Short-Burst Interval Treadmill Training Cerebral Palsy

NCT ID: NCT04026295

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-27
• Study Completion Date: 2025-08-31

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Short Burst Interval Treadmill Training (SBLTT)

Intervention Type: 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)

TLTT will consist of walking at steady-state speeds. Participant will receive 40 home-based sessions (5x/week for 8 weeks) of TLTT

Group Type: ACTIVE_COMPARATOR

Traditional Locomotor Treadmill Training (TLTT)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: collaborator

Louisiana State University Health Sciences Center in New Orleans

OTHER

Sponsor Role: collaborator

Kristie Bjornson

OTHER

Sponsor Role: lead

Responsible Party

Kristie Bjornson

Professor, Pediatrics

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kristie F Bjornson, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Noelle Moreau, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Lousianna State University in New Orleans

Locations

Lousianna State University Health Sciences Center New Orleans

New Orleans, Louisiana, United States

Seattle Childrens Research Institute

Seattle, Washington, United States

Countries

United States

Other Identifiers

R01HD098270

Identifier Type: NIH

Identifier Source: org_study_id

View Link