Treadmill Training in Infants At-Risk for Neuromotor Delay

Not Applicable

Completed

• Conditions: Infant born with low birth weight (<1500g).; Periventricular leukomalacia.; Hypoxic-ischemic encephalopathy.; Neonatal seizures.; Neurodevelopmental delay.; Physical Medicine / Rehabilitation - Physiotherapy; Neurological - Other neurological disorders

• Registration Number: ACTRN12612001060831
• Lead Sponsor: Michigan University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Mild to moderate hypo/hypertonia or developmental delay when examined by their pediatrician; no congenital musculoskeletal deficits or other genetic disorders.

Exclusion Criteria

Severe hypo/hypertonia, genetic disorders such as spina bifida or Down syndrome, and genetic musculoskeletal deficits.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome 1: Age of onset of independent walking.[Timepoint: whenever families reported their infants being able to take 3 steps over ground.];Primary outcome 2: percent of alternating steps.[Timepoint: monthly from starting the training or entering the study until walking onset (termination of intervention), and 6 months follow-up for gait analysis.];Primary outcome 3: percent of toe contact (Video analysis of foot placement at the initiation of the stance phase in the treadmill step).[Timepoint: monthly from starting the training or entering the study until walking onset (termination of intervention), and 6 months follow-up for gait analysis.]

Secondary Outcome Measures

Name	Time	Method
Secondary outcome 1: Gross Motor Function Measure[Timepoint: Termination of the intervention: when the infant was observed walking 3 independent steps over ground. Same timepoint for the control group.];Secondary outcome 2: Motor development (Bayley motor)[Timepoint: Termination of the intervention: when the infant was observed walking 3 independent steps over ground. Same timepoint for the control group.];Secondary outcome 3: Cognitive development (Bayley mental)[Timepoint: Termination of the intervention: when the infant was observed walking 3 independent steps over ground. Same timepoint for the control group.];Secondary outcome 4: Spasticity (Ashworth)[Timepoint: Termination of the intervention: when the infant was observed walking 3 independent steps over ground. Same timepoint for the control group.]