Effect of BFR Rehab After Achilles Tendon Rupture

The Methodist Hospital Research Institute (TMHRI)

Status: Enrolling

Conditions: Achilles Tendon Rupture

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06254794

Pro00019305

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Blood flow restriction group

Experimental group

Description:

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

Treatment:

Other: Physical therapy

Device: Blood flow restriction with Delfi Personalized Tourniquet System (PTS)

Standard of Care (control) group

Other group

Description:

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

Treatment:

Other: Physical therapy