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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2018-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01732731

Cerebral Palsy

COMPLETED NA

Effects of Treadmill Training and Whole-body Vibration in Children With Cerebral Palsy

NCT04630392

Cerebral Palsy

RECRUITING NA

Power Training Combined With Interval Treadmill Training

NCT03625570

Cerebral Palsy Central Nervous System Diseases Brain Damage, Chronic

COMPLETED NA

Short-Burst Interval Treadmill Training Cerebral Palsy

NCT04026295

Cerebral Palsy

ACTIVE_NOT_RECRUITING NA

Cerebral Palsy: Short-burst Interval Training

NCT03373890

Cerebral Palsy Spastic Diplegia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebral Palsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

high-intensity group

Children will engage in home-based treadmill training 5 days/week, twice daily for 10-20 min for 6 weeks

Group Type ACTIVE_COMPARATOR

home-based treadmill training

Intervention Type OTHER

the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist

Treadmill

Intervention Type DEVICE

low-intensity group

Children will engage in home-based treadmill training 2 days/week, once daily for 10-20 minutes for 6 weeks

Group Type ACTIVE_COMPARATOR

home-based treadmill training

Intervention Type OTHER

the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist

Treadmill

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

home-based treadmill training

the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist

Intervention Type OTHER

Treadmill

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* a history of uncontrolled seizures
* a diagnosis of a genetic disorder
* cardiac or orthopedic contraindications for standing and walking
* orthopedic surgery in the past 6 months
* use of spasticity-reducing medication or Botox injections in the past 6 months

Minimum Eligible Age

1 Year

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No