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Blood Flow Restriction Training for Post-Concussion Syndrome

N/A
Waitlist Available
Led By Laura Pietrosimone
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Post-Concussion Syndrome (medical diagnosis of concussion with symptoms lasting greater than four weeks)
Ages 14-30 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week, 3 weeks, 6 weeks, 8 weeks
Awards & highlights

Study Summary

This trial will study whether blood flow restriction training can help patients with concussion who can't tolerate physical activity.

Who is the study for?
This trial is for English-speaking individuals aged 14-30 with Post-Concussion Syndrome, experiencing symptoms over four weeks and worsened by physical activity. It's not suitable for those with open wounds, clot history, circulation issues, sickle cell anemia, infections near the tourniquet area, cancer or lymph removal.Check my eligibility
What is being tested?
The study tests if blood flow restriction training combined with low load exercise can help concussion patients who struggle with regular exercises. The goal is to see if this method can produce benefits similar to high load training without worsening concussive symptoms.See study design
What are the potential side effects?
While blood flow restriction is generally safe and used in various conditions at Duke Sports Physical Therapy, potential side effects may include discomfort at the tourniquet site or temporary changes in skin coloration and sensation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Post-Concussion Syndrome.
Select...
I am between 14 and 30 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week, 3 weeks, 6 weeks, 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week, 3 weeks, 6 weeks, 8 weeks 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 Post Concussion Symptom Score
Secondary outcome measures
Change in Global Function Rating
Change in Heart Rate Variability
Change in Presence of Orthostatic Symptoms (Headache)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Without BFR THEN with BFRExperimental Treatment1 Intervention
Will perform exercises without BFR at the first visit and with BFR at the second visit
Group II: BFR THEN without BFRExperimental Treatment1 Intervention
Will perform exercises with BFR at the first visit and without BFR at the second visit

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,420,059 Total Patients Enrolled
Laura PietrosimonePrincipal InvestigatorDuke University

Media Library

Blood Flow Restriction Training with Exercise (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03695042 — N/A
Post-Concussion Syndrome Research Study Groups: BFR THEN without BFR, Without BFR THEN with BFR
Post-Concussion Syndrome Clinical Trial 2023: Blood Flow Restriction Training with Exercise Highlights & Side Effects. Trial Name: NCT03695042 — N/A
Blood Flow Restriction Training with Exercise (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03695042 — N/A

Frequently Asked Questions

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

Is the study open to elderly participants aged seventy and over?

"This medical trial is inviting all individuals aged between 14 and 30 to apply."

Answered by AI

Is recruitment for this trial still open to the public?

"Clinicaltrials.gov informs us that this medical trial, which initially began on the 15th of January 2019 and finished recruitment on September 12th 2022, is not presently recruiting patients. Nevertheless, at present there are 25 other active clinical studies searching for volunteers."

Answered by AI

Am I eligible to participate in this trial?

"The trial is seeking 10 candidates between the ages of 14 and 30, who have post-concussion syndrome and display enhanced symptoms upon physical effort."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Blood Flow Restriction Concussion
2019. "Blood Flow Restriction Concussion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03695042.
All > Concussion
~1 spots leftby Dec 2024
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