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Blood Flow Restriction Training in Patients With Lower Extremity Fractures

NCT06496035 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-11-21

No results posted yet for this study

Summary

This study will look at the effect of using a blood flow restriction device during low load strengthening exercises on patients with tibial shaft fractures, compared to patients performing exercise without the device. The study will compare muscle strength, muscle size, fracture healing, and return to normal function between the two groups.

Conditions

  • Tibial Fractures
  • Lower Extremity Fracture

Interventions

DEVICE

Blood Flow Restriction with low load exercise

Cuff/tourniquet will be applied to proximal leg at hip crease and inflated to 60-80% of limb occlusion pressure to decrease venous blood flow in the limb while performing exercise.

OTHER

Therapeutic Exercise

Exercise performed at appropriate load as guided by physical therapist

Sponsors & Collaborators

  • Denver Health and Hospital Authority

    lead OTHER

Principal Investigators

  • Megan E Smith, PT, DPT · Denver Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06496035 on ClinicalTrials.gov