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| Name | Class |
|---|---|
| Louisiana State University Health Sciences Center in New Orleans | OTHER |
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This study examines the effect of short burst interval treadmill training in ambulatory children with cerebral palsy. Half the sample will receive 20 sessions of training over 4 weeks, while half will receive the training over 10 weeks.
Ambulatory children with cerebral palsy (CP) experience activity limitations which negatively influence their ability to physically participate in day to day life. Therefore, these children are at greater risk for inactivity and functional decline with age. In contrast, typically developing (TD) children engage in short bursts of intense physical activity interspersed with varying intervals of low and moderate intensity within their natural environment. These physical activity patterns are very different from adult patterns Despite these inherent differences, locomotor treadmill training (LTT) protocols designed to improve walking activity in children with CP simulate adult protocols, consisting of continuous low to moderate walking endurance activity. Body weight supported or robot assisted LTT is based on the underlying premise of modifying neural circuitry via spinal pathways. However, this type of training has not been shown to be more effective than other comparable interventions and presents with significant fiscal and logistical barriers to clinical translation.
This study will determine the effect of short-burst interval LTT without body weight support on the primary outcomes of walking performance and capacity and the secondary outcomes of day-to-day mobility based participation in children with CP with functional walking limitations. To identify key muscular mechanisms associated with improved walking mobility, the investigators will examine the effects of short-burst interval LTT on quadriceps muscle performance and architecture. Secondarily, the study team will collect preliminary data on two LTT dosing frequencies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short burst Interval Treadmill Training High Frequency | Experimental | Participants receive short burst interval treadmill training for a total of 20 sessions. They are randomized to receive it either 5x/week for 4 weeks |
|
| Short Burst Interval Treadmill Training Low Frequency | Active Comparator | Participants receive short burst interval treadmill training for a total of 20 sessions. They are randomized to receive it either 2x/week for 10 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short Burst Interval Locomotor Treadmill Training (SBLTT) | Behavioral | SBLTT consists of interval training consisting of short-bursts (30 seconds) of vigorous intensity locomotor treadmill training (LTT) alternating with low to moderate intensity LTT., |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Walking Performance High Versus Low Frequency SBLTT Groups | Average stride per day as measured by StepWatch accelerometry. StepWatch accelerometer stride counts per day ( minimum of 8 hrs/day wearing time) were averaged a crossed 5 days (4 weekdays and 1 weekend day) to create Average Strides/day variable | Change from baseline to immediately post SBLTT |
| Change in Community Walking Performance Intensity High Versus Low Frequency SBLTT Groups | Average Strides/day > 30 strides/min as measured by StepWatch accelerometry High Versus Low Frequency SBLTT Groups | Change from baseline to immediately post SBLTT |
| Change in Walking Capacity High Versus Low Frequency SBLTT Groups | Self selected walking speed as measured by 10 meter walk test High Versus Low Frequency SBLTT Groups | Change from baseline to immediately post SBLT. |
| Change in Walking Endurance- High Versus Low Frequency SBLTT Groups | Distance walked during the One Minute Walk Test High Versus Low Frequency SBLTT Groups | Change from baseline to immediately post SBLTT |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Muscle Performance -Power High Versus Low Frequency SBLTT Groups | Knee extensor muscle power - isotonic muscle power as measured by Biodex testing High Versus Low Frequency SBLTT Groups | Change from baseline to 6 weeks post SBLTT |
| Change in Muscle Performance - Strength High Versus Low Frequency SBLTT Groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Hendricks, PhD | Seattle Children's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Children's Research Institute | Seattle | Washington | 98115 | United States |
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In eligible if unable to walk at greater than their self selected walking speeds with orthotics on a treadmill.
Participants were recruited through a directed mailing to children with cerebral palsy receiving care at Seattle Children's Hospital between Sept 1, 2014 and June 30 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Short Burst Interval Treadmill Training High Frequency | All participants receive short burst interval treadmill training for a total of 20 sessions. They are randomized to receive 5x/week for 4 weeks. Short Burst Interval Locomotor Treadmill Training (SBLTT): SBLTT consists of interval training consisting of short-bursts (30 seconds) of vigorous intensity locomotor treadmill training (LTT) alternating with low to moderate intensity LTT. |
| FG001 | Short Burst Interval Treadmill Training Low Frequency | All participants receive short burst interval treadmill training for a total of 20 sessions. They are randomized to receive 2 x/week for10 weeks. Short Burst Interval Locomotor Treadmill Training (SBLTT): SBLTT consists of interval training consisting of short-bursts (30 seconds) of vigorous intensity locomotor treadmill training (LTT) alternating with low to moderate intensity LTT. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Short Burst Interval Treadmill Training High Frequency | All participants receive short burst interval treadmill training for a total of 20 sessions. They are randomized to receive it either 5x/week for 4 weeks Short Burst Interval Locomotor Treadmill Training (SBLTT): SBLTT consists of interval training consisting of short-bursts (30 seconds) of vigorous intensity locomotor treadmill training (LTT) alternating with low to moderate intensity LTT. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Change in Walking Performance High Versus Low Frequency SBLTT Groups | Average stride per day as measured by StepWatch accelerometry. StepWatch accelerometer stride counts per day ( minimum of 8 hrs/day wearing time) were averaged a crossed 5 days (4 weekdays and 1 weekend day) to create Average Strides/day variable | Change in average strides/day from baseline to immediately post SBLTT were compared between the high and low frequency groups/arms. | Posted | Mean | Standard Deviation | strides per day | Change from baseline to immediately post SBLTT |
