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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

Must not have

Injection therapy (Botulinum Toxin/Phenol) < 3 months prior

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 8 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had injection therapy like Botox or Phenol in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 8 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Knee extensor muscle power

Walking Capacity-Endurance

Walking Capacity-Fast walking speed

+3 more

Secondary study objectives

Family Gait Priorities and Quality of gait

Knee extensor muscle torque

Mobility

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 4Eligibility criteria met