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Effect of BFR Rehab After Achilles Tendon Rupture

Not Applicable
Recruiting
Conditions
Achilles Tendon Rupture
Interventions
Other: Physical therapy
Device: Blood flow restriction with Delfi Personalized Tourniquet System (PTS)
Registration Number
NCT06254794
Lead Sponsor
The Methodist Hospital Research Institute
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
19
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
Read More
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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Standard of Care (control) groupPhysical therapyThe control group will undergo the normal Achilles tendon rupture reconstruction rehab protocol as determined by Drs. Varner and McCulloch.
Blood flow restriction groupPhysical therapyThe study group will undergo normal Achilles tendon rupture reconstruction rehab modified by use of a tourniquet for blood flow restriction during selected exercises.
Blood flow restriction groupBlood flow restriction with Delfi Personalized Tourniquet System (PTS)The study group will undergo normal Achilles tendon rupture reconstruction rehab modified by use of a tourniquet for blood flow restriction during selected exercises.
Primary Outcome Measures
NameTimeMethod
Muscle mass preservationpre-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).

Bone density preservationpre-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).

Improve patient reported outcomes (Pain)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).

Improve patient reported outcomes (Achilles tendon survey)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.

Change in range of motionStarting 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.

Change in single heel raise repetitionsStarting 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.

Improve patient reported outcomes (Physical activity)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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Houston Methodist Hospital

🇺🇸

Houston, Texas, United States

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