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NCT Number: NCT06254794

Effect of BFR Rehab After Achilles Tendon Rupture

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.

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Key information

Conditions

Achilles Tendon Rupture

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Haley M Goble, MHA

CONTACT

[email protected]

713-441-3930

Patrick C McCulloch, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood flow restriction with Delfi Personalized Tourniquet System (PTS)

Device

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

Physical Therapy

Other

Standard of care physical therapy exercises

Primary outcomes

  1. Muscle mass preservation

    Time frame: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op

    Lean mass for lower extremity measured in kilograms (kg) using Dual-Energy-Xray-Absorptiometry (DEXA).

  2. Bone density preservation

    Time frame: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op

    Bone mineral content measured in grams using Dual-Energy-Xray-Absorptiometry (DEXA).

  3. Improve patient reported outcomes (Physical activity)

    Time frame: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op

    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.

  4. Improve patient reported outcomes (Pain)

    Time frame: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op

    Digital RedCap survey tool sends Pain Visual Analog Scale asking patients to rate their pain from 0 (no pain) to 100 (worst pain possible).

  5. Improve patient reported outcomes (Achilles tendon survey)

    Time frame: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op

    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.

  6. Change in range of motion

    Time frame: Starting 4 weeks post op, patient will go to physical therapy twice a week until week 16.

    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.

  7. Change in single heel raise repetitions

    Time frame: Starting 4 weeks post op, patient will go to physical therapy twice a week until week 16.

    Physical therapy will count how many heel raises can be done at each timepoint.

Study contacts

Contact information is provided by the study sponsor or research team.

Haley Goble

CONTACT

[email protected]

713.441.3930

Sponsors and collaborators

Lead sponsor

The Methodist Hospital Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2026
Study completion
2028
First posted
Feb 12, 2024
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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