passive range of motion exercise therapy for Congenital Heart Disease

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
The Hospital For Sick Children, Toronto, CanadaCongenital Heart Diseasepassive range of motion exercise therapy - Other
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test if a passive ROM exercise program can improve the movement of infants with HLHS and other single right ventricle anomalies following the Norwood procedure.

Eligible Conditions
  • Congenital Heart Disease

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
BM-MSC
1
Ultrafiltration
1
Oxandrolone

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first

Month 4
DXA
Tests of Infant Motor Performance (TIMP)
head circumference-for-age z-score
length-for-age z-score
weight-for-age z-score
Day 21
NICU Neonatal Neurobehavioral Scale (NNNS) subdomain scores

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
BM-MSC
2
Ultrafiltration
1
Oxandrolone

Trial Design

2 Treatment Groups

Standard of care
1 of 2
Passive range-of-motion
1 of 2

Active Control

Experimental Treatment

238 Total Participants · 2 Treatment Groups

Primary Treatment: passive range of motion exercise therapy · No Placebo Group · Phase 3

Passive range-of-motion
Other
Experimental Group · 1 Intervention: passive range of motion exercise therapy · Intervention Types: Other
Standard of careNoIntervention Group · 1 Intervention: Standard of care · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 4 months of age or superior cavopulmonary connection (scpc) evaluation clinic visit, whichever comes first

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,623 Previous Clinical Trials
47,121,529 Total Patients Enrolled
HealthCore-NERILead Sponsor
72 Previous Clinical Trials
206,545 Total Patients Enrolled

Eligibility Criteria

Age < 18 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are scheduled for a Norwood procedure.
References

Frequently Asked Questions

How often do patients report negative side effects from passive range of motion exercise therapy?

"There is available clinical evidence supporting the safety of passive range of motion exercise therapy, so it received a score of 3." - Anonymous Online Contributor

Unverified Answer

Would it be easy for me to find a clinical trial location near me?

"The primary locations for this trial are Boston Children's Hospital, Children's Healthcare of Atlanta / Emory University, and Texas Children's Hospital / Baylor. Additionally, there are 10 other places where this trial is taking place." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top