The Role of Blood Flow Restriction Therapy in Postop Rehabilitation of Foot and Ankle Injuries

Fracture of Foot Clinical Trial

Official title:

The Role of Blood Flow Restriction Therapy in Postop Rehabilitation of Foot and Ankle Injuries

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05844280
• Other study ID #: IRB-300009735
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2026
• Est. completion date: December 2029

Study information

• Verified date: November 2023
• Source: University of Alabama at Birmingham
• Contact: Patrick Frazier
• Phone: 205-641-0824
• Email: thomasfrazier[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: December 2029
• Est. primary completion date: August 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• isolated, closed low-energy rotational ankle fracture without prior surgery or implants to injured area

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Ankle Injuries
• Fracture of Foot

Intervention

Procedure:
• BFR+NMES at therapeutic level
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 level
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

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess for calf muscle atrophy as measured by calf circumference	Calf circumference will be measured using a measuring tape	2 weeks postop
Primary	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	2 weeks postop
Secondary	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"	2 weeks postop
Secondary	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	2 weeks postop