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Cerebral Palsy: Short-burst Interval Training

Primary Purpose

Cerebral Palsy Spastic Diplegia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Short Burst Interval Locomotor Treadmill Training (SBLTT)
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy Spastic Diplegia

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seattle Children's Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Short burst Interval Treadmill Training High Frequency

Short Burst Interval Treadmill Training Low Frequency

Arm Description

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

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

Outcomes

Primary Outcome Measures

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 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 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 in Walking Endurance- High Versus Low Frequency SBLTT Groups
Distance walked during the One Minute Walk Test High Versus Low Frequency SBLTT Groups

Secondary Outcome Measures

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 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 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 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

Full Information

First Posted
December 6, 2017
Last Updated
June 20, 2019
Sponsor
Seattle Children's Hospital
Collaborators
Louisiana State University Health Sciences Center in New Orleans
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1. Study Identification

Unique Protocol Identification Number
NCT03373890
Brief Title
Cerebral Palsy: Short-burst Interval Training
Official Title
Muscle Performance and Walking in Cerebral Palsy: Short-burst Interval Training
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2014 (Actual)
Primary Completion Date
July 31, 2016 (Actual)
Study Completion Date
July 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital
Collaborators
Louisiana State University Health Sciences Center in New Orleans

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy Spastic Diplegia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pre/post intervention design with participants randomized to two different frequency of intervention
Masking
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
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Short burst Interval Treadmill Training High Frequency
Arm Type
Experimental
Arm Description
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
Arm Title
Short Burst Interval Treadmill Training Low Frequency
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Short Burst Interval Locomotor Treadmill Training (SBLTT)
Intervention Description
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 Outcome Measure Information:
Title
Change in Walking Performance High Versus Low Frequency SBLTT Groups
Description
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
Time Frame
Change from baseline to immediately post SBLTT
Title
Change in Community Walking Performance Intensity High Versus Low Frequency SBLTT Groups
Description
Average Strides/day > 30 strides/min as measured by StepWatch accelerometry High Versus Low Frequency SBLTT Groups
Time Frame
Change from baseline to immediately post SBLTT
Title
Change in Walking Capacity High Versus Low Frequency SBLTT Groups
Description
Self selected walking speed as measured by 10 meter walk test High Versus Low Frequency SBLTT Groups
Time Frame
Change from baseline to immediately post SBLT.
Title
Change in Walking Endurance- High Versus Low Frequency SBLTT Groups
Description
Distance walked during the One Minute Walk Test High Versus Low Frequency SBLTT Groups
Time Frame
Change from baseline to immediately post SBLTT
Secondary Outcome Measure Information:
Title
Change in Muscle Performance -Power High Versus Low Frequency SBLTT Groups
Description
Knee extensor muscle power - isotonic muscle power as measured by Biodex testing High Versus Low Frequency SBLTT Groups
Time Frame
Change from baseline to 6 weeks post SBLTT
Title
Change in Muscle Performance - Strength High Versus Low Frequency SBLTT Groups
Description
Knee extensor muscle strength - isometric muscle strength as measured by Biodex testing High Versus Low Frequency SBLTT Groups
Time Frame
Change from baseline to immediately post SBLTT
Title
Change in Muscle Architecture-High Versus Low Frequency SBLTT Groups
Description
Rectus femoris mid thigh cross-sectional area as measured by 2D B Mode Ultrasound High Versus Low Frequency SBLTT Groups
Time Frame
Change from baseline to immediately post SBLTT
Title
Change in Muscle Architecture-hypertrophy High Versus Low Frequency SBLTT Groups
Description
Rectus femoris mid thigh fascicle length as measured by 2D B Mode Ultrasound High Versus Low Frequency SBLTT Groups
Time Frame
Change from baseline to immediately post SBLTT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Hendricks, PhD
Organizational Affiliation
Seattle Children's Research Institute
Official's Role
Study Director
Facility Information:
Facility Name
Seattle Children's Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Cerebral Palsy: Short-burst Interval Training

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