NCT06254794

Effect of BFR Rehab After Achilles Tendon Rupture

Effect of Blood Flow Restriction (BFR) Rehabilitation After Achilles Tendon Rupture Reconstruction

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (estimated)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Achilles Tendon Rupture

Interventions

Type	Name	Description
DEVICE	Blood flow restriction with Delfi Personalized Tourniquet System (PTS)	Standard of care physical therapy exercises with the use of the Delfi PTS cuff
OTHER	Physical therapy	Standard of care physical therapy exercises

Timeline

• Start date: 2018-11-13
• Primary completion: 2026-12-01
• Completion: 2028-12-01
• First posted: 2024-02-12
• Last updated: 2025-05-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study