Blood Flow Restriction Therapy for Achilles Tendon Rupture
This study is looking at whether adding blood flow restriction (BFR) therapy to standard physical therapy (PT) after Achilles tendon rupture surgery can help you recover better. BFR therapy uses a special cuff, the Delfi Personalized Tourniquet System (PTS), during exercises. Researchers want to see if this helps keep your calf muscle from shrinking, improves your physical activity, and gets you back to your normal activities faster. You could join if you're an adult with an Achilles tendon rupture confirmed by MRI or Thompson Test, are having surgery (PARS or open repair), and plan to do PT at a Methodist location. The study is currently unclear on its recruitment status.
- Study design
- This is an interventional study with 19 planned participants. You would be randomly assigned to either receive BFR therapy with standard PT or standard PT alone.
- What's involved
- You would have full body composition scans (DEXA) and questionnaires before surgery, and then at 3, 8, and 16 weeks after surgery. Other measurements would be taken at physical therapy at 8 and 16 weeks post-operatively.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be followed for at least 16 weeks after your surgery, with measurements taken at 4, 8, and 16 weeks post-op.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Effect of BFR Rehab After Achilles Tendon Rupture
At a glance
Conditions
NCT06254794
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Houston Methodist Hospital
Houston, Texasstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- 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 (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 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.