Effect of BFR Rehab After Achilles Tendon Rupture

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-13

Study Completion Date

2028-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Achilles Tendon Rupture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Blood flow restriction with Delfi Personalized Tourniquet System (PTS)

Intervention Type DEVICE

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

Physical therapy

Intervention Type OTHER

Standard of care physical therapy exercises

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.

Group Type OTHER

Physical therapy

Intervention Type OTHER

Standard of care physical therapy exercises

Interventions

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Blood flow restriction with Delfi Personalized Tourniquet System (PTS)

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

Intervention Type DEVICE

Physical therapy

Standard of care physical therapy exercises

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Patrick McCulloch,MD

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.

Responsibility Role PRINCIPAL_INVESTIGATOR