Clinical trial NCT03373890: Cerebral Palsy: Short-burst Interval Training
Official title: Muscle Performance and Walking in Cerebral Palsy: Short-burst Interval Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy Spastic Diplegia
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: Louisiana State University Health Sciences Center in New Orleans
First posted: 2017-12-14
Enrollment: 12
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pre/post intervention design with participants randomized to two different frequency of intervention
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Walking Performance High Versus Low Frequency SBLTT Groups
timeFrame: Change from baseline to immediately post SBLTT
measure: Change in Community Walking Performance Intensity High Versus Low Frequency SBLTT Groups
timeFrame: Change from baseline to immediately post SBLTT
measure: Change in Walking Capacity High Versus Low Frequency SBLTT Groups
timeFrame: Change from baseline to immediately post SBLT.
measure: Change in Walking Endurance- High Versus Low Frequency SBLTT Groups
timeFrame: Change from baseline to immediately post SBLTT
Secondary outcomes:
measure: Change in Muscle Performance -Power High Versus Low Frequency SBLTT Groups
timeFrame: Change from baseline to 6 weeks post SBLTT
measure: Change in Muscle Performance - Strength High Versus Low Frequency SBLTT Groups
timeFrame: Change from baseline to immediately post SBLTT
measure: Change in Muscle Architecture-High Versus Low Frequency SBLTT Groups
timeFrame: Change from baseline to immediately post SBLTT
measure: Change in Muscle Architecture-hypertrophy High Versus Low Frequency SBLTT Groups
timeFrame: Change from baseline to immediately post SBLTT
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Research Institute
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: James Hendricks, PhD
role: STUDY_DIRECTOR
References: