Cerebral Palsy Clinical Trial
Official title:
Intensive Home-based Treadmill Training and Walking Attainment in Young Children With Cerebral Palsy
NCT number | NCT02424526 |
Other study ID # | 13-14-156 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2015 |
Est. completion date | September 2018 |
Verified date | June 2020 |
Source | California State University, Sacramento |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 19 |
Est. completion date | September 2018 |
Est. primary completion date | September 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 3 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Seattle Children's Research Institute | Seattle | Washington |
United States | University of the Puget Sound | Tacoma | Washington |
Lead Sponsor | Collaborator |
---|---|
California State University, Sacramento | Seattle Children's Hospital, Thrasher Research Fund, University of Puget Sound |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gross Motor Function Measure Dimension E | The Gross Motor Function Measure is a criterion-referenced test of gross motor function for children with cerebral palsy ages 5 months to 15 years. It contains 5 Dimensions (A-E). Dimension E is related to the child's gross motor skills related to walking, running and jumping and is assessed by observation. Dimension E contains 24 gross motor skills. Each of these motor skills is rated either 0 (does not initiate), 1(initiates), 2 (partially completes), 3 (completes) or NT( not tested). The total possible Dimension E score is 72 with a range of 0-72. Scores can be converted into a percent score by dividing the child's achieved points by the number of possible points. Higher scores and a higher percentage indicate better performance in walking, running and jumping. Change from baseline in total points, not in percentage, is reported. | assessed at 6 weeks, 1 month, 4 months from baseline | |
Primary | Walking Activity Measured by StepWatch | StepWatch data records the child's walking activity in minutes/day. It is collected via an accelerometer attached to the distal leg and worn at all waking hours except during sleep and bath time.Higher numbers of active minutes indicate higher level of activity. Changes from baseline are reported. | 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. | |
Primary | Gross Motor Function Measure Dimension D | The Gross Motor Function Measure is a criterion-referenced test of gross motor function for children with cerebral palsy ages 5 months to 15 years. It contains 5 Dimensions (A-E).Dimension D is a test of gross motor function related to standing ability. The child's gross motor skills related to standing are assessed by observation. The test contains 13 gross motor skills. Each of these motor skills is rated either 0 (does not initiate), 1(initiates), 2 (partially completes), 3 (completes) or NT( not tested). The total possible Dimension D score is 39 with a range of 0-39. Scores can be converted into a percent score by dividing the child's achieved points by the number of possible points. Higher scores and a higher percentage indicate better performance in standing. Change from baseline in total points, not in percentage, is reported. | assessed at 6 weeks, 1 month, 4 months from baseline | |
Secondary | Pediatric Evaluation of Disability Index-Mobility Subscale | The Pediatric Evaluation of Disability Index is a valid and reliable tool that provides an assessment of a child's functional status and performance via observation and parent report.The Mobility Subscale examines the child's functional skills related to movement. There are a total of 13 motor categories on the Mobility Subscale, with 5 possible motor skills in each category, for a total of 65 distinct motor skills. Skills are marked as 0 (not observed) or 1 (observed) and added.There are a total of 65 possible points with a range of 0-65 points on the Mobility Subscale. Higher scores indicate greater function.Scores are reported as changes from baseline. | pre-intervention, at 6 weeks, at 1-month and at 4-months following the intervention | |
Secondary | Timed 10-meter Walk Test | The child's walking speed is recorded over 10 meters if the child is able to walk with or without an assistive device. The speed is timed and reported in seconds. Fewer seconds indicate a faster walking speed. Time in seconds is reported as change from baseline. | assessed at 6 weeks, at 1-month and at 4-months following the intervention | |
Secondary | Peabody Developmental Motor Scales-2 -Locomotion Subscale | Peabody Developmental Motor Scales-2 is a norm-referenced standardized test of gross and fine motor performance for children from birth through age 5.The Locomotion Subscale examines the ability of the child to move through space. It contains a total of 89 motor skills. The child is rated on each skill on a scale of 0 (unable), 1 (partial) or 2 (complete) and the scores are added for a total possible raw score of 178 and a range of 0-178. Higher raw scores indicate a better outcome.The raw scores can be converted to standard scores, age equivalents and percentiles Raw scores of the Locomotion subscale are reported based on changes from baseline. | assessed at 6 weeks, at 1-month and at 4-months | |
Secondary | 1-minute Walk Test | The child's walking distance is measured in meters over 1 minute at their self-selected walking speed if the child is able to walk with or without an assistive device.The walking distance is reported in meters. More meters indicate more distance covered. Values are reported in meters as changes from baseline. | assessed at 6 weeks, 1 month, 4 months |
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