Cerebral Palsy: Short-burst Interval Training

• ClinicalTrials.gov Identifier: NCT03373890
• Recruitment Status: Completed
• First Posted: December 14, 2017
• Results First Posted: July 10, 2019
• Last Update Posted: July 10, 2019
• Sponsor: Seattle Children's Hospital
• Collaborator: Louisiana State University Health Sciences Center in New Orleans
• Information provided by (Responsible Party): Kristie Bjornson, Seattle Children's Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cerebral Palsy Spastic Diplegia	Behavioral: Short Burst Interval Locomotor Treadmill Training (SBLTT)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Pre/post intervention design with participants randomized to two different frequency of intervention
• Masking: Single (Outcomes Assessor)
• Masking Description: Muscle function assessor masked to frequency group, Muscle architecture captured via ultrasound Community walking activity collected by accelerometry, thus non-human data collection
• Primary Purpose: Treatment
• Official Title: Muscle Performance and Walking in Cerebral Palsy: Short-burst Interval Training
• Actual Study Start Date: August 1, 2014
• Actual Primary Completion Date: July 31, 2016
• Actual Study Completion Date: July 31, 2016

Arms and Interventions

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.,

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 5 Years to 12 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Washington

Seattle Children's Research Institute

Seattle, Washington, United States, 98115

Sponsors and Collaborators

Seattle Children's Hospital

Louisiana State University Health Sciences Center in New Orleans

Investigators

• Study Director: James Hendricks, PhD; Seattle Children's Research Institute

More Information

• Responsible Party: Kristie Bjornson, Associate Professor, Pediatrics, Seattle Children's Hospital
• ClinicalTrials.gov Identifier: NCT03373890
• Other Study ID Numbers: R21HD077186 ( U.S. NIH Grant/Contract )
• First Posted: December 14, 2017
• Results First Posted: July 10, 2019
• Last Update Posted: July 10, 2019
• Last Verified: June 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Cerebral Palsy; Nervous System Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases