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

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.

Study Overview

• Status: Withdrawn
• Conditions: Fracture of Foot
• Intervention / Treatment: Procedure: BFR+NMES at sub therapeutic level; Procedure: BFR+NMES at therapeutic level

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; receiving physical therapy with BFR+NMES devices used at sub-therapeutic levels	Procedure: 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
Experimental: Treatment Group; receiving physical therapy with BFR+NMES devices used at settings that are deemed by prior studies to be therapeutic	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess for calf muscle atrophy as measured by calf circumference	Calf circumference will be measured using a measuring tape	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	2 weeks postop

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: March 2, 2023
• First Submitted That Met QC Criteria: May 3, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Ankle Injuries
• Other Study ID Numbers: IRB-300009735

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No