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ACTIVE NOT RECRUITING
NCT06136286
NA

ORIF Distal Radius Blood Flow Restriction Therapy

Sponsor: The Methodist Hospital Research Institute

View on ClinicalTrials.gov

Summary

Patients commonly experience a significant amount of muscular atrophy following open reduction internal fixation (ORIF) surgery of distal radius fractures, associated with an increased risk of re-injury, and an increase in time of recovery. A combination of low intensity resistance exercise and blood flow restriction (BFR) therapy has been shown to elicit responses similar to high intensity resistance exercise with reduced risk. We hypothesize that chronic low intensity resistance exercise combined with BFR will improve muscular strength, reduce skeletal muscle atrophy, and will enhance recovery. Therefore, the specific aims of this study are as follows: 1. Determine if BFR added to standard post-operative rehab will prevent skeletal muscle atrophy and promote skeletal muscle growth during 12-weeks of rehab training compared to traditional rehab alone. The working hypothesis, founded on previous literature, is that combined rehab and BFR will enhance skeletal muscle growth and prevent atrophy to a greater extent than rehab alone. 2. Determine if BFR added to standard post-operative rehab will improve muscular strength following surgery compared to traditional rehab alone. Because strength can be attributed to skeletal muscle mass, the working hypothesis, founded on previous literature, is that combined rehab and BFR will enhance skeletal muscle strength and fatigue resistance to a greater extent than rehab alone. 3. Determine if BFR added to standard post-operative rehab will improve functional outcomes following surgery compared to traditional rehab alone. The working hypothesis, founded on previous literature is that BFR will improve functional outcomes over rehab alone.

Official title: Effects of Blood Flow Restriction Rehabilitation After ORIF of Distal Radius Fractures

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2019-10-22

Completion Date

2027-01-01

Last Updated

2026-04-06

Healthy Volunteers

No

Interventions

DEVICE

Blood Flow Restriction (BFR) Cuff

The intervention group will receive therapy with a blood flow restriction cuff that restricts blood flow at their individual limb occlusion pressure during specific exercises.

Locations (1)

Houston Methodist Hospital

Houston, Texas, United States