The Effect of Low-Intensity Blood Flow Restriction Therapy on the Management of Acute Ankle Sprains

Vanderbilt University Medical Center

Status: Withdrawn

Conditions: Ankle Sprain 2Nd Degree; Musculoskeletal Injury; Ankle Sprain 1St Degree

Treatments: Other: Standard Physical Therapy; Other: Blood Flow Restriction Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05596162

220838

Details and patient eligibility

About

The primary objective of this study is to evaluate the feasibility of implementing BFR in the rehabilitation treatment of isolated ankle sprains as well as to evaluate the clinical benefits of BFR when compared to standard treatment. This study will evaluate the efficacy of using BFR therapy for the treatment of acute grade I and II ankle sprains. The investigators will evaluate clinical outcomes of range of motion (ROM) and strength testing of ankle dorsiflexion, plantarflexion, inversion, and eversion.

This will be a small, randomized control trial study. The investigators will enroll a total of 40 participants, 20 participants will undergo standard physical therapy for isolated lateral ankle sprains and 20 participants will undergo BFR therapy for an isolated lateral ankle sprain. Patients will be randomized into control and experimental group via block randomization.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients will include English speaking student athletes aged 18 and older with clinical diagnosis of an isolated grade I or II lateral ankle sprain

Exclusion criteria

• History of DVT/PE, clotting disordered, peripheral arterial disease, hypertension (BP>140/90), coronary artery disease, or pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Blood Flow Restriction Group

Experimental group

Description:

1. Patient specific tourniquet settings to achieve 80% occlusion. 2. Weight- 20% of 1 rep max, 4 sets 30-15-15-15 reps with 30 second rests between sets 3. Exercises: The first phase will focus on active and passive range of motion of the ankle as well as non-weighted concentric exercises. Phase two will progress with gastrocnemius and soleus stretches along with body weight and light resistance band concentric and eccentric exercises focusing on posterior, anterior and lateral muscle groups of the lower limb. Phase three will introduce weighted, dynamic and proprioceptive exercises.

Treatment:

Other: Blood Flow Restriction Therapy

Non-Blood Flow Restriction Group

Active Comparator group

Description:

This group will perform the same exercises for the same volume without the use of BFR.

Treatment:

Other: Standard Physical Therapy