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Short-Burst Interval Treadmill Training Cerebral Palsy

K

Kristie Bjornson

Status

Enrolling

Conditions

Cerebral Palsy

Treatments

Behavioral: Traditional Locomotor Treadmill Training (TLTT)
Behavioral: Short Burst Interval Treadmill Training (SBLTT)

Study type

Interventional

Funder types

Other

Identifiers

NCT04026295
R01HD098270

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 estimated patients

Sex

All

Ages

6 to 10 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

72 participants in 2 patient groups

Short burst Interval Treadmill Training (SBLTT)
Experimental group
Description:
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
Treatment:
Behavioral: Short Burst Interval Treadmill Training (SBLTT)
Traditional Locomotor Treadmill Training (TLTT)
Active Comparator group
Description:
TLTT will consist of walking at steady-state speeds. Participant will receive 40 home-based sessions (5x/week for 8 weeks) of TLTT
Treatment:
Behavioral: Traditional Locomotor Treadmill Training (TLTT)

Trial contacts and locations

2

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Central trial contact

Kristie F Bjornson, PhD, PT; Neil Panlasigui, BS

Data sourced from clinicaltrials.gov

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