Short-Burst Interval Treadmill Training Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04026295
• Other study ID #: R01HD098270
• Status: Recruiting
• Phase: N/A
• Start date: November 27, 2019
• Est. completion date: May 31, 2026

Study information

• Verified date: April 2024
• Source: Seattle Children's Hospital
• Contact: Kristie F Bjornson, PhD, PT
• Phone: 206-8842066
• Email: kristie.bjornson[@]seattlechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: May 31, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Lousianna State University Health Sciences Center New Orleans	New Orleans	Louisiana
United States	Seattle Childrens Research Institute	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Kristie Bjornson	Louisiana State University Health Sciences Center in New Orleans, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walking Capacity-Self-selected walking spee	10 Meter Walk Test	Baseline to 8 weeks
Primary	Walking Capacity-Fast walking speed	10 Meter Walk Test- fast speed	Baseline to 8 weeks
Primary	Walking Capacity-Endurance	One Minute Walk Test	Baseline to 8 weeks
Primary	Walking Performance-level	StepWatch (SW) accelerometry - average total steps per day	Baseline to 8 weeks
Primary	Walking Performance-Intensity	StepWatch (SW) accelerometry - average daily steps at low, medium and high step rates	Baseline to 8 weeks
Primary	Knee extensor muscle power	Isokinetic Average Power for Knee extensors at 60deg/s as measured by Biodex.	Baseline to 8 weeks.
Secondary	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
Secondary	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
Secondary	Mobility	Patient-Reported Outcomes Measurement Information System (PROMIS v1.0 Pediatric Profile) Mobility domain score	Baseline to 8 weeks
Secondary	Family Gait Priorities and Quality of gait	Parent report Gait Outcome Assessment List (GOAL).total score	Baseline to 8 weeks
Secondary	Knee extensor muscle torque	Isokinetic Peak Torque for knee extensors at 60 deg/s as measured by Biodex.	Baseline to 8 weeks.