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Intensive Leg Exercise for Spastic Diplegia

N/A

Recruiting

Led By Jaynie Yang, Phd

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

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

Must have

Periventricular white matter injury from encephalopathy of prematurity

Be younger than 18 years old

Must not have

Botulinum toxin-A (BTX-A) injections in the legs in the last 6 months

Substantial upper extremity involvement - Manual Abilities Classification System (MACS) Level ≥3

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two methods of physical therapy for improving leg movement in young children with a type of muscular paralysis.

Who is the study for?

This trial is for young children with spastic diplegia, a form of cerebral palsy affecting the legs. Participants must have bilateral motor impairment and be able to stand with support but not have severe upper limb involvement, recent leg injections (BTX-A), uncontrolled epilepsy, or conditions that make intensive exercise unsafe.

What is being tested?

The study tests whether 3 months of early intensive leg exercises can improve walking better than standard physiotherapy in children with spastic diplegia resulting from periventricular leukomalacia.

What are the potential side effects?

While specific side effects are not listed, intensive exercise may lead to muscle soreness, fatigue, and potential strain on muscles and joints in these young participants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have brain damage from premature birth complications.

Exclusion Criteria

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

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I have received BTX-A injections in my legs within the last 6 months.

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I have significant difficulty using my hands and arms for daily tasks.

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I have not had uncontrolled seizures or infantile spasms in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 6 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 Gross Motor Functional Measure - 66 Items (GMFM-66)

Secondary study objectives

Change in stiffness at the ankle

Change on Pediatric Quality of Life Measure module for cerebral palsy (PedsQL CP)

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: Immediate training groupExperimental Treatment1 Intervention

Children will participate in intensive exercise intervention for 3 months and will be followed for 9 months following the intervention

Group II: Delay training groupActive Control1 Intervention

Children will be assessed for 6 months with no intervention. After the 6 month period children will be given the same intervention as the immediate group and followed for 3 months after the intervention.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intensive exercise

2011

Completed Phase 4

~450

0 / 4Eligibility criteria met