Short-Burst Interval Treadmill Training Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Short Burst Interval Treadmill Training (SBLTT)
Traditional Locomotor Treadmill Training (TLTT)
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring treadmill training, gait, short burst interval locomotor training, spastic
Eligibility Criteria
Inclusion Criteria:
- Bilateral spastic cerebral palsy
- Gross Motor Function Classification Levels II & III
- Ages 6 years to < 11 years
Exclusion Criteria:
- Orthopedic or neurosurgery < 9 months prior
- Injection therapy (Botulinum Toxin/Phenol) < 3 months prior
Sites / Locations
- Lousianna State University Health Sciences Center New OrleansRecruiting
- Seattle Childrens Research InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Short burst Interval Treadmill Training (SBLTT)
Traditional Locomotor Treadmill Training (TLTT)
Arm Description
SBLTT will consist of short-bursts (30 seconds) of high speed walking alternating with 30 seconds of low/moderate speed walking. Participant will receive 40 home-based sessions (5x/week for 8 weeks) of SBLTT
TLTT will consist of walking at steady-state speeds. Participant will receive 40 home-based sessions (5x/week for 8 weeks) of TLTT
Outcomes
Primary Outcome Measures
Walking Capacity-Self-selected walking spee
10 Meter Walk Test
Walking Capacity-Fast walking speed
10 Meter Walk Test- fast speed
Walking Capacity-Endurance
One Minute Walk Test
Walking Performance-level
StepWatch (SW) accelerometry - average total steps per day
Walking Performance-Intensity
StepWatch (SW) accelerometry - average daily steps at low, medium and high step rates
Knee extensor muscle power
Isokinetic Average Power for Knee extensors at 60deg/s as measured by Biodex.
Secondary Outcome Measures
Walking Mobility -level home versus community
StepWatch (SW) synchronized with Global Positioning System (GPS) - average strides per day in home versus community
Walking Mobility-intensity home versus community
StepWatch (SW) synchronized with Global Positioning System (GPS) - average strides per day low, medium or high stride rate in home versus community
Mobility
Patient-Reported Outcomes Measurement Information System (PROMIS v1.0 Pediatric Profile) Mobility domain score
Family Gait Priorities and Quality of gait
Parent report Gait Outcome Assessment List (GOAL).total score
Knee extensor muscle torque
Isokinetic Peak Torque for knee extensors at 60 deg/s as measured by Biodex.
Full Information
NCT ID
NCT04026295
First Posted
July 17, 2019
Last Updated
May 18, 2022
Sponsor
Kristie Bjornson
Collaborators
University of Washington, Louisiana State University Health Sciences Center in New Orleans
1. Study Identification
Unique Protocol Identification Number
NCT04026295
Brief Title
Short-Burst Interval Treadmill Training Cerebral Palsy
Official Title
Short-Burst Interval Treadmill Training to Improve Community Walking Activity and Mobility in Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 27, 2019 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kristie Bjornson
Collaborators
University of Washington, 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
Yes
5. Study Description
Brief Summary
Ambulatory children with cerebral palsy (CP) walk predominately in low intensity stride rates with little variability, thus limiting their walking activity and ability to participate in daily life. In contrast, typically developing (TD) children engage in short bursts of intense walking activity interspersed with varying intervals of low intensity walking within daily life. In order to optimize motor learning, active participation, task-specific training and multiple repetitions or massed practice is required to learn new motor skills. Short bursts of vigorous intensity locomotor treadmill training (SBLTT) alternating with low/moderate intensity was specifically designed to mimic activity patterns of TD children in a massed practice format. Pilot data suggests that SBLTT is feasible and enhances walking capacity and performance in daily life for children with CP. This project will examine the effect of SBLTT versus an equivalent dosage of traditional locomotor treadmill training (TLTT) on the primary outcomes of walking capacity and performance in children with CP and whether the effects of SBLTT on walking capacity and performance are mediated by improvements in in muscle power generation. The scientific premise is that SBLTT, that approximates the walking intensity patterns of typically developing (TD) children through a home-based massed practice protocol, will be more effective than TLTT in improving walking capacity and performance. We hypothesize that SBLTT strategies for children with CP modeled on walking patterns of TD children, will be positively mediated by muscle power generation and subsequently improve walking capacity and community walking performance and mobility. Specific aims. Aim #1. Determine the immediate and retention effects of short-burst interval LTT (SBLTT) on walking capacity in ambulatory children with CP. Aim #2. Examine the effects of treatment on community-based walking activity performance and mobility. Aim #3. Explore whether the effects of SBLTT on walking capacity and performance are mediated by muscle power generation. The proposed research will be the first step in a continuum of research that is expected to direct locomotor training protocols and rehab strategies across pediatric disabilities and positively effecting the community walking performance and mobility for children with CP.
