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

NCT05844280 | Withdrawn

• 1 other identifier: IRB-300009735
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fracture of Foot

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Patient tolerance of the BFR treatment using the Visual Analogue Pain Scale.

  2 weeks postop

• Patient tolerance of the BFR treatment using the the Borg Rating of Perceived Exertion f

  2 weeks postop

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

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

Procedure: BFR+NMES at therapeutic level

Interventions

BFR+NMES at therapeutic level PROCEDURE

This group will receive therapy with BFR+NMES devices used at settings that are deemed by prior studies to be therapeutic.

Treatment Group

BFR+NMES at sub therapeutic level PROCEDURE

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

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: May 6, 2023
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share