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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
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 belowSelect...
I have brain damage from premature birth complications.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have received BTX-A injections in my legs within the last 6 months.
Select...
I have significant difficulty using my hands and arms for daily tasks.
Select...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Gross Motor Functional Measure - 66 Items (GMFM-66)
Secondary outcome measures
Change in stiffness at the ankle
Change on Pediatric Quality of Life Measure module for cerebral palsy (PedsQL CP)
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
Find a Location
Who is running the clinical trial?
University of AlbertaLead Sponsor
901 Previous Clinical Trials
387,490 Total Patients Enrolled
1 Trials studying Spastic Diplegia
4 Patients Enrolled for Spastic Diplegia
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,354 Previous Clinical Trials
26,460,459 Total Patients Enrolled
Jaynie Yang, PhdPrincipal InvestigatorUniverstiy of Alberta
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received BTX-A injections in my legs within the last 6 months.I have heart or muscle issues that prevent me from doing intense exercise.I can stand up if I have something to lean on.I have brain damage from premature birth complications.I have significant difficulty using my hands and arms for daily tasks.I have difficulty moving both of my legs.I have not had uncontrolled seizures or infantile spasms in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Immediate training group
- Group 2: Delay training group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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