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NCT Number: NCT04026295

Short-Burst Interval Treadmill Training 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lousianna State University Health Sciences Center New Orleans, New Orleans, Louisiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Bilateral and unilateral 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Walking Capacity-Self-selected walking speed

    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 - percent of strides/day in medium/high stride 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 outcomes

  1. Walking Mobility -level home

    Time frame: Baseline to 8 weeks

    StepWatch (SW) synchronized with Global Positioning System (GPS) home setting- average strides per day.

  2. Walking Mobility-intensity home

    Time frame: Baseline to 8 weeks

    StepWatch (SW) synchronized with Global Positioning System (GPS) home setting- percent average strides/day in medium/high stride rates.

  3. Mobility-Patient Reported Outcome

    Time frame: Baseline to 8 weeks

    Patient-Reported Outcomes Measurement Information System (PROMIS v1.0 Parent 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.

  6. Walking Mobility-intensity community

    Time frame: Baseline to 8 weeks

    StepWatch (SW) synchronized with Global Positioning System (GPS) community setting- percent average strides/day in medium/high stride rates.

  7. Walking Mobility -level community

    Time frame: Baseline to 8 weeks

    StepWatch (SW) synchronized with Global Positioning System (GPS) community setting- average strides/day.

Sponsors and collaborators

Lead sponsor

Kristie Bjornson

Other

Collaborators

  • Louisiana State University Health Sciences Center in New Orleans
  • University of Washington

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jul 19, 2019
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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