pediatric Evaluation of Disability Inventory [pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Months to 36 Months
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of the Pacific

Investigators

• Principal Investigator: Katrin Mattern-Baxter, University of the Pacific

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of the Pacific
• ClinicalTrials.gov Identifier: NCT01732731
• Other Study ID Numbers: 09-97; 527109
• First Posted: Nov 26, 2012
• Last Update Posted: Nov 26, 2012
• Last Verified: Nov 1, 2012

• Keywords provided by University of the Pacific: Cerebral palsy; treadmill training
• Additional relevant MeSH terms: Cerebral Palsy

Study Results

No Results Posted as of Nov 26, 2012