Achilles Tendon Rupture
Conditions
Keywords
achilles tendon rupture, blood flow restriction
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.
Interventions
DEVICEBlood flow restriction with Delfi Personalized Tourniquet System (PTS)
Standard of care physical therapy exercises with the use of the Delfi PTS cuff
OTHERPhysical therapy
Standard of care physical therapy exercises
Sponsors
The Methodist Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle mass preservation | 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). |
| Bone density preservation | 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). |
| 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. |
| 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 motion | 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. |
| Change in single heel raise repetitions | 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. |
Countries
United States
Contacts
CONTACTHaley Goble
Outcome results
None listed