Effect of BFR Rehab After Achilles Tendon Rupture

NCT06254794 | Recruiting FDA Device

• 1 other identifier: Pro00019305
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Achilles Tendon Rupture

Keywords

achilles tendon rupture; blood flow restriction

Outcome Measures

Primary Outcomes (7)

• 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 (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

• 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.

Study Arms (2)

Blood flow restriction group

EXPERIMENTAL

The study group will undergo normal Achilles tendon rupture reconstruction rehab modified by use of a tourniquet for blood flow restriction during selected exercises.

Device: Blood flow restriction with Delfi Personalized Tourniquet System (PTS); Other: Physical therapy

Standard of Care (control) group

OTHER

The control group will undergo the normal Achilles tendon rupture reconstruction rehab protocol as determined by Drs. Varner and McCulloch.

Other: Physical therapy

Interventions

Blood flow restriction with Delfi Personalized Tourniquet System (PTS) DEVICE

Standard of care physical therapy exercises with the use of the Delfi PTS cuff

Blood flow restriction group

Physical therapy OTHER

Standard of care physical therapy exercises

Blood flow restriction group; Standard of Care (control) group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Central Study Contacts

Haley Goble

CONTACT

713.441.3930; hmgoble@houstonmethodist.org

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: The John S. Dunn Chair in Orthopedic Surgery, Professor of Clinical Orthopedic Surgery, Vice-Chairman Dept. of Orthopedic Surgery, Head Team Physician: Rice University, Team Physician / Consultant: MLB, Houston Ballet, NASA Astronaut Corps.

Model Details: The Delfi PTS device for BFR allows for a systematic and customized approach to BFR training in the clinic. This instrument provides a digital display of pressure, inflation time, and provides the user with an interface to control the tourniquet system. Pressure is monitored and regulated continuously to compensate for changing levels in the cuff during movement. Each cuff is specifically designed for the tapered contour of a body limb (arm or leg) and sized appropriately based on body region. These cuffs only work with the Delfi PTS device and allow for comfortable pressure application. Exercise will be performed with the cuff placed around the proximal limb and inflated through the duration of activity (\~5 minutes), then immediately deflated.

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: February 12, 2024
• Study Start: November 13, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)