Effect of BFR Rehab After Achilles Tendon Rupture

Effect of Blood Flow Restriction (BFR) Rehabilitation After Achilles Tendon Rupture Reconstruction

The purpose of this study is to determine if blood flow restriction therapy after Achilles tendon rupture reconstruction decreases post-operative calf atrophy, improves reported outcomes, and ultimately decreases return to play time.

Study Overview

• Status: Recruiting
• Conditions: Achilles Tendon Rupture
• Intervention / Treatment: Other: Physical therapy; Device: Blood flow restriction with Delfi Personalized Tourniquet System (PTS)

Detailed Description

The purpose of this research study is to determine if the use of Blood Flow Restriction, BFR, therapy in addition to standard physical therapy (PT) for post-Achilles tendon rupture reconstruction will decrease post-operative muscle atrophy (loss of muscle), increases dorsal and planar ankle flexion (range of motion), increase strength, and ultimately decrease return to play time for the BFR therapy group as compared to the control group.

Participants in this study will be randomly divided into either BFR group that will receive BFR therapy in addition to standard physical therapy protocol post-operatively or the control group which will undergo the standard PT protocol. All participants will complete full body composition scans (DEXA) and questionnaires before surgery, prior to physical therapy (three weeks post-op), eight weeks post-op, and 16 weeks post-op. Subjective and objective measures will be taken at physical therapy eight weeks and 16 weeks post-operatively.

• Study Type: Interventional
• Enrollment (Estimated): 19
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haley Goble; Phone Number: 713.441.3930; Email: hmgoble@houstonmethodist.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist Hospital
      • Principal Investigator: Patrick C McCulloch, MD
      • Contact: Haley M Goble, MHA; Phone Number: 713-441-3930; Email: hmgoble@houstonmethodist.org

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Achilles Rupture confirmed by MRI or Thompson Test
• Adult
• Receiving Percutaneous Achilles Repair System (PARS) or open repair
• Proposed PT with Methodist Location

Exclusion Criteria:

• Obesity (BMI>35)
• Diabetes
• Cardiovascular, renal, liver or pulmonary disease
• Active infections
• Cancer (current or treated within the past 2 years) or coagulation disorder
• Physically unable to participate in the intervention
• Unable to complete a minimum of 85% of the assigned rehabilitation sessions
• Less than 18 years of age
• Pregnant

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
Experimental: Blood flow restriction group; The study group will undergo normal Achilles tendon rupture reconstruction rehab modified by use of a tourniquet for blood flow restriction during selected exercises.	Other: Physical therapy; Standard of care physical therapy exercises; Device: Blood flow restriction with Delfi Personalized Tourniquet System (PTS); Standard of care physical therapy exercises with the use of the Delfi PTS cuff
Other: Standard of Care (control) group; The control group will undergo the normal Achilles tendon rupture reconstruction rehab protocol as determined by Drs. Varner and McCulloch.	Other: Physical therapy; Standard of care physical therapy exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle mass preservation	Lean mass for lower extremity measured in kilograms (kg) using Dual-Energy-Xray-Absorptiometry (DEXA).	pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op
Bone density preservation	Bone mineral content measured in grams using Dual-Energy-Xray-Absorptiometry (DEXA).	pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op
Improve patient reported outcomes (Pain)	Digital RedCap survey tool sends Pain Visual Analog Scale asking patients to rate their pain from 0 (no pain) to 100 (worst pain possible).	pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op
Improve patient reported outcomes (Achilles tendon survey)	Digital RedCap survey tool sends Achilles Tendon Rupture Score (ATRS) survey. This survey asks 10 questions where the patient answers from 0=major limitation to 10=No limitations. High scores point to better physical activity.	pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op
Change in range of motion	Physical therapy will do functional assessments including: leg squat depth, Y balance anterior, y balance posteromedial, y balance posterolateral and measure in centimeters (cm). The measurements will be taken at each physical therapy appointment and compared at the end of the study.	Starting 4 weeks post op, patient will go to physical therapy twice a week until week 16.
Change in single heel raise repetitions	Physical therapy will count how many heel raises can be done at each timepoint.	Starting 4 weeks post op, patient will go to physical therapy twice a week until week 16.
Improve patient reported outcomes (Physical activity)	Digital RedCap survey tool sends Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function survey which consists of questions about their physical health and patient responds with Excellent, Very Good, Good, Fair or poor. Using healthmeasures.net, responses are converted to T-scores based on the general population. The highest the T-scores, the better physical health the patient has.	pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op

Collaborators and Investigators

• Sponsor: The Methodist Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2018
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 22, 2023
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: blood flow restriction; achilles tendon rupture
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: Pro00019305

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: Yes
• product manufactured in and exported from the U.S.: No