跳至主要内容
临床试验/NCT06437470
NCT06437470已完成不适用

Combined Effect of Blood Flow Restriction Technique and Conventional Physical Therapy After Anterior Cruciate Ligament Reconstruction: A Pilot Randomized Controlled Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
knee functional test

研究概览

简要总结

The purpose of this study will be to evaluate the effect of adding BFR (using 80% of LOP) to the conventional physical therapy program on knee function, functional test, balance, quadriceps and hamstrings muscles strength, thigh muscle girth and knee effusion in rehabilitation after ACLR.

详细描述

Anterior cruciate ligament (ACL) injury is one of the most common knee injuries especially in the age range 20 to 29 years. It is commonly seen during sport activities including jumping, pivoting or during contact with the other players (Khalil et al., 2023).

Quadriceps and hamstrings muscle weakness and atrophy are commonly seen after Anterior cruciate ligament reconstruction (ACLR) mainly due to weight bearing limitation in the early stage of rehabilitation (Barber-Westin and Noyes 2019 and Hughes et al., 2019). Recent rehabilitation protocols focused on range of motion (ROM) exercises and increased muscle activation in the early post-operative phase to minimize complications such as joint stiffness and muscle weakness (Myer et al., 2006 and Patterson et al., 2019a).

It is recommended by the American College of Sports Medicine to use 60% to 70% of one repetition maximum (1 RM) to increase muscle strength and 70% to 80% of 1 RM to increase muscle size. However, using these percentage of loads in the early post-operative phase after ACLR may not be applicable (Barber-Westin and Noyes 2019). Therefore, therapists considered it is necessary to find a safe exercise protocol designed to increase muscle strength and mass to be used in the early post-operative phase. One of these protocols is the blood flow restriction training (BFRT) (Patterson et al., 2019a).

The BFRT is a technique that restricts arterial and venous circulation in the working muscles during exercise (Scott et al., 2015). This technique uses a pneumatic tourniquet system that applies external pressure to the most proximal part of the arm or the thigh. Cuff inflation causes compression on the vascular structures under the cuff leading to occlusion of the venous return and restriction of the arterial blood flow to the distal part of the limb. This intentionally induced ischemic environment results in a state of hypoxia within the distal muscles (Manini and Clark 2009). In such environment, muscle strength and hypertrophy can be reached by smaller external loads such as 20% or 30% of 1RM (Loenneke et al., 2012a). This makes the BFRT applicable in the early post-operative phase of rehabilitation without stressing the knee joint, thus protecting the graft and minimizing the risk of increasing any associated injuries in cartilage or meniscus (Loenneke et al., 2012b and Arve et al., 2020).

The BFRT is beneficial for many groups such as geriatrics and those with degenerative joint diseases, ligamentous injury and inflammatory diseases (Hughes et al., 2017). Early BFRT research designs used general measures to calculate cuff pressures, such as setting pressure relative to systolic blood pressure, thigh circumference, or random pressures which is probably inaccurate especially with change in limb circumference or body position (Takano et al., 2005 and Loenneke et al., 2015). A study performed by (Khalil et al., 2023) used the portable doppler ultrasound device to calculate limb occlusion pressure (LOP) of dorsalis pedis artery while manually inflating the restriction cuff. This procedure is operator dependent and may lead to some errors, especially in determining the exact location of the artery.

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

a single-blinded design, ensuring that the research assistant (who serves as the examiner for all patients) and the statistician are blinded to the treatment group.

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Aged from 18-35 years.
  • Underwent an ACLR semitendinosus autograft one-week post-operative
  • Willingness to participate in the intervention and subsequent assessment.
  • BMI from 18.5 to 29.9 kg/m2.

排除标准

  • Insecure graft fixation (due to bone quality, suspension).
  • Active infection.
  • Postsurgical excess knee swelling that may limit exercise performance.
  • ACLR using bone tendon bone (BTB) graft.
  • Any cardiovascular disease such as hypertension.
  • Any lower limb trauma.
  • Hip and ankle pathology.
  • BMI more than 30 kg/m2

研究组 & 干预措施

conventional physical therapy program

Sham Comparator

participants will receive the conventional physical therapy program while using non-inflated cuff as a sham treatment during exercising.

干预措施: blood flow restriction technique (Other)

blood flow restriction combined to conventional physical therapy program

Experimental

participants will receive the conventional physical therapy program with the use of BFR cuff which will be inflated to reach 80% of limb occlusive pressure

干预措施: blood flow restriction technique (Other)

结局指标

主要结局

knee functional test

时间窗: after 3 months of intervention

will be assessed by the single leg hop test

balance

时间窗: after 3 months of intervention

will be assessed by the Y balance test for the lower quarter

quadriceps and hamstring muscles strength

时间窗: after 3 months of intervention

will be assessed by the hand held dynamometer

knee function

时间窗: after 3 months of intervention

will be assessed by the Arabic version of the knee outcome survey-activities for daily living scale. It encompasses six questions addressing restrictions in daily activities caused by symptoms like pain, swelling, and instability, and eight questions evaluating difficulties in functional tasks such as walking, stair climbing, and sitting or standing up from a chair. Each question is rated on a 6-point Likert scale. Scores range from 0 to 70, with higher scores indicating better functional capacity.

次要结局

  • Thigh muscle girth(baseline then 3 months after intervention)
  • Knee effusion(baseline then 3 months after intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mostafa Ahmed Ali Abed

Assistant Lecturer of Physical Therapy for Musculoskeletal System Disorders and its Surgery, Faculty of Physical Therapy, Cairo University

Cairo University

研究点 (2)

Loading locations...

相似试验