Clinical trial NCT06254794: Effect of BFR Rehab After Achilles Tendon Rupture
Official title: Effect of Blood Flow Restriction (BFR) Rehabilitation After Achilles Tendon Rupture Reconstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Achilles Tendon Rupture
Keywords: achilles tendon rupture
blood flow restriction
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Muscle mass preservation
timeFrame: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op
measure: Bone density preservation
timeFrame: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op
measure: Improve patient reported outcomes (Physical activity)
timeFrame: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op
measure: Improve patient reported outcomes (Pain)
timeFrame: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op
measure: Improve patient reported outcomes (Achilles tendon survey)
timeFrame: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op
measure: Change in range of motion
timeFrame: Starting 4 weeks post op, patient will go to physical therapy twice a week until week 16.
measure: Change in single heel raise repetitions
timeFrame: Starting 4 weeks post op, patient will go to physical therapy twice a week until week 16.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
References: