Muscle Atrophy Clinical Trials

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Evaluating the Efficacy of Blood Flow Restriction Therapy in a Randomized Clinical Trial for Postoperative Rehabilitation Following Ankle Ligament Reconstruction

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this single blinded clinical trial is to investigate blood flow restriction (BFR) for rehabilitation of patients after ankle ligament reconstruction surgery. Outcome measures will be compared between the standard of care (SoC) and BFR groups at the end of the study intervention. Following standard surgical procedures, both groups will undergo physical therapy by a certified physical therapist for a minimum of 6 weeks. The SOC group will receive standard physical therapy without use of BFR. The BFR group will receive physical therapy with BFR. Outcome measures of interest will be taken at the start of physical therapy (time 0) and at the end of physical therapy (minimum of 6 weeks of PT) for both groups. Outcome measures of interest include: * muscle atrophy; * ankle function; * fatigability/manual muscle testing; * pain scores; * cardiovascular effects (heart rate, blood pressure).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Age 18-65 years.

• Post ankle ligament reconstruction surgery (medial or lateral, with or without ankle scope).

• Capability of paying for physical therapy or having insurance coverage for at least 6 weeks of therapy.

Locations
United States
Texas
Northstar Surgery Center
ACTIVE_NOT_RECRUITING
Lubbock
Physical Therapy Today (PTT)
ACTIVE_NOT_RECRUITING
Lubbock
Texas Tech University Health Sciences Center
RECRUITING
Lubbock
The Center for Orthopedic Surgery
RECRUITING
Lubbock
University Medical Center
ACTIVE_NOT_RECRUITING
Lubbock
Contact Information
Primary
Jenny Hudnall, MS BME
jennifer.hudnall@ttuhsc.edu
806-743-2260
Backup
Evan Hernandez, MBA
Evan.J.Hernandez@ttuhsc.edu
806-743-4600
Time Frame
Start Date: 2026-03-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 105
Treatments
No_intervention: Standard of Care (SOC) group
standard course of physical therapy; no BFR
Experimental: Blood flow restriction (BFR) group
BFR device added during physical therapy
Related Therapeutic Areas
Sponsors
Collaborators: Northstar Surgery Center, H2 Health (Physical Therapy Today), The Center for Orthopedic Surgery, UMC Health System
Leads: Texas Tech University Health Sciences Center

This content was sourced from clinicaltrials.gov