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Completed

NCT Number: NCT03373890

Cerebral Palsy: Short-burst Interval Training

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.

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Key information

Conditions

Cerebral Palsy Spastic Diplegia Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seattle Children's Research Institute

Seattle, Washington, 98115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.,

Primary outcomes

  1. Change in Walking Performance High Versus Low Frequency SBLTT Groups

    Time frame: Change from baseline to immediately post SBLTT

    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

  2. Change in Community Walking Performance Intensity High Versus Low Frequency SBLTT Groups

    Time frame: Change from baseline to immediately post SBLTT

    Average Strides/day > 30 strides/min as measured by StepWatch accelerometry High Versus Low Frequency SBLTT Groups

  3. Change in Walking Capacity High Versus Low Frequency SBLTT Groups

    Time frame: Change from baseline to immediately post SBLT.

    Self selected walking speed as measured by 10 meter walk test High Versus Low Frequency SBLTT Groups

  4. Change in Walking Endurance- High Versus Low Frequency SBLTT Groups

    Time frame: Change from baseline to immediately post SBLTT

    Distance walked during the One Minute Walk Test High Versus Low Frequency SBLTT Groups

Secondary outcomes

  1. Change in Muscle Performance -Power High Versus Low Frequency SBLTT Groups

    Time frame: Change from baseline to 6 weeks post SBLTT

    Knee extensor muscle power - isotonic muscle power as measured by Biodex testing High Versus Low Frequency SBLTT Groups

  2. Change in Muscle Performance - Strength High Versus Low Frequency SBLTT Groups

    Time frame: Change from baseline to immediately post SBLTT

    Knee extensor muscle strength - isometric muscle strength as measured by Biodex testing High Versus Low Frequency SBLTT Groups

  3. Change in Muscle Architecture-High Versus Low Frequency SBLTT Groups

    Time frame: Change from baseline to immediately post SBLTT

    Rectus femoris mid thigh cross-sectional area as measured by 2D B Mode Ultrasound High Versus Low Frequency SBLTT Groups

  4. Change in Muscle Architecture-hypertrophy High Versus Low Frequency SBLTT Groups

    Time frame: Change from baseline to immediately post SBLTT

    Rectus femoris mid thigh fascicle length as measured by 2D B Mode Ultrasound High Versus Low Frequency SBLTT Groups

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Collaborators

  • Louisiana State University Health Sciences Center in New Orleans

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 14, 2017
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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