Cerebral Palsy
Conditions
Keywords
cerebral palsy, treadmill training, walking
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.
Interventions
OTHERhome-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
DEVICETreadmill
Sponsors
Seattle Children's Hospital
University of Puget Sound
Thrasher Research Fund
California State University, Sacramento
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 3 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gross Motor Function Measure Dimension E | assessed at 6 weeks, 1 month, 4 months from baseline | 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. |
| Walking Activity Measured by StepWatch | 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. | 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. |
| Gross Motor Function Measure Dimension D | assessed at 6 weeks, 1 month, 4 months from baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Evaluation of Disability Index-Mobility Subscale | pre-intervention, at 6 weeks, at 1-month and at 4-months following the intervention | 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. |
| 1-minute Walk Test | assessed at 6 weeks, 1 month, 4 months | 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. |
| Timed 10-meter Walk Test | assessed at 6 weeks, at 1-month and at 4-months following the intervention | 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. |
| Peabody Developmental Motor Scales-2 -Locomotion Subscale | assessed at 6 weeks, at 1-month and at 4-months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High-intensity Group High-intensity engaged in treadmill training 10x/week for 6 weeks | 9 |
| Low-intensity Group Low-intensity engaged in treadmill training 2x/week for 6 weeks | 10 |
| Total | 19 |
Baseline characteristics
| Characteristic | High-intensity Group | Low-intensity Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 9 Participants | 10 Participants | 19 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized African-American | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 2 Participants | 5 Participants | 7 Participants |
| Region of Enrollment United States | 9 participants | 10 participants | 19 participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 10 |
| other Total, other adverse events | 0 / 9 | 0 / 10 |
| serious Total, serious adverse events | 0 / 9 | 0 / 10 |
Outcome results
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.
Time frame: assessed at 6 weeks, 1 month, 4 months from baseline
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| High-intensity Group | Gross Motor Function Measure Dimension D | 6 weeks | 5.11 score on a scale |
| High-intensity Group | Gross Motor Function Measure Dimension D | 1 month | 8.22 score on a scale |
| High-intensity Group | Gross Motor Function Measure Dimension D | 4 months | 12.67 score on a scale |
| Low-intensity Group | Gross Motor Function Measure Dimension D | 6 weeks | 5.30 score on a scale |
| Low-intensity Group | Gross Motor Function Measure Dimension D | 1 month | 8.72 score on a scale |
| Low-intensity Group | Gross Motor Function Measure Dimension D | 4 months | 12.94 score on a scale |
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.
Time frame: assessed at 6 weeks, 1 month, 4 months from baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High-intensity Group | Gross Motor Function Measure Dimension E | 6 weeks | 15.6 score on a scale | Standard Deviation 5.9 |
| High-intensity Group | Gross Motor Function Measure Dimension E | 1 month | 18.7 score on a scale | Standard Deviation 7.5 |
| High-intensity Group | Gross Motor Function Measure Dimension E | 4 months | 16.2 score on a scale | Standard Deviation 5.9 |
| Low-intensity Group | Gross Motor Function Measure Dimension E | 6 weeks | 12.7 score on a scale | Standard Deviation 9.7 |
| Low-intensity Group | Gross Motor Function Measure Dimension E | 1 month | 17.1 score on a scale | Standard Deviation 8.8 |
| Low-intensity Group | Gross Motor Function Measure Dimension E | 4 months | 14.1 score on a scale | Standard Deviation 7.7 |
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| High-intensity Group | Walking Activity Measured by StepWatch | 1 month | 83.33 minutes |
| High-intensity Group | Walking Activity Measured by StepWatch | 4 months | 132.00 minutes |
| High-intensity Group | Walking Activity Measured by StepWatch | 6 weeks | 39.43 minutes |
| Low-intensity Group | Walking Activity Measured by StepWatch | 6 weeks | 25.09 minutes |
| Low-intensity Group | Walking Activity Measured by StepWatch | 1 month | 18.01 minutes |
| Low-intensity Group | Walking Activity Measured by StepWatch | 4 months | 41.19 minutes |
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.
Time frame: assessed at 6 weeks, 1 month, 4 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| High-intensity Group | 1-minute Walk Test | 6 weeks | 8.28 meters |
| High-intensity Group | 1-minute Walk Test | 4 months | 15.37 meters |
| High-intensity Group | 1-minute Walk Test | 1 month | 12.38 meters |
| Low-intensity Group | 1-minute Walk Test | 6 weeks | 7.87 meters |
| Low-intensity Group | 1-minute Walk Test | 1 month | 9.48 meters |
| Low-intensity Group | 1-minute Walk Test | 4 months | 16.15 meters |
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.
Time frame: assessed at 6 weeks, at 1-month and at 4-months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| High-intensity Group | Peabody Developmental Motor Scales-2 -Locomotion Subscale | 6 weeks | 5.67 score on a scale |
| High-intensity Group | Peabody Developmental Motor Scales-2 -Locomotion Subscale | 1 month | 8.33 score on a scale |
| High-intensity Group | Peabody Developmental Motor Scales-2 -Locomotion Subscale | 4 months | 14.11 score on a scale |
| Low-intensity Group | Peabody Developmental Motor Scales-2 -Locomotion Subscale | 6 weeks | 6.70 score on a scale |
| Low-intensity Group | Peabody Developmental Motor Scales-2 -Locomotion Subscale | 1 month | 9.21 score on a scale |
| Low-intensity Group | Peabody Developmental Motor Scales-2 -Locomotion Subscale | 4 months | 13.99 score on a scale |
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.
Time frame: pre-intervention, at 6 weeks, at 1-month and at 4-months following the intervention
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| High-intensity Group | Pediatric Evaluation of Disability Index-Mobility Subscale | 6 weeks | 3.80 score on a scale |
| High-intensity Group | Pediatric Evaluation of Disability Index-Mobility Subscale | 1 month | 6.89 score on a scale |
| High-intensity Group | Pediatric Evaluation of Disability Index-Mobility Subscale | 4 months | 11.63 score on a scale |
| Low-intensity Group | Pediatric Evaluation of Disability Index-Mobility Subscale | 6 weeks | 5.44 score on a scale |
| Low-intensity Group | Pediatric Evaluation of Disability Index-Mobility Subscale | 1 month | 7.51 score on a scale |
| Low-intensity Group | Pediatric Evaluation of Disability Index-Mobility Subscale | 4 months | 14.00 score on a scale |
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.
Time frame: assessed at 6 weeks, at 1-month and at 4-months following the intervention
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| High-intensity Group | Timed 10-meter Walk Test | 4 months | -46.99 seconds |
| High-intensity Group | Timed 10-meter Walk Test | 1 month | -28.16 seconds |
| High-intensity Group | Timed 10-meter Walk Test | 6 weeks | -24.86 seconds |
| Low-intensity Group | Timed 10-meter Walk Test | 4 months | -38.80 seconds |
| Low-intensity Group | Timed 10-meter Walk Test | 1 month | -49.65 seconds |
| Low-intensity Group | Timed 10-meter Walk Test | 6 weeks | -36.23 seconds |