Cerebral Palsy: Short-burst Interval Training

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Muscle Performance and Walking in Cerebral Palsy: Short-burst Interval Training

Conditions
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Cerebral Palsy Spastic Diplegia

Intervention / Treatment
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* Behavioral: Short Burst Interval Locomotor Treadmill Training (SBLTT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ambulatory children with cerebral palsy Spasticity primary movement disorder Bilateral motor impairment (Diplegia) Gross Motor Function Classification System Levels II and III Exclusion Criteria: undergone orthopedic or neurosurgery less than 12 months prior injection therapies (phenol, botulinum toxin) less than 3 months prior

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pre/post intervention design with participants randomized to two different frequency of intervention
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short burst Interval Treadmill Training High Frequency<br>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 | Behavioral: Short Burst Interval Locomotor Treadmill Training (SBLTT)<br>* 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.,<br>|
| Active Comparator: Short Burst Interval Treadmill Training Low Frequency<br>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 | Behavioral: Short Burst Interval Locomotor Treadmill Training (SBLTT)<br>* 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.,<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |