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Interval Treadmill Training for Cerebral Palsy

N/A
Recruiting
Led By Kristie F Bjornson, PhD, PT
Research Sponsored by Kristie Bjornson
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Gross Motor Function Classification Levels II & III
Bilateral spastic cerebral palsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 8 weeks
Awards & highlights

Study Summary

This trial will compare the effects of two different types of locomotor training on ambulatory children with cerebral palsy. The first group will do short bursts of intense walking with low/moderate intensity in between. The second group will do traditional locomotor training at a constant low/moderate intensity. The goal is to see if the first group's walking capacity and performance improves more than the second group's, and whether this effect is mediated by improvements in muscle power generation.

Who is the study for?
This trial is for children aged 6 to less than 11 years with bilateral spastic cerebral palsy at certain levels of motor function (Levels II & III). They shouldn't have had orthopedic or neurosurgery in the last 9 months or injection therapies like Botox in the last 3 months.Check my eligibility
What is being tested?
The study compares two types of treadmill training: Short Burst Interval Treadmill Training (SBLTT) and Traditional Locomotor Treadmill Training (TLTT). It aims to see if SBLTT, which mimics typical walking patterns, improves walking capacity and daily mobility more effectively than TLTT.See study design
What are the potential side effects?
While specific side effects are not listed, exercise-based interventions like these may cause muscle fatigue, soreness, or increase the risk of falls during training sessions. Close supervision is expected to minimize risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My mobility is moderately affected.
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I have bilateral spastic cerebral palsy.
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I am between 6 and 10 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Knee extensor muscle power
Walking Capacity-Endurance
Walking Capacity-Fast walking speed
+3 more
Secondary outcome measures
Family Gait Priorities and Quality of gait
Knee extensor muscle torque
Mobility
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Short burst Interval Treadmill Training (SBLTT)Experimental Treatment1 Intervention
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 II: Traditional Locomotor Treadmill Training (TLTT)Active Control1 Intervention
TLTT will consist of walking at steady-state speeds. Participant will receive 40 home-based sessions (5x/week for 8 weeks) of TLTT

Find a Location

Who is running the clinical trial?

Louisiana State University Health Sciences Center in New OrleansOTHER
114 Previous Clinical Trials
44,129 Total Patients Enrolled
2 Trials studying Cerebral Palsy
55 Patients Enrolled for Cerebral Palsy
Kristie BjornsonLead Sponsor
University of WashingtonOTHER
1,741 Previous Clinical Trials
1,847,694 Total Patients Enrolled
10 Trials studying Cerebral Palsy
1,132 Patients Enrolled for Cerebral Palsy

Media Library

Short Burst Interval Treadmill Training (SBLTT) Clinical Trial Eligibility Overview. Trial Name: NCT04026295 — N/A
Cerebral Palsy Research Study Groups: Traditional Locomotor Treadmill Training (TLTT), Short burst Interval Treadmill Training (SBLTT)
Cerebral Palsy Clinical Trial 2023: Short Burst Interval Treadmill Training (SBLTT) Highlights & Side Effects. Trial Name: NCT04026295 — N/A
Short Burst Interval Treadmill Training (SBLTT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04026295 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What eligibility criteria is necessary to participate in this experiment?

"The study is currently searching for 72 children, aged between 6 and 10 years old, that have been diagnosed with cerebral palsy. To be eligible to participate in the trial a patient must meet all of these criteria: bilateral spastic cerebral palsy, gross motor function classification levels II & III within the age range of 6-11."

Answered by AI

Are participants of at least twenty years in age eligible to join this clinical trial?

"This medical trial has age limitations for potential participants. The lower limit is 6 years old, whereas the upper bound of eligibility caps at 10 years old."

Answered by AI

How many participants have been enrolled in this research study?

"Affirmative. The information on clinicaltrials.gov confirms that the trial, initially posted in late November 2019, is now seeking participants from two medical centres with a total of 72 people required for enrolment."

Answered by AI

What are the primary goals of this research endeavor?

"The primary evaluation metric for this trial spans from the baseline to 8 weeks and involves assessing participant's walking capacity at self-selected speeds. Secondary measures include Mobility, recorded via PROMIS v1.0 Pediatric Profile scores; Walking Mobility in home versus community environments tracked by StepWatch (SW) with Global Positioning System support; as well as Family Gait Priorities and Quality of gait scored using Parent report Gait Outcome Assessment List total score."

Answered by AI

Are there any opportunities for prospective participants to join this experiment?

"Affirmative. Clinicaltrials.gov displays that this clinical trial, originally posted on November 27th 2019, is actively seeking participants. The study necessitates the recruitment of 72 individuals from 2 distinct medical facilities."

Answered by AI
~14 spots leftby Jun 2025