Detailed Description
In a randomized clinical trial, 72 ambulatory children with spastic CP (6-10 yrs.) will receive either SBLTT or an equivalent dosage of TLTT for 40 sessions, 5x/week for 8 weeks in a massed practice format. The only difference between training protocols will be the variable training (interval fast versus steady state walking speeds). Thus, the key ingredient will be the intensity of the interval training delivered in a serial blocked practice schedule. Outcomes will be collected at baseline, 4 and 8 weeks to assess dosage, and 24 weeks post training for long term retention with the primary endpoint at 8 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
treadmill training, gait, short burst interval locomotor training, spastic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomized to either short-burst interval locomotor treadmill training (SBLTT) or traditional locomotor treadmill training (TLTT)
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Short burst Interval Treadmill Training (SBLTT)
Arm Type
Experimental
Arm Description
SBLTT will consist of short-bursts (30 seconds) of high speed walking alternating with 30 seconds of low/moderate speed walking. Participant will receive 40 home-based sessions (5x/week for 8 weeks) of SBLTT
Arm Title
Traditional Locomotor Treadmill Training (TLTT)
Arm Type
Active Comparator
Arm Description
TLTT will consist of walking at steady-state speeds. Participant will receive 40 home-based sessions (5x/week for 8 weeks) of TLTT
Intervention Type
Behavioral
Intervention Name(s)
Short Burst Interval Treadmill Training (SBLTT)
Intervention Description
SBLTT will consist of short-bursts (30 seconds) of high speed walking alternating with 30 seconds of low/moderate speed walking. Total duration of walking per session will be up to 30 minutes of the 30 second alternating intervals (30sec high / 30sec low/moderate) with rests as needed. Both groups will receive 40 sessions delivered 5x/week for 8 weeks. Initial speeds for high speed walking will be 75-80% of each participant's over ground baseline fast walking speed, and low/moderate speed will be 75-80% of self-selected speed calculated from the 10-Meter Walk Test.
Intervention Type
Behavioral
Intervention Name(s)
Traditional Locomotor Treadmill Training (TLTT)
Intervention Description
TLTT group will receive the same number of sessions (40) delivered 5x/week for 8 weeks with a total duration of walking per session up to 30 minutes with rests as needed. TLTT will consist of walking at steady-state speeds. Initial treadmill speed will be 75-80% of over ground self-selected walking speed. The overall goal will be to achieve 30 minutes of walking at a steady-state walking speed within each session. Speed will be increased on the next session by .1 to .4mph when the subject can walk for 30 minutes on the treadmill at the current speed with an OMNI score of < 6/10.
Primary Outcome Measure Information:
Title
Walking Capacity-Self-selected walking spee
Description
10 Meter Walk Test
Time Frame
Baseline to 8 weeks
Title
Walking Capacity-Fast walking speed
Description
10 Meter Walk Test- fast speed
Time Frame
Baseline to 8 weeks
Title
Walking Capacity-Endurance
Description
One Minute Walk Test
Time Frame
Baseline to 8 weeks
Title
Walking Performance-level
Description
StepWatch (SW) accelerometry - average total steps per day
Time Frame
Baseline to 8 weeks
Title
Walking Performance-Intensity
Description
StepWatch (SW) accelerometry - average daily steps at low, medium and high step rates
Time Frame
Baseline to 8 weeks
Title
Knee extensor muscle power
Description
Isokinetic Average Power for Knee extensors at 60deg/s as measured by Biodex.
Time Frame
Baseline to 8 weeks.
Secondary Outcome Measure Information:
Title
Walking Mobility -level home versus community
Description
StepWatch (SW) synchronized with Global Positioning System (GPS) - average strides per day in home versus community
Time Frame
Baseline to 8 weeks
Title
Walking Mobility-intensity home versus community
Description
StepWatch (SW) synchronized with Global Positioning System (GPS) - average strides per day low, medium or high stride rate in home versus community
Time Frame
Baseline to 8 weeks
Title
Mobility
Description
Patient-Reported Outcomes Measurement Information System (PROMIS v1.0 Pediatric Profile) Mobility domain score
Time Frame
Baseline to 8 weeks
Title
Family Gait Priorities and Quality of gait
Description
Parent report Gait Outcome Assessment List (GOAL).total score
Time Frame
Baseline to 8 weeks
Title
Knee extensor muscle torque
Description
Isokinetic Peak Torque for knee extensors at 60 deg/s as measured by Biodex.
Time Frame
Baseline to 8 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Bilateral spastic cerebral palsy
Gross Motor Function Classification Levels II & III
Ages 6 years to < 11 years
Exclusion Criteria:
Orthopedic or neurosurgery < 9 months prior
Injection therapy (Botulinum Toxin/Phenol) < 3 months prior
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristie F Bjornson, PhD, PT
Phone
206-8842066
Email
kristie.bjornson@seattlechildrens.org
First Name & Middle Initial & Last Name or Official Title & Degree
Neil Panlasigui, BS
Phone
206-884-2066
Email
neil.panlasigui@seattlechildrens.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristie F Bjornson, PhD, PT
Organizational Affiliation
Seattle Children's Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Noelle Moreau, PhD, PT
Organizational Affiliation
Lousianna State University in New Orleans
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lousianna State University Health Sciences Center New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noelle Moreau, PhD, PT
Phone
504-568-4291
Email
NMorea@lsuhsc.edu
Facility Name
Seattle Childrens Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristie F Bjornson, PhD, PT
Phone
206-884-2066
Email
kristie.bjornson@seattlechildrens.org
First Name & Middle Initial & Last Name & Degree
Neil Panlasigui, BS
Phone
206-884-2066
Email
neil.panlasigui@seattlechildrens.org
12. IPD Sharing Statement
Plan to Share IPD
No
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Short-Burst Interval Treadmill Training Cerebral Palsy
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