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

Обзор

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).

Подробное описание

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)

Measure Functional Outcomes: To use the Foot and Ankle Disability Index (FADI) to evaluate improvements in ankle functionality and activities of daily living between the two treatment groups.

Monitor Pain Levels: To compare perceived pain levels during treatment and daily activities in patients undergoing BFR therapy versus those receiving standard care using a visual analog scale (VAS)

Analyze Cardiovascular Impact: To investigate changes in resting heart rate and blood pressure to identify any cardiovascular benefits associated with BFR therapy compared to the current standard of care

Study overview:

This study is designed as a randomized clinical trial to evaluate the efficacy of Blood Flow Restriction (BFR) therapy in postoperative rehabilitation following ankle ligament reconstruction.

Patients who have undergone ankle ligament reconstruction surgery performed by participating orthopedic surgeons will be randomized to either the treatment group (BFR therapy) or standard of care (SOC) group. Patients will then receive physical therapy (PT) managed by treatment physical therapists (t-PT). These therapists will perform BFR during the weekly PT sessions and provide the same at home exercises for participants in both groups. These physical therapists will not be part of the study team and will not collect study related data.

Patients in the treatment group will begin BFR therapy at least 28 days post-op (+7 days). The therapy will be performed on the affected limb, focusing on hip and knee strength, with ankle strengthening in plantarflexion and dorsiflexion in a seated position. Additional exercises include multi-joint hip and knee strengthening, such as straight leg raises, side-lying external rotation hip exercises (clam shells), short arc quads, long arc quads, hamstring curls, and hip bridges. Manual therapy including soft tissue mobilization and joint mobilization for ROM restoration will be provided as needed at the discretion of the physical therapist.

The SOC group will receive traditional physical therapy methods without BFR at least 28 days post-op (+ 7 days). The protocol will include similar exercises to those in the BFR group but without occlusion. Manual therapy including soft tissue mobilization and joint mobilization for ROM restoration will be provided as needed at the discretion of the t-PT.

Follow-up assessments and outcomes of interest will be collected by the study physical therapists (s-PT). s-PTs collecting study visit data will be blinded to the patient's treatment group. These measures include: muscle circumference (quadriceps and gastrocnemius), manual muscle testing (MMT) for fatigability recovery, Foot and Ankle Disability Index (FADI) for functional outcomes, pain levels using a visual analog scale (VAS), and cardiovascular measures (resting heart rate and blood pressure).

Assessments will be conducted at multiple time points for both the treatment and SOC groups:

Baseline: At initiation of physical therapy (28 days post-op + 7 days)) Visit 2: 63-70 days post-op Visit 3 (optional): At the end of the study (for patients continuing beyond the standard 6-weeks of physical therapy)

Вмешательства

• Устройство blood flow restriction
  The intervention group will receive the standard of care PT performed with BFR on affected limb. The intervention group will be treated with a BFR Smarttools SmartCuffs versions 3.0 or higher. During the baseline visit, the device will be placed over the affected limb's greater trochanter and inflated to 60% of their limb occlusion pressure. This will be titrated up to 80% over the first week to ensure subject comfort. During the remaining physical therapy sessions, patients will perform exerci

Первичные конечные точки

• Muscle atrophy measurement - gastrocnemius [Срок оценки: baseline/Visit 1 (28 days + 7 days post-op), Visit 2 (63-70 days post op), Visit 3 (optional - upon completion of PT)]
• Muscle atrophy measurement - quadriceps [Срок оценки: baseline/Visit 1 (28 days + 7 days post-op), Visit 2 (63-70 days post op), Visit 3 (optional - upon completion of PT)]
• Fatigability recovery using manual muscle testing (MMT) [Срок оценки: baseline/Visit 1 (28 days + 7 days post-op), Visit 2 (63-70 days post op), Visit 3 (optional - upon completion of PT)]
• Foot and Ankle Disability Index (FADI) [Срок оценки: baseline/Visit 1 (28 days + 7 days post-op), Visit 2 (63-70 days post op), Visit 3 (optional - upon completion of PT)]
• Pain Management - Visual analog scale [Срок оценки: baseline/Visit 1 (28 days + 7 days post-op), Visit 2 (63-70 days post op), Visit 3 (optional - upon completion of PT)]
• Cardiovascular impact - heart rate [Срок оценки: baseline/Visit 1 (28 days + 7 days post-op), Visit 2 (63-70 days post op), Visit 3 (optional - upon completion of PT)]
• Cardiovascular impact - blood pressure [Срок оценки: baseline/Visit 1 (28 days + 7 days post-op), Visit 2 (63-70 days post op), Visit 3 (optional - upon completion of PT)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 5 центров

• Physical Therapy Today (PTT) — Lubbock
• University Medical Center — Lubbock
• Northstar Surgery Center — Lubbock
• The Center for Orthopedic Surgery — Lubbock
• Texas Tech University Health Sciences Center — Lubbock

Идентификаторы

NCT: NCT07451210 · FY2024-335

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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