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

NCT01732731 | Completed

• 2 other identifiers: 09-97527109
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cerebral Palsy

Keywords

Cerebral palsy; treadmill training

Outcome Measures

Primary Outcomes (1)

• Gross Motor Function Measure Dimension D and E

  up to 4-months post-intervention

Secondary Outcomes (3)

• 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

Study Arms (2)

treadmill training

EXPERIMENTAL

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

Other: treadmill training

no treadmill training

NO INTERVENTION

children will not receive treadmill training

Interventions

treadmill training OTHER

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

treadmill training

Eligibility Criteria

• Age: 9 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of the Pacific: lead

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Katrin Mattern-Baxter

  University of the Pacific

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2012
• First Posted: November 26, 2012
• Study Start: April 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: November 26, 2012

Record last verified: 2012-11