Vibration Therapy for Cerebral Palsy

N/A

Waitlist Available

Led By Christopher M Modlesky, PhD

Research Sponsored by University of Georgia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 month, 6 months, 7 months, and 12 months

Summary

This trial will study the effects of low-magnitude vibration on muscle, physical activity, and balance in children with spastic cerebral palsy.

Who is the study for?

This trial is for children with spastic cerebral palsy who can walk on their own without help. They shouldn't have had certain treatments like Botox in the past year, be taking specific bone medications, or have a Baclofen pump. Also, they must not have had recent leg surgery or fractures in both femurs or tibias.

What is being tested?

The study tests if standing on a vibration platform for six months can improve muscle condition, physical activity, and balance compared to a placebo platform. After the initial period, there's another six months where no treatment is given to see lasting effects.

What are the potential side effects?

Potential side effects are not detailed but may include discomfort from standing on the vibrating platform. Since it's non-invasive and doesn't involve drugs or surgery, serious side effects are unlikely.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 month, 6 months, 7 months, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 month, 6 months, 7 months, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 6 months, 7 months, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in fat concentration

Secondary study objectives

Change in dynamic balance

Change in muscle size

Change in physical activity

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Vibration PlatformExperimental Treatment1 Intervention

The vibration group will stand on a platform that emits a mild vibration 10 minutes per day for 6 months. There will also be a 6 month no-treatment period.

Group II: Placebo PlatformPlacebo Group1 Intervention

The placebo group will stand on a placebo platform 10 minutes per day for 6 months. There will also be a 6 month no-treatment period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vibration Platform

2009

Completed Phase 3

~150

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