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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01732731
• Other study ID #: 09-97
• Secondary ID: 527109
• Status: Completed
• Phase: N/A
• First received: September 24, 2012
• Last updated: November 23, 2012
• Start date: April 2009
• Est. completion date: September 2012

Study information

• Verified date: November 2012
• Source: University of the Pacific
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Months to 36 Months

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• treadmill training
Home-based treadmill training will be administered to the children in the experimental group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of the Pacific

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gross Motor Function Measure Dimension D and E		up to 4-months post-intervention	No
Secondary	Peabody Developmental Motor Scales-2		pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention	No
Secondary	timed 10 meter walk test		pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention	No
Secondary	Pediatric Evaluation of Disability Inventory		pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention	No