Short-Burst Interval Treadmill Training Cerebral Palsy

Short-Burst Interval Treadmill Training to Improve Community Walking Activity and Mobility in Cerebral Palsy

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Behavioral: Short Burst Interval Treadmill Training (SBLTT); Behavioral: Traditional Locomotor Treadmill Training (TLTT)

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.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristie F Bjornson, PhD, PT; Phone Number: 206-8842066; Email: kristie.bjornson@seattlechildrens.org
• Study Contact Backup: Name: Neil Panlasigui, BS; Phone Number: 206-884-2066; Email: neil.panlasigui@seattlechildrens.org

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Recruiting
      • Lousianna State University Health Sciences Center New Orleans
      • Contact: Noelle Moreau, PhD, PT; Phone Number: 504-568-4291; Email: NMorea@lsuhsc.edu
  • Washington
    • Seattle, Washington, United States, 98121
      • Recruiting
      • Seattle Childrens Research Institute
      • Contact: Neil Panlasigui, BS; Phone Number: 206-884-2066; Email: neil.panlasigui@seattlechildrens.org
      • Contact: Kristie F Bjornson, PhD, PT; Phone Number: 206-884-2066; Email: kristie.bjornson@seattlechildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking Capacity-Self-selected walking spee	10 Meter Walk Test	Baseline to 8 weeks
Walking Capacity-Fast walking speed	10 Meter Walk Test- fast speed	Baseline to 8 weeks
Walking Capacity-Endurance	One Minute Walk Test	Baseline to 8 weeks
Walking Performance-level	StepWatch (SW) accelerometry - average total steps per day	Baseline to 8 weeks
Walking Performance-Intensity	StepWatch (SW) accelerometry - average daily steps at low, medium and high step rates	Baseline to 8 weeks
Knee extensor muscle power	Isokinetic Average Power for Knee extensors at 60deg/s as measured by Biodex.	Baseline to 8 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking Mobility -level home versus community	StepWatch (SW) synchronized with Global Positioning System (GPS) - average strides per day in home versus community	Baseline to 8 weeks
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	Baseline to 8 weeks
Mobility	Patient-Reported Outcomes Measurement Information System (PROMIS v1.0 Pediatric Profile) Mobility domain score	Baseline to 8 weeks
Family Gait Priorities and Quality of gait	Parent report Gait Outcome Assessment List (GOAL).total score	Baseline to 8 weeks
Knee extensor muscle torque	Isokinetic Peak Torque for knee extensors at 60 deg/s as measured by Biodex.	Baseline to 8 weeks.

Collaborators and Investigators

• Sponsor: Kristie Bjornson
• Collaborators: University of Washington; Louisiana State University Health Sciences Center in New Orleans
• Investigators: Principal Investigator: Kristie F Bjornson, PhD, PT, Seattle Children's Research Institute; Principal Investigator: Noelle Moreau, PhD, PT, Lousianna State University in New Orleans

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2019
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: July 17, 2019
• First Submitted That Met QC Criteria: July 17, 2019
• First Posted (Actual): July 19, 2019

Study Record Updates

• Last Update Posted (Actual): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: gait; treadmill training; short burst interval locomotor training; spastic
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: R01HD098270 (U.S. NIH Grant/Contract)

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