Ankle Sprain 1St DegreeNCT05596162
The Effect of Low-Intensity Blood Flow Restriction Therapy on the Management of Acute Ankle Sprains
A study testing Blood Flow Restriction Therapy and Standard Physical Therapy in people with Ankle Sprain 1St Degree and Ankle Sprain 2Nd Degree, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Sprain 1St Degree, Ankle Sprain 2Nd Degree, Musculoskeletal Injury
- What is being tested?
- Blood Flow Restriction Therapy and Standard Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will include English speaking student athletes aged 18 and older with clinical diagnosis of an isolated grade I or II lateral ankle sprain
Who cannot join
- History of DVT/PE, clotting disordered, peripheral arterial disease, hypertension (BP>140/90), coronary artery disease, or pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Blood Flow Restriction Therapy, Standard Physical Therapy
- Keywords
- blood flow restriction, ankle sprain
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction TherapyOther
Exercise with Blood Flow Restriction
Standard Physical TherapyOther
Exercise without Blood Flow Restriction
| Study group | Role | What they receive |
|---|---|---|
| Blood Flow Restriction Group | Experimental | 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. Receives: Other: Blood Flow Restriction Therapy |
| Non-Blood Flow Restriction Group | Active comparator | This group will perform the same exercises for the same volume without the use of BFR. Receives: Other: Standard Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Return to Play
Time from injury to to when injured ankle regains 90% plantarflexion strength compared to uninjured/contralateral side, using a dynamometer.
Measured: From Time of Injury to 8 weeks after Injury
Secondary outcomes (5)
Pain Level
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.
Measured: Initial visit & 1, 2, 4, and 8 weeks after the initial visit
Range of Motion
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.
Measured: Initial visit & 1, 2, 4, and 8 weeks after the initial visit
Strength Testing
Strength testing of ankle dorsiflexion, plantarflexion, inversion, and eversion. It will be measured from 0 to 5 with higher scores meaning a better outcome.
Measured: Initial visit & 1, 2, 4, and 8 weeks after the initial visit
The Foot and Ankle Ability Measure (FAAM) Patient-Reported Score
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.
Measured: Initial visit & 1, 2, 4, and 8 weeks after the initial visit
Foot and Ankle Outcome Score (FAOS) Patient-Reported Score
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.
Measured: Initial visit & 1, 2, 4, and 8 weeks after the initial visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start17 Oct 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Why it stopped: No support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle Sprain 1St DegreeStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric N. Bowman, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596162
- Sponsor's protocol ID
- 220838
- Status last verified
- Jan 2025
- First submitted
- 16 Oct 2022
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low-Intensity Blood Flow Restriction Therapy on the Management of Acute Ankle Sprains
- ClinicalTrials.gov ID
- NCT05596162
- Acronym / sponsor ID
- 220838
- Keywords
- blood flow restriction, ankle sprain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No support
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood Flow Restriction Group | Experimental | Other: Blood Flow Restriction Therapy1. 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. |
| Non-Blood Flow Restriction Group | Active comparator | Other: Standard Physical TherapyThis group will perform the same exercises for the same volume without the use of BFR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients will include English speaking student athletes aged 18 and older with clinical diagnosis of an isolated grade I or II lateral ankle sprain
Key exclusion criteria (1 listed)
- History of DVT/PE, clotting disordered, peripheral arterial disease, hypertension (BP>140/90), coronary artery disease, or pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Flow Restriction TherapyExercise with Blood Flow Restriction | Other | Blood Flow Restriction Group |
| Standard Physical TherapyExercise without Blood Flow Restriction | Other | Non-Blood Flow Restriction Group |
Primary outcome
Time to Return to Play
Time frame: 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.
5 secondary outcomes
Pain Level
Time frame: Initial visit & 1, 2, 4, and 8 weeks after the initial visit
Range of Motion
Time frame: Initial visit & 1, 2, 4, and 8 weeks after the initial visit
Strength Testing
Time frame: Initial visit & 1, 2, 4, and 8 weeks after the initial visit
The Foot and Ankle Ability Measure (FAAM) Patient-Reported Score
Time frame: Initial visit & 1, 2, 4, and 8 weeks after the initial visit
Foot and Ankle Outcome Score (FAOS) Patient-Reported Score
Time frame: Initial visit & 1, 2, 4, and 8 weeks after the initial visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction Therapy and Standard Physical Therapy in people with Ankle Sprain 1St Degree and Ankle Sprain 2Nd Degree, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Return to Play (time frame: From Time of Injury to 8 weeks after Injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.