Blood Flow Restriction in ACL Reconstruction Rehabilitation: A Double-Blinded RCT

NCT07406763 | Completed DMC

• 1 other identifier: P.T.REC/012/003141
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Blood Flow Restriction Therapy; Anterior Cruciate Ligament (ACL)

Keywords

ACLR; BFRT

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Knee Joint Proprioception (Joint Position Sense)

  preoperative baseline, 1.5 months post-operative, and 3 months post-operative

• Knee Joint Range of Motion (ROM)

  preoperative baseline, 1.5 months post-operative, and 3 months post-operative

• Knee Joint Pain

  preoperative baseline, 1.5 months post-operative, and 3 months post-operative

• Lower Limb Function

  preoperative baseline, 1.5 months post-operative, and 3 months post-operative

Study Arms (2)

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.

Other: traditional rehabilitation protocol

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.

Other: traditional rehabilitation protocol; Device: Blood Flow Restriction

Interventions

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

Blood Flow Restriction (BFR) plus Traditional Rehabilitation Group; Traditional Rehabilitation Protocol Group

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.

Blood Flow Restriction (BFR) plus Traditional Rehabilitation Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Ahmed Mohamed Mahmoud Abdelaziz Khalil: lead
• Cairo University: collaborator

Study Sites (2)

Cairo University

Cairo, Cairo Governorate, 11511, Egypt

Location

Physical Therapy

Giza, 12613, Egypt

Location

Related Publications (25)

• 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.

  PMID: 16339340 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.

  PMID: 18091686 RESULT

• Elwood PC, Pickering J, Bayer A, Gallacher JE. Vascular disease and cognitive function in older men in the Caerphilly cohort. Age Ageing. 2002 Jan;31(1):43-8. doi: 10.1093/ageing/31.1.43.

  PMID: 11850307 RESULT

• Yip T, Wang Y, Mootoo C, Mirpuri S. Moderating the association between discrimination and adjustment: A meta-analysis of ethnic/racial identity. Dev Psychol. 2019 Jun;55(6):1274-1298. doi: 10.1037/dev0000708. Epub 2019 Mar 25.

  PMID: 30907605 RESULT

• Pletch A, Morcuende J, Barriga H, Segura J, Salas A. Photovoice and Clubfoot: Using a Participatory Research Method to Study Caregiver Adherence to the Ponseti Method in Peru. Iowa Orthop J. 2015;35:160-8.

  PMID: 26361460 RESULT

• Lepley AS, Grooms DR, Burland JP, Davi SM, Kinsella-Shaw JM, Lepley LK. Quadriceps muscle function following anterior cruciate ligament reconstruction: systemic differences in neural and morphological characteristics. Exp Brain Res. 2019 May;237(5):1267-1278. doi: 10.1007/s00221-019-05499-x. Epub 2019 Mar 9.

  PMID: 30852644 RESULT

• Herring AA, Stone MB, Frenkel O, Chipman A, Nagdev AD. The ultrasound-guided superficial cervical plexus block for anesthesia and analgesia in emergency care settings. Am J Emerg Med. 2012 Sep;30(7):1263-7. doi: 10.1016/j.ajem.2011.06.023. Epub 2011 Oct 24.

  PMID: 22030184 RESULT

• Laurentino GC, Loenneke JP, Mouser JG, Buckner SL, Counts BR, Dankel SJ, Jessee MB, Mattocks KT, Iared W, Tavares LD, Teixeira EL, Tricoli V. Validity of the Handheld Doppler to Determine Lower-Limb Blood Flow Restriction Pressure for Exercise Protocols. J Strength Cond Res. 2020 Sep;34(9):2693-2696. doi: 10.1519/JSC.0000000000002665.

  PMID: 29912080 RESULT

• Schlag J, Pouget A, Sadeghpour S, Schlag-Rey M. Interactions between natural and electrically evoked saccades. III. Is the nonstationarity the result of an integrator not instantaneously reset? J Neurophysiol. 1998 Feb;79(2):903-10. doi: 10.1152/jn.1998.79.2.903.

  PMID: 9463451 RESULT

• Felszeghy S, Modis L, Nemeth P, Nagy G, Zelles T, Agre P, Laurikkala J, Fejerskov O, Thesleff I, Nielsen S. Expression of aquaporin isoforms during human and mouse tooth development. Arch Oral Biol. 2004 Apr;49(4):247-57. doi: 10.1016/j.archoralbio.2003.09.011.

  PMID: 15003543 RESULT

• Krych AJ, Pitts RT, Dajani KA, Stuart MJ, Levy BA, Dahm DL. Surgical repair of meniscal tears with concomitant anterior cruciate ligament reconstruction in patients 18 years and younger. Am J Sports Med. 2010 May;38(5):976-82. doi: 10.1177/0363546509354055. Epub 2010 Mar 18.

  PMID: 20299545 RESULT

• Liu A, Xue GH, Sun M, Shao HF, Ma CY, Gao Q, Gou ZR, Yan SG, Liu YM, He Y. 3D Printing Surgical Implants at the clinic: A Experimental Study on Anterior Cruciate Ligament Reconstruction. Sci Rep. 2016 Feb 15;6:21704. doi: 10.1038/srep21704.

