Cerebral Palsy: Short-burst Interval Training

Cerebral Palsy Spastic Diplegia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03373890
• Other study ID #: R21HD077186
• Status: Completed
• Phase: N/A
• Start date: August 1, 2014
• Est. completion date: July 31, 2016

Study information

• Verified date: June 2019
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 31, 2016
• Est. primary completion date: July 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy Spastic Diplegia

Intervention

Behavioral:
• 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.,

Locations

Country	Name	City	State
United States	Seattle Children's Research Institute	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Children's Hospital	Louisiana State University Health Sciences Center in New Orleans

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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 from baseline to immediately post SBLTT
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 from baseline to immediately post SBLTT
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 from baseline to immediately post SBLT.
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 from baseline to immediately post SBLTT
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	Change from baseline to 6 weeks post SBLTT
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 from baseline to immediately post SBLTT
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 from baseline to immediately post SBLTT
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 from baseline to immediately post SBLTT