Ankle Sprain 1St Degree, Ankle Sprain 2Nd Degree, Musculoskeletal Injury
Conditions
Keywords
blood flow restriction, ankle sprain
Brief summary
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.
Interventions
OTHERBlood Flow Restriction Therapy
Exercise with Blood Flow Restriction
OTHERStandard Physical Therapy
Exercise without Blood Flow Restriction
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The assessors will not be aware of group allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Return to Play | From Time of Injury to 8 weeks after Injury | Time from injury to to when injured ankle regains 90% plantarflexion strength compared to uninjured/contralateral side, using a dynamometer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Level | Initial visit & 1, 2, 4, and 8 weeks after the initial visit | Pain will be assessed with the Visual Analog Pain Scale (VAS). The minimum and maximum scores are 0 and 10 respectively with higher scores meaning a worse outcome. |
| Range of Motion | Initial visit & 1, 2, 4, and 8 weeks after the initial visit | Range of motion of ankle dorsiflexion, plantarflexion, inversion, and eversion. It will be measured from 0 to 360 with higher scores meaning a worse outcome. |
| Strength Testing | Initial visit & 1, 2, 4, and 8 weeks after the initial visit | Strength testing of ankle dorsiflexion, plantarflexion, inversion, and eversion. It will be measured from 0 to 5 with higher scores meaning a better outcome. |
| The Foot and Ankle Ability Measure (FAAM) Patient-Reported Score | Initial visit & 1, 2, 4, and 8 weeks after the initial visit | The Foot and Ankle Ability Measure (FAAM) will be used to measure self-reported physical function. It will be measured from 0 to 116 with higher scores meaning a better outcome. |
| Foot and Ankle Outcome Score (FAOS) Patient-Reported Score | Initial visit & 1, 2, 4, and 8 weeks after the initial visit | The Foot and Ankle Outcome Score (FAOS) will be used to measure self-reported physical function. It will be measured from 0 to 100% with higher scores meaning a better outcome. |
Countries
United States
Outcome results
None listed