Effects of Blood Flow Restriction With or Without Total Motion Release on Strength, Balance and Functional Disability in Postoperative ACL Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
研究概览
简要总结
The aim of this clinical trial is to compare the effectiveness of combined Blood Flow Restriction (BFR) and Total Motion Release (TMR) versus BFR alone in the restoration of muscular strength, balance and knee functionality in men and women aged 16 to 45 years who have undergone primary unilateral ACL reconstruction.
The major research questions that it seeks to address are:
Does the addition of TMR to a BFR protocol lead to significantly higher improvements in absolute quadriceps strength and subjective knee functioning as measured by IKDC scores? Does the combined protocol lead to better functional balance and symmetry in terms of the Single Leg Stance (SLS) test and Limb Symmetry Index (LSI)? The researchers will compare the BFR + TMR group to the BFR-only group to determine whether the integrated approach speeds up functional recovery and alleviates neuromuscular control deficits more effectively than strength-focused training alone.
Participant TasksParticipants will: Undergo 3 sessions/week of supervised rehabilitation over a 6 month period. Complete Blood Flow Restriction (BFR) training consisting of low-load exercises (mini squats and knee extensions) with an inflatable cuff placed around the proximal part of the thigh at 60-80% occlusion pressure. Should there be in the experimental group, Total Motion Release (TMR) exercises (e.g., trunk rotations and hip shifts) on the contralateral side (i.e. non-painful side) to correct movement asymmetries before the BFR training. Baseline, 6 weeks, 12 weeks, and 6 months of complete subjective self-assessments (IKDC forms) and objective physical tests (dynamometer strength testing and single-leg balance tests).
详细描述
Evaluate and compare the effectiveness of Blood Flow Restriction (BFR) therapy as a single intervention against a combined protocol of Blood Flow Restriction and Total Motion Release (BFR+TMR) in men and women aged 16-45 who had undergone primary unilateral ACL reconstruction. The study aimed to address persistent deficits in quadriceps strength, neuromuscular control, and movement symmetry that often remain after standard rehabilitation.
The main questions it aimed to answer were:
Did the integration of TMR-a method focused on movement symmetry-into a BFR protocol lead to superior improvements in absolute quadriceps strength and subjective knee function as measured by IKDC scores? Did the combined BFR+TMR protocol result in significantly better functional balance and limb symmetry compared to BFR training alone? Researchers compared a BFR+TMR experimental group to a BFR-only control group. The primary objective was to see if the combined approach, which targeted both peripheral muscle capacity (via BFR) and central neuromotor control (via TMR), provided a more holistic and accelerated recovery than targeting muscular adaptations alone.
Complete a 6-month rehabilitation program consisting of supervised sessions three times per week.
Perform Blood Flow Restriction (BFR) training on the affected limb using an inflatable cuff at 60-80% occlusion pressure during low-load resistance exercises such as mini squats and knee extensions.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 16-45 years.
- •Both male and female patients.
- •Underwent primary unilateral ACL reconstruction (hamstring or patellar tendon autograft).
- •2-4 weeks post-operative and cleared for supervised rehabilitation.
- •Willing and able to provide informed consent.
排除标准
- •Revision ACL surgery or multi-ligament injury.
- •Concomitant fracture or meniscal repair requiring restricted rehab.
- •History of DVT, vascular disease, uncontrolled hypertension, or cardiovascular disease.
- •Neurological disorders affecting lower limb strength or balance.
- •Contraindications to BFR (pregnancy, clotting disorders).
研究组 & 干预措施
BFR + TMR Group
Describe the Blood Flow Restruction and the Total Motion Release exercises
干预措施: Blood Flow Restriction (Device)
BFR + TMR Group
Describe the Blood Flow Restruction and the Total Motion Release exercises
干预措施: Total Motion Release (Procedure)
BFR Only Group
Describe only the blood flow restriction part.
干预措施: Blood Flow Restriction (Device)
研究者
Ali Muslim Raza
Co-Investigator
Green International University