  PMID: 26875826 RESULT

• Lindstrom M, Strandberg S, Wredmark T, Fellander-Tsai L, Henriksson M. Functional and muscle morphometric effects of ACL reconstruction. A prospective CT study with 1 year follow-up. Scand J Med Sci Sports. 2013 Aug;23(4):431-42. doi: 10.1111/j.1600-0838.2011.01417.x. Epub 2011 Nov 23.

  PMID: 22107159 RESULT

• Loenneke JP, Abe T, Wilson JM, Thiebaud RS, Fahs CA, Rossow LM, Bemben MG. Blood flow restriction: an evidence based progressive model (Review). Acta Physiol Hung. 2012 Sep;99(3):235-50. doi: 10.1556/APhysiol.99.2012.3.1.

  PMID: 22982712 RESULT

• Malinzak RA, Colby SM, Kirkendall DT, Yu B, Garrett WE. A comparison of knee joint motion patterns between men and women in selected athletic tasks. Clin Biomech (Bristol). 2001 Jun;16(5):438-45. doi: 10.1016/s0268-0033(01)00019-5.

  PMID: 11390052 RESULT

• Marcon M, Ciritsis B, Laux C, Nanz D, Nguyen-Kim TD, Fischer MA, Andreisek G, Ulbrich EJ. Cross-sectional area measurements versus volumetric assessment of the quadriceps femoris muscle in patients with anterior cruciate ligament reconstructions. Eur Radiol. 2015 Feb;25(2):290-8. doi: 10.1007/s00330-014-3424-2. Epub 2014 Oct 31.

  PMID: 25358592 RESULT

• May AK, Brandner CR, Warmington SA. Hemodynamic responses are reduced with aerobic compared with resistance blood flow restriction exercise. Physiol Rep. 2017 Feb;5(3):e13142. doi: 10.14814/phy2.13142.

  PMID: 28183863 RESULT

• McHugh MP, Tyler TF, Gleim GW, Nicholas SJ. Preoperative indicators of motion loss and weakness following anterior cruciate ligament reconstruction. J Orthop Sports Phys Ther. 1998 Jun;27(6):407-11. doi: 10.2519/jospt.1998.27.6.407.

  PMID: 9617726 RESULT

• Minniti MC, Statkevich AP, Kelly RL, Rigsby VP, Exline MM, Rhon DI, Clewley D. The Safety of Blood Flow Restriction Training as a Therapeutic Intervention for Patients With Musculoskeletal Disorders: A Systematic Review. Am J Sports Med. 2020 Jun;48(7):1773-1785. doi: 10.1177/0363546519882652. Epub 2019 Nov 11.

  PMID: 31710505 RESULT

• Ozaki H, Sakamaki M, Yasuda T, Fujita S, Ogasawara R, Sugaya M, Nakajima T, Abe T. Increases in thigh muscle volume and strength by walk training with leg blood flow reduction in older participants. J Gerontol A Biol Sci Med Sci. 2011 Mar;66(3):257-63. doi: 10.1093/gerona/glq182. Epub 2010 Oct 25.

  PMID: 20974731 RESULT

• Relph N, Herrington L, Tyson S. The effects of ACL injury on knee proprioception: a meta-analysis. Physiotherapy. 2014 Sep;100(3):187-95. doi: 10.1016/j.physio.2013.11.002. Epub 2013 Dec 4.

  PMID: 24690442 RESULT

• Zou W, Cheng H, Li S, Yue X, Xue Y, Chen S, Kang L. Polymodal Responses in C. elegans Phasmid Neurons Rely on Multiple Intracellular and Intercellular Signaling Pathways. Sci Rep. 2017 Feb 14;7:42295. doi: 10.1038/srep42295.

  PMID: 28195191 RESULT

• van der Made AD, Paget LDA, Altink JN, Reurink G, Six WR, Tol JL, Kerkhoffs GM. Assessment of Isometric Knee Flexor Strength Using Hand-Held Dynamometry in High-Level Rugby Players Is Intertester Reliable. Clin J Sport Med. 2021 Sep 1;31(5):e271-e276. doi: 10.1097/JSM.0000000000000793.

  PMID: 31842051 RESULT

• Suga T, Okita K, Takada S, Omokawa M, Kadoguchi T, Yokota T, Hirabayashi K, Takahashi M, Morita N, Horiuchi M, Kinugawa S, Tsutsui H. Effect of multiple set on intramuscular metabolic stress during low-intensity resistance exercise with blood flow restriction. Eur J Appl Physiol. 2012 Nov;112(11):3915-20. doi: 10.1007/s00421-012-2377-x. Epub 2012 Mar 14.

  PMID: 22415101 RESULT

• Abe T, Fujita S, Nakajima T, Sakamaki M, Ozaki H, Ogasawara R, Sugaya M, Kudo M, Kurano M, Yasuda T, Sato Y, Ohshima H, Mukai C, Ishii N. Effects of Low-Intensity Cycle Training with Restricted Leg Blood Flow on Thigh Muscle Volume and VO2MAX in Young Men. J Sports Sci Med. 2010 Sep 1;9(3):452-8. eCollection 2010.

  PMID: 24149640 RESULT

Related Links

• 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

MeSH Terms

Interventions

Blood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Maha Mohammed, A.Prof

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: patient and research assistant (the examiner of all patients) were blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: doctor

Model Details: Double-blinded randomized controlled trial

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 12, 2026
• Study Start: February 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2022
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)