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

Texas Tech University Health Sciences Center5 个研究点分布在 1 个国家目标入组 105 人开始时间: 2026年3月1日最近更新: 2026年3月17日

干预措施

试验速览

阶段: 不适用
状态: 招募中
发起方: Texas Tech University Health Sciences Center
入组人数: 105
试验地点: 5
主要终点: Muscle atrophy measurement - gastrocnemius

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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).

详细描述

Study Aims:

To evaluate the efficacy of Blood Flow Restriction (BFR) therapy compared to the current standard of care (SOC) in improving muscle atrophy, strength recovery, ankle functionality, and pain management in patients undergoing rehabilitation after ankle ligament reconstruction.

Objectives:

Evaluate Muscle Atrophy: To compare the extent of muscle recovery in the quadriceps and gastrocnemius muscles between patients receiving BFR therapy and those receiving the current standard of care. This will be done by comparing muscle circumference

Assess Fatigability Recovery: To determine whether BFR therapy accelerates the recovery of dynamic lower extremity fatigability more effectively than the current standard of care as measured by manual muscle testing (MMT)

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Single (Outcomes Assessor)

盲法说明

Following enrollment, subjects will be randomly assigned to either the intervention group (BFR therapy) or the control group (SOC). Patients will be randomized using sequentially numbered opaque sealed envelopes (SNOSE) with their treatment group and study ID number pre-assigned. These envelopes will contain the information regarding their randomization and will not be opened until after the patient is consented for the study.

The subject's treatment group will be communicated to their t-PT, after they have conducted the first visits' measurements. The t-PT will not perform any data collection for the subjects they treat and will and will perform physical therapy for those patients.

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•Major cardiac or connective tissue disorders (e.g., Ehlers-Danlos syndrome, Marfan syndrome).
•Autoimmune disorders.
•History of stroke or deep vein thrombosis (DVT).
•Bleeding or coagulation disorders.
•Congenital or developmental musculoskeletal disorders (e.g., cerebral palsy, Parkinson's disease).
•Pregnancy (current or planning to become pregnant in the next 4 months)
•Malignancy (cancer).
•Professional athletes.
•Workers compensation insurance status as worker's compensation often does not cover the necessary duration of physical therapy (minimum of 4 weeks).
•Be currently enrolled or have been enrolled in another interventional clinical research study within the past 30 days (at time of consent); or
•Be deemed unsuitable for inclusion in the study at the discretion of the Investigators
•Cognitively not able to consent or participate in research (dementia; severe developmental delay; language/communication limitations; brain injury; etc.)

研究组 & 干预措施

Standard of Care (SOC) group

No Intervention

standard course of physical therapy; no BFR

Blood flow restriction (BFR) group

Experimental

BFR device added during physical therapy

干预措施: blood flow restriction (Device)