Fracture of FootNCT05844280
The Role of Blood Flow Restriction Therapy in Postop Rehabilitation of Foot and Ankle Injuries
A study testing BFR+NMES at therapeutic level and BFR+NMES at sub therapeutic level in people with Fracture of Foot, run by University of Alabama at Birmingham.
Trial summary
The purpose of the study is to determine the role of blood flow restriction (BFR) + neuromuscular electrical stimulation (NMES) in improving post-operative physical therapy and recovery after ankle fracture surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture of Foot
- What is being tested?
- BFR+NMES at therapeutic level and BFR+NMES at sub therapeutic level
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Dec 2029
- 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
- isolated, closed low-energy rotational ankle fracture without prior surgery or implants to injured area
Who cannot join
- history of Deep Vein Thrombosis in affected extremity
- history of significant cardiac disease defined as a recent stent placement in past
- history of peripheral arterial disease
- history of sickle cell disease
- history of coagulopathy
- presenting to surgery >14 days after injury
About this study
The purpose of the study is to determine the role of blood flow restriction (BFR) + neuromuscular electrical stimulation (NMES) in improving post-operative physical therapy and recovery after ankle fracture surgery. We expect to see improved muscle strength, less muscle wasting, and improved functional recovery after surgery when making these additions to routine post-operative (postop) physical therapy protocols.
Read the detailed description
Few studies have examined BFR in patients sustaining operative foot and ankle injuries. Due to the weight bearing limitations and prolonged immobilization following these injuries, patients often experience increased time away from work and delays with return to sport. These factors are responsible for the rapid muscle atrophy that occurs in the immediate post injury period because of immobility and disuse. Recently, blood flow restriction (BFR) therapy has been shown to be effective in improving muscle strength and preventing atrophy when combined with low load resistance training physical therapy programs.7,8 Neuromuscular electrical stimulation (NMES) is an adjunctive agent that has been show to augment the effects of BFR alone.4 The null hypothesis is that a 2 week BFR + NMES + low load resistance training program in patients age >= 18 recovering from foot and ankle surgery will have no effect on short term (2 weeks postop) lower extremity muscle hypertrophy or atrophy, patient pain and satisfaction, or functional recovery after foot and ankle surgery.
- Conditions
- Fracture of Foot
- Being tested
- BFR+NMES at therapeutic level, BFR+NMES at sub therapeutic level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BFR+NMES at therapeutic levelProcedure or surgery
This group will receive therapy with BFR+NMES devices used at settings that are deemed by prior studies to be therapeutic.
BFR+NMES at sub therapeutic levelProcedure or surgery
This means that the BFR tourniquet and the NMES device will be at such low settings as to not create the treatment effect but subject will have the equipments on their thigh during exercise
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | receiving physical therapy with BFR+NMES devices used at sub-therapeutic levels Receives: Procedure: BFR+NMES at sub therapeutic level |
| Treatment Group | Experimental | receiving physical therapy with BFR+NMES devices used at settings that are deemed by prior studies to be therapeutic Receives: Procedure: BFR+NMES at therapeutic level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess for calf muscle atrophy as measured by calf circumference
Calf circumference will be measured using a measuring tape
Measured: 2 weeks postop
Assess for calf muscle atrophy as measured by hand held dynamometry
Hand held Dynamometry will be used to measure the length-tension relationship of the muscle in pounds
Measured: 2 weeks postop
Secondary outcomes (2)
Patient tolerance of the BFR treatment using the Visual Analogue Pain Scale.
The Visual Analogue Pain Scale is used during the beginning, midpoint, and end of a session.
This scale ranges from 0-10 which 0 being "no pain" and 10 being "worst pain"
Measured: 2 weeks postop
Patient tolerance of the BFR treatment using the the Borg Rating of Perceived Exertion f
The Borg Rating of Perceived Exertion will be used for each session and exercise.
