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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Standard of care physical therapy exercises with the use of the Delfi PTS cuff
Standard of care physical therapy exercises
Houston Methodist Hospital
Houston, Texas, United States
RECRUITINGMuscle mass preservation
Lean mass for lower extremity measured in kilograms (kg) using Dual-Energy-Xray-Absorptiometry (DEXA).
Time frame: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op
Bone density preservation
Bone mineral content measured in grams using Dual-Energy-Xray-Absorptiometry (DEXA).
Time frame: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op
Improve patient reported outcomes (Physical activity)
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.
Time frame: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op
Improve patient reported outcomes (Pain)
Digital RedCap survey tool sends Pain Visual Analog Scale asking patients to rate their pain from 0 (no pain) to 100 (worst pain possible).
Time frame: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op
Improve patient reported outcomes (Achilles tendon survey)
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.
Time frame: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op
Change in range of motion
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.
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Time frame: Starting 4 weeks post op, patient will go to physical therapy twice a week until week 16.
Change in single heel raise repetitions
Physical therapy will count how many heel raises can be done at each timepoint.
Time frame: Starting 4 weeks post op, patient will go to physical therapy twice a week until week 16.