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Trial record 4 of 16 for:    cerebral palsy | United States, Washington

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by California State University, Sacramento
Sponsor:
Collaborators:
Seattle Children's Hospital
University of Puget Sound
Thrasher Research Fund
Information provided by (Responsible Party):
Katrin Mattern-Baxter, California State University, Sacramento
ClinicalTrials.gov Identifier:
NCT02424526
First received: April 16, 2015
Last updated: February 1, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention
Cerebral Palsy
Other: home-based treadmill training
Device: Treadmill

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intensive Home-based Treadmill Training and Walking Attainment in Young Children With Cerebral Palsy

Resource links provided by NLM:


Further study details as provided by California State University, Sacramento:

Primary Outcome Measures:
  • Change in time in 1-minute Walk Test from baseline [ Time Frame: pre-intervention, at 6 weeks, at 1-month and at 4-months following the intervention. ] [ Designated as safety issue: No ]
    The child's walking distance will be measured in meters over 1 minute at their self-selected walking speed if the child is able to walk with an assistive device.

  • change in score on Gross Motor Function Measure from baseline [ Time Frame: pre-intervention, at 6 weeks,, at 1-month and at 4-months following the intervention. ] [ Designated as safety issue: No ]
    The child's gross motor skills related to rolling, sitting, crawling, standing and walking will be assessed by observation.

  • Change in score on Peabody Developmental Motor Scales-2 from baseline [ Time Frame: pre-intervention, at 6 weeks, at 1-month and at 4-months following the intervention. ] [ Designated as safety issue: No ]
    The child's gross motor skills compared to children with typical development are assessed by observation.

  • Change in score in Functional Mobility Scale from baseline [ Time Frame: pre-intervention, at 6 weeks, at 1-month and at 4-months following the intervention. ] [ Designated as safety issue: No ]
    This scale is used to document the child's current mobility level and the amount required for walking at different distances. It is designed to rate a child's walking ability over household, classroom and community distances.

  • Change in time in Timed 10-meter Walk Test from baseline [ Time Frame: pre-intervention, at 6 weeks, at 1-month and at 4-months following the intervention. ] [ Designated as safety issue: No ]
    The child's walking speed will be recorded over 10 meters if the child is able to walk with an assistive device.

  • Change in score in Pediatric Evaluation of Disability Index from baseline [ Time Frame: pre-intervention, at 6 weeks, at 1-month and at 4-months following the intervention. ] [ Designated as safety issue: No ]
    The PEDI is a valid and reliable tool that provides an assessment of a child's functional status and performance.

  • Change in activity measured by StepWatch from baseline [ Time Frame: StepWatch data will be collected for all awake daytime hours over a 7 day period at study onset before treadmill training commences and at each of the post-intervention assessments (up to 4-months) ] [ Designated as safety issue: No ]
    StepWatch data records the child's walking activity.


Estimated Enrollment: 24
Study Start Date: July 2015
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: high-intensity group
Children will engage in home-based treadmill training 5 days/week, twice daily for 10-20 min for 6 weeks
Other: 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
Device: Treadmill
Active Comparator: low-intensity group
Children will engage in home-based treadmill training 2 days/week, once daily for 10-20 minutes for 6 weeks
Other: 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
Device: Treadmill

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

Ages Eligible for Study:   1 Year to 3 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02424526

Contacts
Contact: Katrin Mattern-Baxter, PT, DPT, PCS 916-278-5766 kbaxter@csus.edu
Contact: Leah Vargas leah.vargas@csus.edu

Locations
United States, Washington
Seattle Children's Research Institute Recruiting
Seattle, Washington, United States, 98145
Contact: Kristie Bjornson, PT, PhD    206-884-2066    kristie.bjornson@seattlechildrens.org   
Contact: Marissa Robertson    206 884 1245    Marissa.robertson@seattlechildrens.org   
University of the Puget Sound Recruiting
Tacoma, Washington, United States, 98416
Contact: Julia Looper, PT, PhD    253-223-5910    jlooper@ups.edu   
Contact: Mary Ramsey    253.879.3180    PT@pugetsound.edu   
Sponsors and Collaborators
California State University, Sacramento
Seattle Children's Hospital
University of Puget Sound
Thrasher Research Fund
Investigators
Study Director: David Earwicker, BA,MA California State University, Sacramento
  More Information

Responsible Party: Katrin Mattern-Baxter, PT, DPT, PCS, California State University, Sacramento
ClinicalTrials.gov Identifier: NCT02424526     History of Changes
Other Study ID Numbers: 13-14-156 
Study First Received: April 16, 2015
Last Updated: February 1, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by California State University, Sacramento:
cerebral palsy
treadmill training
walking

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on December 02, 2016