Cerebral Palsy: Short-burst Interval Training

Muscle Performance and Walking in 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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy Spastic Diplegia
• Intervention / Treatment: Behavioral: Short Burst Interval Locomotor Treadmill Training (SBLTT)

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98115
      • Seattle Children's Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Short burst Interval Treadmill Training High Frequency; 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); 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.,
ACTIVE_COMPARATOR: Short Burst Interval Treadmill Training Low Frequency; 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); 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.,

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Collaborators: Louisiana State University Health Sciences Center in New Orleans
• Investigators: Study Director: James Hendricks, PhD, Seattle Children's Research Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2014
• Primary Completion (ACTUAL): July 31, 2016
• Study Completion (ACTUAL): July 31, 2016

Study Registration Dates

• First Submitted: December 6, 2017
• First Submitted That Met QC Criteria: December 11, 2017
• First Posted (ACTUAL): December 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 10, 2019
• Last Update Submitted That Met QC Criteria: June 20, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: R21HD077186 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No