This rating ranges from 6-20 with 6 being no exertion at all, and 20 being maximum effort
Measured: 2 weeks postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study startAug 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionDec 2029 (estimated)
Why it stopped: study never opened
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture of FootStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Johnson, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844280
- Sponsor's protocol ID
- IRB-300009735
- Status last verified
- Dec 2024
- First submitted
- 2 Mar 2023
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Blood Flow Restriction Therapy in Postop Rehabilitation of Foot and Ankle Injuries
- ClinicalTrials.gov ID
- NCT05844280
- Acronym / sponsor ID
- IRB-300009735
- Conditions
- Fracture of Foot
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study never opened
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 6 May 2023 (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 purpose of the study is to determine the role of blood flow restriction (BFR) + neuromuscular electrical stimulation (NMES) in improving post-operative physical therapy and recovery after ankle fracture surgery. We expect to see improved muscle strength, less muscle wasting, and improved functional recovery after surgery when making these additions to routine post-operative (postop) physical therapy protocols.
Detailed description
Few studies have examined BFR in patients sustaining operative foot and ankle injuries. Due to the weight bearing limitations and prolonged immobilization following these injuries, patients often experience increased time away from work and delays with return to sport. These factors are responsible for the rapid muscle atrophy that occurs in the immediate post injury period because of immobility and disuse. Recently, blood flow restriction (BFR) therapy has been shown to be effective in improving muscle strength and preventing atrophy when combined with low load resistance training physical therapy programs.7,8 Neuromuscular electrical stimulation (NMES) is an adjunctive agent that has been show to augment the effects of BFR alone.4 The null hypothesis is that a 2 week BFR + NMES + low load resistance training program in patients age >= 18 recovering from foot and ankle surgery will have no effect on short term (2 weeks postop) lower extremity muscle hypertrophy or atrophy, patient pain and satisfaction, or functional recovery after foot and ankle surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Procedure: BFR+NMES at sub therapeutic levelreceiving physical therapy with BFR+NMES devices used at sub-therapeutic levels |
| Treatment Group | Experimental | Procedure: BFR+NMES at therapeutic levelreceiving physical therapy with BFR+NMES devices used at settings that are deemed by prior studies to be therapeutic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- isolated, closed low-energy rotational ankle fracture without prior surgery or implants to injured area
Key exclusion criteria (6 listed)
- history of Deep Vein Thrombosis in affected extremity
- history of significant cardiac disease defined as a recent stent placement in past
- history of peripheral arterial disease
- history of sickle cell disease
- history of coagulopathy
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 |
|---|---|---|
| BFR+NMES at therapeutic levelThis group will receive therapy with BFR+NMES devices used at settings that are deemed by prior studies to be therapeutic. | Procedure or surgery | Treatment Group |
| BFR+NMES at sub therapeutic levelThis means that the BFR tourniquet and the NMES device will be at such low settings as to not create the treatment effect but subject will have the equipments on their thigh during exercise | Procedure or surgery | Control Group |
Primary outcome
Assess for calf muscle atrophy as measured by calf circumference
Time frame: 2 weeks postop
Calf circumference will be measured using a measuring tape
Assess for calf muscle atrophy as measured by hand held dynamometry
Time frame: 2 weeks postop
Hand held Dynamometry will be used to measure the length-tension relationship of the muscle in pounds
2 secondary outcomes
Patient tolerance of the BFR treatment using the Visual Analogue Pain Scale.
Time frame: 2 weeks postop
Patient tolerance of the BFR treatment using the the Borg Rating of Perceived Exertion f
Time frame: 2 weeks postop
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 9 Dec 2024.
- Individual participant dataSharing planned: No
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Medial Malleolus Fracture, Lisfranc Injury
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Evaluate the Continued Safety and Performance of the Foot and Ankle Products
Hyperpronated Foot, Reconstruction Surgeries of the Foot
Not yet recruitingPhase 4
Compression Therapy for Swelling Management Following Ankle Injury
Ankle Fracture, Ankle Arthrodesis
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.
Questions about this trial
What is this clinical trial studying?
A study testing BFR+NMES at therapeutic level and BFR+NMES at sub therapeutic level in people with Fracture of Foot, run by University of Alabama at Birmingham.
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 6 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 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Assess for calf muscle atrophy as measured by calf circumference (time frame: 2 weeks postop). The study lists 2 primary outcomes in all. 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 9 Dec 2024.