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

Primary Purpose

Fracture of Foot

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BFR+NMES at therapeutic level
BFR+NMES at sub therapeutic level
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fracture of Foot

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Treatment Group

Arm Description

receiving physical therapy with BFR+NMES devices used at sub-therapeutic levels

receiving physical therapy with BFR+NMES devices used at settings that are deemed by prior studies to be therapeutic

Outcomes

Primary Outcome Measures

Assess for calf muscle atrophy as measured by calf circumference
Calf circumference will be measured using a measuring tape
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

Secondary Outcome Measures

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"
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

Full Information

First Posted
March 2, 2023
Last Updated
May 3, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT05844280
Brief Title
The Role of Blood Flow Restriction Therapy in Postop Rehabilitation of Foot and Ankle Injuries
Official Title
The Role of Blood Flow Restriction Therapy in Postop Rehabilitation of Foot and Ankle Injuries
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture of Foot

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
receiving physical therapy with BFR+NMES devices used at sub-therapeutic levels
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
receiving physical therapy with BFR+NMES devices used at settings that are deemed by prior studies to be therapeutic
Intervention Type
Procedure
Intervention Name(s)
BFR+NMES at therapeutic level
Intervention Description
This group will receive therapy with BFR+NMES devices used at settings that are deemed by prior studies to be therapeutic.
Intervention Type
Procedure
Intervention Name(s)
BFR+NMES at sub therapeutic level
Intervention Description
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
Primary Outcome Measure Information:
Title
Assess for calf muscle atrophy as measured by calf circumference
Description
Calf circumference will be measured using a measuring tape
Time Frame
2 weeks postop
Title
Assess for calf muscle atrophy as measured by hand held dynamometry
Description
Hand held Dynamometry will be used to measure the length-tension relationship of the muscle in pounds
Time Frame
2 weeks postop
Secondary Outcome Measure Information:
Title
Patient tolerance of the BFR treatment using the Visual Analogue Pain Scale.
Description
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"
Time Frame
2 weeks postop
Title
Patient tolerance of the BFR treatment using the the Borg Rating of Perceived Exertion f
Description
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
Time Frame
2 weeks postop

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Frazier
Phone
205-641-0824
Email
thomasfrazier@uabmc.edu
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Frazier, MBA
Phone
205-641-0824
Email
thomasfrazier@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Michael Johnson, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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