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Intensive Exercise for Perinatal Stroke

N/A

Recruiting

Led By Jaynie Yang

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

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

Must have

Medical history and physical exam consistent with perinatal stroke

Hemiparesis in the upper and/or lower extremity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months, 6 months, 9 months, 12 months

Awards & highlights

Study Summary

This trial will compare the effects of intense physical therapy to usual care in order to see if early intervention can improve gross motor function.

Who is the study for?

This trial is for children aged 8 months to 3 years who have had a perinatal stroke, leading to weakness in the arms and/or legs. Parents must commit to the training schedule and be able to communicate in English or French. Children with seizures affecting training, bilateral motor issues, recent leg treatments like Botox or surgery, or conditions causing regression can't join.Check my eligibility

What is being tested?

The study tests if early intensive exercise for young children's legs, guided by physical therapists and parents together, improves movement more than standard care does. It's a controlled test where some kids get this new method while others continue usual treatment routines.See study design

What are the potential side effects?

Since this trial involves physical exercise as an intervention rather than medication, side effects may include typical responses to increased activity such as muscle soreness or fatigue. However specific side effects will depend on each child's condition.

Eligibility Criteria

Inclusion Criteria

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

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I had a stroke around the time I was born.

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I have weakness on one side of my body.

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My child is between 8 months and 3 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months, 6 months, 9 months, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months, 6 months, 9 months, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months, 9 months, 12 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

Gross Motor Function Measure (GMFM-66) - change from baseline

Secondary outcome measures

Ankle joint angle at full dorsiflexion - change from baseline

Ankle joint angle at onset of stretch reflex - change from baseline

Resource use questionnaire

+2 more

Other outcome measures

Qualitative study using Interpretative Description methodology

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Immediate GroupExperimental Treatment1 Intervention

The intervention is intensive exercise, delivered over 12 weeks beginning on admission to the study. The group will then be followed for 9 months post intervention.

Group II: Delay GroupActive Control1 Intervention

The group will be followed for 6 months with no intervention. After 6 months the group will be given the opportunity to receive the same intensive exercise intervention as the Immediate group. The group will be followed for 3 months following the intervention.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intensive exercise

2011

Completed Phase 4

~450

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

889 Previous Clinical Trials

385,078 Total Patients Enrolled

2 Trials studying Perinatal Stroke

122 Patients Enrolled for Perinatal Stroke

Brain CanadaOTHER

18 Previous Clinical Trials

5,982 Total Patients Enrolled

Jaynie YangPrincipal InvestigatorUniversity of Alberta

1 Previous Clinical Trials

25 Total Patients Enrolled

Media Library

Intensive exercise Clinical Trial Eligibility Overview. Trial Name: NCT03672864 — N/A

Frequently Asked Questions

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

Are there currently any openings for participation in this trial?

"Affirmative, clinicaltrials.gov specifies that this trial is currently recruiting patients; it was initially published on February 15th 2019 and has been recently updated on May 11th 2022. The investigators of the study require 56 participants to be recruited from 4 medical sites."

Answered by AI

Does this medical trial accept participants who are octogenarians?

"In keeping with the requirements for this experiment, only infants between 8 and 36 months of age are eligible to participate."

Answered by AI

How many individuals have been recruited for participation in this trial?

"Affirmative. Clinicaltrials.gov displays that this clinical trial began recruitment on February 15th 2019 and has recently been updated in respect to the 5th of May 2022. 56 individuals are sought from 4 locations for participation."

Answered by AI

What qualifications must one possess to be accepted into this experiment?

"This medical trial is seeking 56 participants with a history of stroke who are between 8 months and 3 years old. To be eligible, these children must exhibit signs of hemiparesis in their upper and/or lower body, have a physical exam that corresponds to perinatal strokes, as well as parental agreement to comply with the testing regime."

Answered by AI

What results are expected from this research endeavor?

"The primary outcome for this 3 to 12 month clinical trial will be a change in Gross Motor Function Measure (GMFM-66) from baseline. Secondary objectives involve assessing changes in Young Children's Participation and Environment Measure (YC-PEM), Portable Spasticity Assessment Device (PSAD)-measured stiffness at the ankle, and Pediatric Quality of Life Measure module for cerebral palsy’s five scales: daily activities, movement/balance, pain/hurt, fatigue, and eating activities."

Answered by AI

Recent research and studies

BMC PediatricsJournal

Parent-therapist Partnership to ELEVATE Gross Motor Function in Children with Perinatal Stroke: Protocol for a Mixed Methods Randomized Controlled Trial

Hurd, Caitlin L., Michelle Barnes, Christa M. Diot, Elizabeth G. Condliffe, Hana Alazem, Lesley Pritchard, Jennifer D. Zwicker, et al.. 2022. “Parent-therapist Partnership to ELEVATE Gross Motor Function in Children with Perinatal Stroke: Protocol for a Mixed Methods Randomized Controlled Trial”. BMC Pediatrics. Springer Science and Business Media LLC. doi:10.1186/s12887-022-03525-6.

clinicaltrials.govStudy

Parent Therapist Partnership to Provide Early, Intensive Exercise in Perinatal Stroke

2019. "Parent Therapist Partnership to Provide Early, Intensive Exercise in Perinatal Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03672864.