Intensive Home-based Treadmill Training and Walking Attainment in Young Children With Cerebral Palsy

California State University, Sacramento

Status

Completed

Conditions

Cerebral Palsy

Treatments

Device: Treadmill

Other: home-based treadmill training

Study type

Interventional

Funder types

Other

Identifiers

NCT02424526

13-14-156

Details and patient eligibility

About

This study is designed to find the optimal dosage of home-based treadmill training needed to accelerate walking onset and to examine the long-term effects on the child's walking activity.

Full description

The purpose of this study is to determine optimal parameters for dosing home-based treadmill training by comparing high-intensity (5 days/week, twice daily for 10-20 min for 6 weeks) to low-intensity (2 days/week, once daily for 10-20 minutes for 6 weeks) treadmill training; and to compare the effects of high- versus low-intensity treadmill training on walking attainment and overall walking activity in young children with cerebral palsy.

Hypotheses

A more intensive protocol of treadmill training will increase walking onset in young children with CP.
A more intensive protocol of treadmill training will increase overall walking activity in young children with CP.

Specific Aims

To determine optimal parameters for dosing home-based treadmill training by comparing high-intensity to low-intensity home-based treadmill training.
To compare the effects of high- versus low-intensity treadmill training on walking onset and overall walking activity.

Study design •Prospective randomized controlled trial

Study population

•Two groups of 12 children with CP under the age of 3 years and are not walking yet will receive either home-based high-intensity treadmill training or low-intensity treadmill training. The children will be assessed before, immediately after, at 1-month and at 4-months following the intervention via standardized outcome measures.

Enrollment

19 patients

Sex

All

Ages

1 to 3 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Signs of walking readiness as demonstrated by the ability to sit for 30 seconds when placed and to take 5 to 7 steps when supported at the trunk or arms.
Because young children often are not formally diagnosed with CP until 2 years of age, we will include children
- who show bilateral impairment (i.e. diplegia and quadriplegia, but not hemiplegia)
- who demonstrate upper motor neuron signs (i.e. spasticity and/or hyperreflexia)
- who have been identified as high-risk for a motor disability by a physician

Exclusion criteria