Short-Burst Interval Treadmill Training Cerebral Palsy

Not Applicable

Active, not recruiting

• Conditions: Cerebral Palsy

• Registration Number: NCT04026295
• Lead Sponsor: Kristie Bjornson

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.

Study Timeline

• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-07-17
• Study First Posted: 2019-07-19
• Study Start: 2019-11-27
• Primary Completion: 2025-06-01
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-25
• Last Update Posted: 2025-07-30
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Walking Capacity-Self-selected walking speed	Baseline to 8 weeks	10 Meter Walk Test
Walking Capacity-Fast walking speed	Baseline to 8 weeks	10 Meter Walk Test- fast speed
Walking Capacity-Endurance	Baseline to 8 weeks	One Minute Walk Test
Walking Performance-level	Baseline to 8 weeks	StepWatch (SW) accelerometry - average total steps per day
Walking Performance-Intensity	Baseline to 8 weeks	StepWatch (SW) accelerometry - percent of strides/day in medium/high stride rates.
Knee extensor muscle power	Baseline to 8 weeks.	Isokinetic Average Power for Knee extensors at 60deg/s as measured by Biodex.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

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

Seattle Childrens Research Institute; 🇺🇸 Seattle, Washington, United States