Blood Flow Restriction Training in Patients With Lower Extremity Fractures

Part of paid clinical trials in Denver, Colorado.

Sponsor
Denver Health and Hospital Authority
Study ID
NCT06496035
Status
Recruiting
Apply to this trial

Conditions

  • Lower Extremity Fracture
  • Tibial Fractures

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • Blood Flow Restriction with low load exercise — DEVICE
    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.
  • Therapeutic Exercise — OTHER
    Exercise performed at appropriate load as guided by physical therapist

Study Details

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.

Key Dates

Start date
Nov 1, 2024
Status verified
Oct 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Blood flow restriction training
    Patients will perform exercises as directed by a Doctor of Physical Therapy with the use of blood flow restriction device
  • Active Comparator: Traditional physical therapy
    Patients perform physical therapy exercises guided by a Doctor of Physical Therapy without the use of a blood flow restriction device, as is current standard practice.

Primary Outcome Measure

Fracture healing [ Time Frame: 6 weeks, 12 weeks, 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Denver Health Medical CenterDenverColorado80204
Megan E Smith, PT, DPT
[email protected]
651-319-1730
Mathew A Haager, PT, DPT
[email protected]
5639407061

Find similar trials in Denver, CO

By research site
Denver Health Medical Center· Denver, CO

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