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| Name | Class |
|---|---|
| Cairo University | OTHER |
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The goal of this clinical trial is to learn whether adding blood flow restriction (BFR) training to a traditional rehabilitation protocol (TRP) can improve muscle strength, knee proprioception, range of motion, pain, and lower limb function after anterior cruciate ligament reconstruction (ACLR).
This study is conducted in male and female adults aged 18-35 years who underwent ACLR using a semitendinosus tendon autograft.
The main questions it aims to answer are:
Does adding BFR to a traditional rehabilitation protocol improve quadriceps and hamstring muscle strength after ACLR? Does adding BFR improve knee joint proprioception, range of motion, pain, and lower limb function after ACLR? Researchers compared a traditional rehabilitation protocol alone (control group) with the same protocol combined with blood flow restriction training (BFR group) to see if BFR provides superior improvements in postoperative outcomes.
Participants was: randomly assigned to either a traditional rehabilitation group or a BFR-assisted rehabilitation group Perform supervised rehabilitation exercises from the 2nd to the 12th postoperative week Undergo assessments of muscle strength, knee proprioception, range of motion, pain, and function Be evaluated 1 week before surgery and at 1.5 and 3 months after ACL reconstruction
Anterior cruciate ligament reconstruction (ACLR) is commonly followed by persistent quadriceps and hamstring weakness, reduced knee range of motion, impaired proprioception, pain, and limitations in lower limb function despite standard rehabilitation. Traditional postoperative rehabilitation protocols may not fully restore neuromuscular performance within the early months following surgery.
Blood flow restriction (BFR) training has emerged as a rehabilitation strategy that allows low-load exercise to produce strength gains comparable to high-load training by partially restricting arterial inflow and venous outflow during exercise. This approach may be particularly beneficial in the early postoperative phase after ACLR, when high mechanical loading is contraindicated.
This randomized controlled clinical trial investigates the effects of adding BFR training to a traditional rehabilitation protocol following ACL reconstruction. Participants are randomly allocated to either a traditional rehabilitation protocol alone or the same protocol combined with BFR applied to the operated limb during exercise sessions. Rehabilitation is initiated in the early postoperative period and continues for a standardized duration.
Clinical outcomes related to muscle performance, knee joint function, proprioceptive accuracy, range of motion, and pain are evaluated at multiple time points before and after surgery to examine short-term and mid-term recovery patterns. The study aims to determine whether the inclusion of BFR enhances functional recovery compared with conventional rehabilitation alone following ACLR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Rehabilitation Protocol Group | Active Comparator | Participants in this group received a standard postoperative rehabilitation program following anterior cruciate ligament reconstruction (ACLR) from the 2nd to the 12th postoperative week. |
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| Blood Flow Restriction (BFR) plus Traditional Rehabilitation Group | Experimental | Participants in this group received the same traditional postoperative rehabilitation protocol as the control group from the 2nd to the 12th postoperative week, with the addition of blood flow restriction (BFR) training applied during selected strengthening exercises. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| traditional rehabilitation protocol | Other | The traditional rehabilitation protocol includes progressive therapeutic exercises aimed at restoring: Quadriceps and hamstring muscle strength Knee joint range of motion Neuromuscular control and functional performance |
| Measure | Description | Time Frame |
|---|---|---|
| Quadriceps Muscle Strength | Assessed using a handheld dynamometer (HHD) Measured on the operated limb | preoperative baseline, 1.5 months post-operative, and 3 months post-operative |
| Hamstring Muscle Strength | Assessed using a handheld dynamometer (HHD) Measured on the operated limb | preoperative baseline, 1.5 months post-operative, and 3 months post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Joint Proprioception (Joint Position Sense) | Assessed using a digital inclinometer Evaluated as joint position sense accuracy | preoperative baseline, 1.5 months post-operative, and 3 months post-operative |
| Knee Joint Range of Motion (ROM) |
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Inclusion Criteria Male or female participants aged 18-35 years Undergoing primary unilateral anterior cruciate ligament reconstruction Reconstruction performed using semitendinosus tendon autograft Referred for postoperative rehabilitation by an orthopedic surgeon Medically cleared to participate in postoperative rehabilitation and exercise training Ability to understand and follow verbal instructions Willingness to participate and provide written informed consent Exclusion Criteria History of previous surgery on either knee Concomitant ligament injuries requiring surgical repair (e.g., PCL, MCL, LCL) Severe meniscal injury requiring repair or affecting rehabilitation progression Known cardiovascular, vascular, or thromboembolic disorders Peripheral vascular disease or conditions contraindicating blood flow restriction training Neurological disorders affecting lower limb function Uncontrolled systemic disease (e.g., uncontrolled diabetes or hypertension) Postoperative complications such as infection, deep vein thrombosis, or graft failure Inability to comply with the rehabilitation program or follow-up assessments
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| Name | Affiliation | Role |
|---|---|---|
| Maha Mohammed, A.Prof | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Cairo | Cairo Governorate | 11511 | Egypt | ||
| Physical Therapy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16339340 | Result | Abe T, Kearns CF, Sato Y. Muscle size and strength are increased following walk training with restricted venous blood flow from the leg muscle, Kaatsu-walk training. J Appl Physiol (1985). 2006 May;100(5):1460-6. doi: 10.1152/japplphysiol.01267.2005. Epub 2005 Dec 8. | |
| 18091686 | Result | Kramer LC, Denegar CR, Buckley WE, Hertel J. Factors associated with anterior cruciate ligament injury: history in female athletes. J Sports Med Phys Fitness. 2007 Dec;47(4):446-54. |
| Label | URL |
|---|---|
| After inclusion in the study, every patient signed an informed consent form , and then was randomly assigned to one of the two groups using a random generator | View source |
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Not applicable - the thesis does not describe a plan to share individual participant data with other researchers.
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| ID | Term |
|---|---|
| D000090003 | Blood Flow Restriction Therapy |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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Double-blinded randomized controlled trial
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patient and research assistant (the examiner of all patients) were blinded
| Blood Flow Restriction | Device | Blood flow restriction was applied to the proximal thigh of the operated limb using a specially designed sphygmomanometer cuff capable of partially restricting arterial inflow and venous outflow during exercise. BFR was used during low-load resistance exercises targeting the quadriceps and hamstring muscles, in accordance with postoperative safety guidelines. |
|
Flexion and extension measured using a digital goniometer
| preoperative baseline, 1.5 months post-operative, and 3 months post-operative |
| Knee Joint Pain | Assessed using the Visual Analog Scale (VAS) | preoperative baseline, 1.5 months post-operative, and 3 months post-operative |
| Lower Limb Function | Assessed using the Arabic version of the Lower Extremity Functional Scale (LEFS) | preoperative baseline, 1.5 months post-operative, and 3 months post-operative |
| Giza |
| 12613 |
| Egypt |
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| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |