Clinical trial NCT02424526: Intensive Home-based Treadmill Training and Walking Attainment in Young Children With Cerebral Palsy
Official title: Intensive Home-based Treadmill Training and Walking Attainment in Young Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: cerebral palsy
treadmill training
walking
Lead sponsor: California State University, Sacramento
Sponsor class: OTHER
Collaborators: name: Seattle Children's Hospital
name: University of Puget Sound
name: Thrasher Research Fund
First posted: 2015-04-23
Enrollment: 19
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Gross Motor Function Measure Dimension E
timeFrame: assessed at 6 weeks, 1 month, 4 months from baseline
measure: Walking Activity Measured by StepWatch
timeFrame: StepWatch data was collected for all awake daytime hours over a 7 day period at study onset before treadmill training commences and at 6 weeks, 1 month, 4 months.
measure: Gross Motor Function Measure Dimension D
timeFrame: assessed at 6 weeks, 1 month, 4 months from baseline
Secondary outcomes:
measure: Pediatric Evaluation of Disability Index-Mobility Subscale
timeFrame: pre-intervention, at 6 weeks, at 1-month and at 4-months following the intervention
measure: Timed 10-meter Walk Test
timeFrame: assessed at 6 weeks, at 1-month and at 4-months following the intervention
measure: Peabody Developmental Motor Scales-2 -Locomotion Subscale
timeFrame: assessed at 6 weeks, at 1-month and at 4-months
measure: 1-minute Walk Test
timeFrame: assessed at 6 weeks, 1 month, 4 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Research Institute
state: Washington
city: Tacoma
country: United States
facility: University of the Puget Sound
state: Washington
Study officials:
affiliation: California State University, Sacramento
name: David Earwicker, BA,MA
role: STUDY_DIRECTOR
References:
citation: Mattern-Baxter K, Looper J, Zhou C, Bjornson K. Low-Intensity vs High-Intensity Home-Based Treadmill Training and Walking Attainment in Young Children With Spastic Diplegic Cerebral Palsy. Arch Phys Med Rehabil. 2020 Feb;101(2):204-212. doi: 10.1016/j.apmr.2019.09.015. Epub 2019 Nov 1.