Blood Flow Restriction Therapy in Lower Limb Extensor Injuries

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT04149977
Status
Recruiting
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Conditions

  • Lower Limb Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Physical Therapy with pressure cuff — BEHAVIORAL
    6 weeks of physical therapy will have similar exercises to standard therapy however the patients will use a cuff around the affected leg during the exercises.
  • Physical Therapy with placebo pressure cuff — BEHAVIORAL
    6 weeks of physical therapy will have similar exercises to standard therapy however the patients will use a pressure cuff around the affected leg during the exercises. The pressure cuff will have 50% of the pressure that will be considered effective.

Study Details

The primary objective of the study is to determine the efficacy of blood flow restriction therapy on patients with lower limb extensor injuries by measuring pre and post blood flow restriction therapy strength and muscle mass.

Key Dates

Start date
Sep 1, 2021
Status verified
Sep 2025
Primary completion
Feb 1, 2026
Completion
Jun 1, 2026

Study Design

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

Arms

  • Experimental: blood flow restriction therapy (pressure cuff)
    The cuff will be placed around the upper thigh of the injured leg and set at a pressure that will prevent approximately 80% arterial blood flow. The machine will determine what pressure is required to reach that 80%, when placed on the leg and turned on.
  • Placebo Comparator: blood flow restriction therapy (placebo)
    Patients with a placebo pressure will have a pressure setting, 50% lower than the effective setting as stated in the experimental arm

Primary Outcome Measure

Change in extensor strength of both legs [ Time Frame: Visit 1 Day 0 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016
Dhruv Shankar
[email protected]
240-848-8645
Guillem Gonzalez-Lomas, MD (PRINCIPAL_INVESTIGATOR)

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NYU Langone Health· New York, NY

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