Short-Burst Interval Treadmill Training Cerebral Palsy

NCT04026295 | Active Not Recruiting DMC

• 1 other identifier: R01HD098270
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Cerebral Palsy

Keywords

treadmill training; gait; short burst interval locomotor training; spastic

Outcome Measures

Primary Outcomes (6)

• Walking Capacity-Self-selected walking speed

  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 - percent of strides/day in medium/high stride 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 Outcomes (7)

• Walking Mobility -level home

  Baseline to 8 weeks

• Walking Mobility-intensity home

  Baseline to 8 weeks

• Mobility-Patient Reported Outcome

  Baseline to 8 weeks

• Family Gait Priorities and Quality of gait

  Baseline to 8 weeks

• Knee extensor muscle torque

  Baseline to 8 weeks.

Study Arms (2)

Short burst Interval Treadmill Training (SBLTT)

EXPERIMENTAL

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)

Traditional Locomotor Treadmill Training (TLTT)

ACTIVE COMPARATOR

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)

Interventions

Short Burst Interval Treadmill Training (SBLTT) BEHAVIORAL

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.

Short burst Interval Treadmill Training (SBLTT)

Traditional Locomotor Treadmill Training (TLTT) BEHAVIORAL

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.

Traditional Locomotor Treadmill Training (TLTT)

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Bilateral and unilateral spastic cerebral palsy
• Gross Motor Function Classification Levels II \& III
• Ages 6 years to \< 11 years

You may not qualify if:

• Orthopedic or neurosurgery \< 9 months prior
• Injection therapy (Botulinum Toxin/Phenol) \< 3 months prior

Sponsors & Collaborators

• Kristie Bjornson: lead
• University of Washington: collaborator
• Louisiana State University Health Sciences Center in New Orleans: collaborator

Study Sites (2)

Lousianna State University Health Sciences Center New Orleans

New Orleans, Louisiana, 70112, United States

Location

Seattle Childrens Research Institute

Seattle, Washington, 98121, United States

Location

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kristie F Bjornson, PhD, PT

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

• Noelle Moreau, PhD, PT

  Lousianna State University in New Orleans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Pediatrics

Model Details: Participants are randomized to either short-burst interval locomotor treadmill training (SBLTT) or traditional locomotor treadmill training (TLTT)

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 19, 2019
• Study Start: November 27, 2019
• Primary Completion: June 1, 2025
• Study Completion: August 31, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)