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| Name | Class |
|---|---|
| Seattle Children's Hospital | OTHER |
| University of Puget Sound | OTHER |
| Thrasher Research Fund | OTHER |
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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.
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
Specific Aims
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high-intensity group | Active Comparator | Children will engage in home-based treadmill training 5 days/week, twice daily for 10-20 min for 6 weeks |
|
| low-intensity group | Active Comparator | Children will engage in home-based treadmill training 2 days/week, once daily for 10-20 minutes for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| home-based treadmill training | Other | the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Earwicker, BA,MA | California State University, Sacramento | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Children's Research Institute | Seattle | Washington | 98145 | United States | ||
| University of the Puget Sound |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31678223 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | High-intensity Group | Children will engage in home-based treadmill training 5 days/week, twice daily for 10-20 min for 6 weeks 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 Treadmill |
| FG001 | Low-intensity Group | Children will engage in home-based treadmill training 2 days/week, once daily for 10-20 minutes for 6 weeks 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 Treadmill |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The data from one participant could not be analyzed after post-test due to Botox injections.
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| ID | Title | Description |
|---|---|---|
| BG000 | High-intensity Group | High-intensity engaged in treadmill training 10x/week for 6 weeks |
| BG001 | Low-intensity Group | Low-intensity engaged in treadmill training 2x/week for 6 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | assessed at 6 weeks, 1 month, 4 months from baseline |
|
pre-intervention, at 6 weeks, at 1-month and at 4-months following the intervention.
fatigue, injury, fall, parent-reported or observed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High-intensity Group | treadmill training 10x/week | 0 |
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Power analysis was carried out to determine the sample size, however the population for the basis of power analysis was not as homogeneous as the subjects in this study. Not all outcome measures could be blinded.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katrin Mattern-Baxter, PT, DPT | Sacramento State | 19162785766 | kbaxter@csus.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 29, 2014 | Apr 27, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D005080 | Exercise Test |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Treadmill | Device |
|
| assessed at 6 weeks, 1 month, 4 months from baseline |
| pre-intervention, at 6 weeks, at 1-month and at 4-months following the intervention |
| 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 |
| 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 |
| 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 |
| Tacoma |
| Washington |
| 98416 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Children will engage in home-based treadmill training 5 days/week, twice daily for 10-20 min for 6 weeks 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 Treadmill |
| OG001 | Low-intensity Group | Children will engage in home-based treadmill training 2 days/week, once daily for 10-20 minutes for 6 weeks 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 Treadmill |
|
|
| 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. | Posted | Mean | 95% Confidence Interval | minutes | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 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. | Posted | Mean | 95% Confidence Interval | seconds | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 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. | Posted | Mean | 95% Confidence Interval | meters | assessed at 6 weeks, 1 month, 4 months |
|
|
|
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Low-intensity Group | treadmill training 2x/week | 0 | 10 | 0 | 10 | 0 | 10 |
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| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D008919 | Investigative Techniques |
| 4 months |
|
| 4 months |
|
| 4 months |
|
| 4 months |
|
| 4 months |
|
| 4 months |
|