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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
Able to stand with some support
Periventricular white matter injury from encephalopathy of prematurity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 6 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 can stand up if I have something to lean on.
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I have brain damage from premature birth complications.
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I have difficulty moving both of my legs.

Timeline

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

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
886 Previous Clinical Trials
384,718 Total Patients Enrolled
1 Trials studying Spastic Diplegia
4 Patients Enrolled for Spastic Diplegia
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,340 Previous Clinical Trials
26,452,638 Total Patients Enrolled
Jaynie Yang, PhdPrincipal InvestigatorUniverstiy of Alberta

Media Library

Intensive exercise Clinical Trial Eligibility Overview. Trial Name: NCT03672877 — N/A
Spastic Diplegia Research Study Groups: Immediate training group, Delay training group
Spastic Diplegia Clinical Trial 2023: Intensive exercise Highlights & Side Effects. Trial Name: NCT03672877 — N/A
Intensive exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT03672877 — N/A

Frequently Asked Questions

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

To whom is participation in this research open?

"Qualified candidates for this medical trial must have periventricular leukomalacia and be between 8 Months to 36 months of age. A total of 60 patients are being sought out for the experiment."

Answered by AI

Are geriatric individuals included in this research endeavor?

"This medical trial imposes an age limit of 36 months as the highest and 8 Months as the lowest for potential enrollees."

Answered by AI

How many participants are currently engaged in this investigation?

"Affirmative, according to the information stored on clinicaltrials.gov, this trial is recruiting patients now. Initially posted on January 28th 2019 and updated most recently on May 18th 2022, it seeks 60 participants at 2 sites."

Answered by AI

Could interested individuals join this investigation currently?

"Affirmative. The records present on clinicaltrials.gov show that this trial is presently accepting applicants and was initially posted on January 28th 2019. It needs 60 patients to be enrolled at two different medical centres."

Answered by AI
~10 spots leftby Apr 2025