NCT Number: NCT06565754
To study the effect of adding BFRT to strengthening exercises and compare it with strengthening exercises alone in improving, muscular strength, pain, function, joint position sense, and dynamic balance test (star excursion test). in patients with PFPS.
Trial opening soon.
Get Notified18 year–35 year
All sexes
Interventional
Not applicable
Giza, 12613, Egypt
abdelgalil A shaaban, PhD
CONTACT
abdelgalil A shaaban, PhD
PRINCIPAL_INVESTIGATOR
ahmed M khalil, PhD
PRINCIPAL_INVESTIGATOR
ahmed S helal, PhD
PRINCIPAL_INVESTIGATOR
enas F youssef, Professor
CONTACT
Background: Patellofemoral Pain Syndrome (PFPS) is a common condition characterized by anterior knee pain, particularly affecting individuals aged 15-30. It often involves lower limb muscle weakness, particularly in the quadriceps, which can exacerbate symptoms and affect functional performance. Blood Flow Restriction Training (BFRT) has shown promise in enhancing muscle strength and functional outcomes with reduced intensity compared to traditional high-intensity training.
Purpose: This study aims to compare the efficacy of combining BFRT with traditional strengthening exercises versus using strengthening exercises alone in improving muscular strength, pain, function, joint position sense, and dynamic balance in patients with PFPS.
Methods: A triple-blinded, randomized controlled trial was conducted at the Almenshawy General Hospital, Tanta, Egypt. Fifty patients with unilateral non-traumatic PFPS, aged 18-35, were randomly assigned to either a strengthening exercises group (SE Group) or a BFRT plus strengthening exercises group (BFRT Group). Both groups underwent a 6-week intervention with three sessions per week. Outcomes assessed included quadriceps and hip abductors strength, pain severity (Visual Analog Scale), functional status (Kujala Patellofemoral Score), joint position sense (measured by digital inclinometer), and dynamic balance (Star Excursion Balance Test).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Blood flow restriction training is an accessory to a variety of different exercise modes (e.g., resistance exercise, walking, cycling) has recently become a popular research topic. It involves the application of pressurized cuffs to the proximal portion of each lower extremity or upper extremity. It enhance blood pooling in the capillary beds of the limb muscles distal to the tourniquet or cuff.
The 3rd Generation SmartCuffs® pump (SmartCuffs® 3.0 PRO) is Personalized Pressure feature which allows for a fast, hassle-free personalized pressure calculation. With the built-in pressure sensor and on-board computer, it is calculate arterial occlusion pressure and set the optimal pressure for patient's body. There is no need for an external doppler probe or hand pump. This unit will do everything for patient. Smart Cuffs 3rd generation is FDA Approved Listed Class 1 device.
The automatized tourniquet (Smart Tools) contains a ring-shaped single- chamber
Quadriceps strengthening exercises are part of the treatment of PFPS, but the heavy resistance exercises may aggravate knee pain. Blood flow restriction training (BFRT) provides a low-load quadriceps strengthening method to treat PFPS (Giles et al., 2017).
Time frame: 6 weeks
Hand-Held Dynamometer (HHD). The Lafayette® HHD is a valid and reliable instrument of low cost and easy handling compared to the isokinetic dynamometer for assessment of muscle strength
Time frame: 6 weeks
The Visual Analog Scale is determined by measuring in millimeters from the left end of the line to the patient's mark. Participants will ask to determine the point at which pain represents the severity of pain maximum is 10 while lowest level of pain is zero
Time frame: 6 weeks
The 13 items on the scale are used to assess subjective symptoms and functional restrictions. A score can have a minimum of 0 points or a maximum of 100 points.
Time frame: 6 weeks
Digital Inclinometer for joint position sense assessment. Device (Digital Protractor, 82201b-00, INSPEC, China) The inclinometer is a valid and reliable method to assess the knee proprioception through JPS in open kinetic chain
Time frame: 6 weeks
Four strips of adhesive tape will need to be cut to a length of 6-8 feet each. Two pieces will be used to form a '+', with the other two being placed over top to form an 'x' so that a star shape is formed. It is important that all lines are separated from each other by a 45° angle. The goal of the Star Excursion Balance Test (SEBT) is to maintain single leg stance on one leg while reaching as far as possible with the contralateral leg.
Contact information is provided by the study sponsor or research team.
Cairo University
Other
Acronym: BFR
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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