Effect of BFR Rehab After Achilles Tendon Rupture

Part of paid clinical trials in Houston, Texas.

Sponsor
The Methodist Hospital Research Institute
Study ID
NCT06254794
Status
Recruiting

Conditions

  • Achilles Tendon Rupture

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 13, 2018
Status verified
May 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
19 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Blood flow restriction group
    The study group will undergo normal Achilles tendon rupture reconstruction rehab modified by use of a tourniquet for blood flow restriction during selected exercises.
  • Other: Standard of Care (control) group
    The control group will undergo the normal Achilles tendon rupture reconstruction rehab protocol as determined by Drs. Varner and McCulloch.

Primary Outcome Measure

Muscle mass preservation [ Time Frame: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Houston Methodist HospitalHoustonTexas77030
Haley M Goble, MHA
713-441-3930
Patrick C McCulloch, MD (PRINCIPAL_INVESTIGATOR)

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