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Short-Burst Interval Treadmill Training Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT04026295
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : January 9, 2020
Sponsor:
Collaborator:
Louisiana State University Health Sciences Center in New Orleans
Information provided by (Responsible Party):
Kristie Bjornson, Seattle Children's Hospital

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are randomized to either short-burst interval locomotor treadmill training (SBLTT) or traditional locomotor treadmill training (TLTT)
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Short-Burst Interval Treadmill Training to Improve Community Walking Activity and Mobility in Cerebral Palsy
Actual Study Start Date : November 27, 2019
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Short burst Interval Treadmill Training (SBLTT)
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
Behavioral: Short Burst Interval Treadmill Training (SBLTT)
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.

Active Comparator: Traditional Locomotor Treadmill Training (TLTT)
TLTT will consist of walking at steady-state speeds. Participant will receive 40 home-based sessions (5x/week for 8 weeks) of TLTT
Behavioral: Traditional Locomotor Treadmill Training (TLTT)
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 Measures :
  1. Walking Capacity-Self-selected walking spee [ Time Frame: Baseline to 8 weeks ]
    10 Meter Walk Test

  2. Walking Capacity-Fast walking speed [ Time Frame: Baseline to 8 weeks ]
    10 Meter Walk Test- fast speed

  3. Walking Capacity-Endurance [ Time Frame: Baseline to 8 weeks ]
    One Minute Walk Test

  4. Walking Performance-level [ Time Frame: Baseline to 8 weeks ]
    StepWatch (SW) accelerometry - average total steps per day

  5. Walking Performance-Intensity [ Time Frame: Baseline to 8 weeks ]
    StepWatch (SW) accelerometry - average daily steps at low, medium and high step rates

  6. Knee extensor muscle power [ Time Frame: Baseline to 8 weeks. ]
    Isokinetic Average Power for Knee extensors at 60deg/s as measured by Biodex.


Secondary Outcome Measures :
  1. Walking Mobility -level home versus community [ Time Frame: Baseline to 8 weeks ]
    StepWatch (SW) synchronized with Global Positioning System (GPS) - average strides per day in home versus community

  2. Walking Mobility-intensity home versus community [ Time Frame: Baseline to 8 weeks ]
    StepWatch (SW) synchronized with Global Positioning System (GPS) - average strides per day low, medium or high stride rate in home versus community

  3. Mobility [ Time Frame: Baseline to 8 weeks ]
    Patient-Reported Outcomes Measurement Information System (PROMIS v1.0 Pediatric Profile) Mobility domain score

  4. Family Gait Priorities and Quality of gait [ Time Frame: Baseline to 8 weeks ]
    Parent report Gait Outcome Assessment List (GOAL).total score

  5. Knee extensor muscle torque [ Time Frame: Baseline to 8 weeks. ]
    Isokinetic Peak Torque for knee extensors at 60 deg/s as measured by Biodex.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04026295


Contacts
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Contact: Kristie F Bjornson, PhD, PT 206-8842066 kristie.bjornson@seattlechildrens.org
Contact: Neil Panlasigui, BS 206-884-2066 neil.panlasigui@seattlechildrens.org

Locations
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United States, Louisiana
Lousianna State University Health Sciences Center New Orleans Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Noelle Moreau, PhD, PT    504-568-4291    NMorea@lsuhsc.edu   
United States, Washington
Seattle Childrens Research Institute Recruiting
Seattle, Washington, United States, 98121
Contact: Kristie F Bjornson, PhD, PT    206-884-2066    kristie.bjornson@seattlechildrens.org   
Contact: Neil Panlasigui, BS    206-884-2066    neil.panlasigui@seattlechildrens.org   
Sponsors and Collaborators
Seattle Children's Hospital
Louisiana State University Health Sciences Center in New Orleans
Investigators
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Principal Investigator: Kristie F Bjornson, PhD, PT Seattle Children's Research Institute
Principal Investigator: Noelle Moreau, PhD, PT Lousianna State University in New Orleans

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Responsible Party: Kristie Bjornson, Associate Professor, Pediatrics, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT04026295    
Other Study ID Numbers: R01HD098270 ( U.S. NIH Grant/Contract )
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kristie Bjornson, Seattle Children's Hospital:
treadmill training
gait
short burst interval locomotor training
spastic
Additional relevant MeSH terms:
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Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases