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Blood Flow Restriction Therapy for Distal Radius Fracture (ORIF DR BFR Trial)

N/A

Recruiting

Led By Shari Liberman, MD

Research Sponsored by The Methodist Hospital Research Institute

Eligibility Criteria Checklist

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

Must have

With acute fracture of distal radius requiring ORIF surgery

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up this survey will be conducted before surgery, prior to physical therapy rehabilitation at two weeks post-op, then at two months, six months and one year post-operatively.

Awards & highlights

ORIF DR BFR Trial Summary

This trial studies if adding blood flow restriction therapy to standard post-op rehab helps reduce muscular atrophy, improve strength, and enhance recovery from ORIF surgery on distal radius fractures.

Who is the study for?

This trial is for adults over 18 who need surgery (ORIF) for a broken wrist at the end of the forearm bone. It's not suitable for those with severe pain, previous injuries or surgeries to that arm, extreme obesity, diabetes type II, major organ diseases, active infections, recent cancer history, bleeding disorders, significant weight changes in the last year, inability to do rehab exercises or those on certain medications.Check my eligibility

What is being tested?

The study tests if adding Blood Flow Restriction (BFR) therapy to standard post-surgery rehab can better prevent muscle loss and improve strength and recovery after wrist fracture surgery. Participants will undergo low intensity resistance exercise with BFR cuff as part of their rehabilitation routine.See study design

What are the potential side effects?

While specific side effects are not detailed here, generally BFR might cause discomfort due to restricted blood flow during exercise sessions. There may also be risks associated with low-intensity resistance training following ORIF surgery.

ORIF DR BFR Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I need surgery for a broken wrist bone.

ORIF DR BFR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ this survey will be conducted before surgery, prior to physical therapy rehabilitation at two weeks post-op, then at two months, six months and one year post-operatively.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~this survey will be conducted before surgery, prior to physical therapy rehabilitation at two weeks post-op, then at two months, six months and one year post-operatively.

This trial's timeline: 3 weeks for screening, Varies for treatment, and this survey will be conducted before surgery, prior to physical therapy rehabilitation at two weeks post-op, then at two months, six months and one year post-operatively. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Body composition / bone density

Forearm girth

Grip strength

+1 more

Secondary outcome measures

DASH survey

Michigan Hand Outcomes survey

Patient Rated Wrist Evaluation

ORIF DR BFR Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention - Blood Flow Restriction Therapy (BFR)Experimental Treatment1 Intervention

Subjects will undergo standard postoperative rehabilitation that incorporates BFR during certain exercises.

Group II: ControlActive Control1 Intervention

Standard of care postoperative rehabilitation. Subject will undergo standard rehab following surgery without BFR.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor

274 Previous Clinical Trials

80,465 Total Patients Enrolled

Shari Liberman, MDPrincipal InvestigatorThe Methodist Hospital Research Institute

1 Previous Clinical Trials

93 Total Patients Enrolled

Frequently Asked Questions

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

Are there still available slots for prospective participants in this research endeavor?

"Affirmative. Clinicaltrials.gov indicates that this research study, initially submitted on October 22nd 2019, is actively searching for volunteers to join their trial. The medical centre requires 70 participants for the experiment and has 1 site available."

Answered by AI

How many participants may enter into this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this medical trial is still searching for test subjects, which was first posted on October 22nd 2019 and revised lastly on November 14th 2023. 70 patients are required at a single site of the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ORIF Distal Radius Blood Flow Restriction Therapy

Shari Liberman 2019. "ORIF Distal Radius Blood Flow Restriction Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06136286.