|
Reported from consent/baseline to 6 week post intervention follow up which for high frequency group was approximately 4 months and for the low frequency group was 6 months
Severity coded Mild, moderate or severe Mild= inconvenience to day to day life Moderate= required medical attention Severe= Life threatening
Relationship to study:
Definitely Not Possibly Definitely Related
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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 Frequency 5x/Week | This group received short burst interval treadmill training 5x/week for total of 20 sessions |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild severity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | fall while walking down stairs at home not during treadmill training |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristie Bjornson, PT, PhD | SeattleChildrens | 206-884-2066 | kristie.bjornson@seattlechildrens.org |
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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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Pre/post intervention design with participants randomized to two different frequency of intervention
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Muscle function assessor masked to frequency group, Muscle architecture captured via ultrasound Community walking activity collected by accelerometry, thus non-human data collection
Knee extensor muscle strength - isometric muscle strength as measured by Biodex testing High Versus Low Frequency SBLTT Groups |
| Change from baseline to immediately post SBLTT |
| Change in Muscle Architecture-High Versus Low Frequency SBLTT Groups | Rectus femoris mid thigh cross-sectional area as measured by 2D B Mode Ultrasound High Versus Low Frequency SBLTT Groups | Change from baseline to immediately post SBLTT |
| Change in Muscle Architecture-hypertrophy High Versus Low Frequency SBLTT Groups | Rectus femoris mid thigh fascicle length as measured by 2D B Mode Ultrasound High Versus Low Frequency SBLTT Groups | Change from baseline to immediately post SBLTT |
| BG001 | Short Burst Interval Treadmill Training Low Frequency | All participants receive short burst interval treadmill training for a total of 20 sessions. They are randomized to receive it either 2x/week for 10 weeks Short Burst Interval Locomotor Treadmill Training (SBLTT): SBLTT consists of interval training consisting of short-bursts (30 seconds) of vigorous intensity locomotor treadmill training (LTT) alternating with low to moderate intensity LTT. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | All participants lived in western Washington state. | Number | participants |
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Received short burst interval training 2x week for total of 20 sessions |
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| Primary | Change in Community Walking Performance Intensity High Versus Low Frequency SBLTT Groups | Average Strides/day > 30 strides/min as measured by StepWatch accelerometry High Versus Low Frequency SBLTT Groups | Change in average strides/day > 30 strides/min as measured by StepWatch accelerometry for one side a cross 5 days (4 weekdays and 1 weekend day) | Posted | Mean | Standard Error | strides per day | Change from baseline to immediately post SBLTT |
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| Primary | Change in Walking Capacity High Versus Low Frequency SBLTT Groups | Self selected walking speed as measured by 10 meter walk test High Versus Low Frequency SBLTT Groups | Change in self selected walking speed between baseline and immediately post SBLTT was compared between the high and low frequency groups/arms. | Posted | Mean | Standard Deviation | meters per sec | Change from baseline to immediately post SBLT. |
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| Primary | Change in Walking Endurance- High Versus Low Frequency SBLTT Groups | Distance walked during the One Minute Walk Test High Versus Low Frequency SBLTT Groups | Change in distance walked in one minute between baseline and immediately post SBLTT compared between high and low frequency groups. | Posted | Mean | Standard Deviation | meters | Change from baseline to immediately post SBLTT |
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| Secondary | Change in Muscle Performance -Power High Versus Low Frequency SBLTT Groups | Knee extensor muscle power - isotonic muscle power as measured by Biodex testing High Versus Low Frequency SBLTT Groups | Posted | Mean | Standard Deviation | watts | Change from baseline to 6 weeks post SBLTT |
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| Secondary | Change in Muscle Performance - Strength High Versus Low Frequency SBLTT Groups | Knee extensor muscle strength - isometric muscle strength as measured by Biodex testing High Versus Low Frequency SBLTT Groups | Change in normalized isometric quadriceps strength as measured by Biodex, from baseline to immediately post SBLTT compared between high and low frequency groups/arms. | Posted | Mean | Standard Deviation | newton meters | Change from baseline to immediately post SBLTT |
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| Secondary | Change in Muscle Architecture-High Versus Low Frequency SBLTT Groups | Rectus femoris mid thigh cross-sectional area as measured by 2D B Mode Ultrasound High Versus Low Frequency SBLTT Groups | Change in rectus femoris cross sectional area as measured by 2D B Mode ultrasound, from baseline to immediately post SBLTT compared between high and low frequency groups/arms. | Posted | Mean | Standard Deviation | mm^2 | Change from baseline to immediately post SBLTT |
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| Secondary | Change in Muscle Architecture-hypertrophy High Versus Low Frequency SBLTT Groups | Rectus femoris mid thigh fascicle length as measured by 2D B Mode Ultrasound High Versus Low Frequency SBLTT Groups | Change in rectus femoris mid thigh fascicle length as measured by 2D B Mode ultrasound , from baseline to immediately post SBLTT compared between high and low frequency groups/arms. | Posted | Mean | Standard Deviation | millimeters | Change from baseline to immediately post SBLTT |
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| 0 |
| 6 |
| 0 |
| 6 |
| 2 |
| 6 |
| EG001 | Low Frequency 2x Week | Received short burst interval training 2x week for total of 20 sessions | 0 | 6 | 0 | 6 | 0 | 6 |
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| Mild possibly related to study | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | blister from new Ankle Foot Orthoses (AFO) |
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