MedDataX Logo

The Effect of Blood Flow Restriction Method in Patellar Instability

NCT ID: NCT05484141

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The blood flow restriction method, the effects of which have been frequently investigated in the literature in recent years, can produce muscle hypertrophy with low-intensity load and can be easily tolerated through to low mechanical stress, seems to be an exercise approach that can be used in the recovery of strength in cases with minor patellar instability and can contribute to the recovery of functional capacity without delay.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patellar instability is defined as disruption of normal movement of the patella in the trochlear groove, symptomatic, medial-lateral displacement. Patients with patellar instability may not be able to tolerate high-intensity quadriceps exercises in the early period of strengthening programs due to pain symptoms, and therefore strength recovery may be delayed. However, it is important to restore muscle strength, especially vastus medialis obliquus strength, as early as possible in patellar instability. The blood flow restriction method, the effects of which have been frequently investigated in the literature in recent years, can produce muscle hypertrophy with low-intensity load and can be easily tolerated through to low mechanical stress, seems to be an exercise approach that can be used in the recovery of strength in cases with minor patellar instability and can contribute to the recovery of functional capacity without delay.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patellar Abnormality

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

With Blood Flow Restriction

Group Type EXPERIMENTAL

Rehabilitation with blood blow restriction

Intervention Type OTHER

The rehabilitation program will be applied 2 days a week, for total of 8 weeks.

Without Blood Flow Restriction

Group Type ACTIVE_COMPARATOR

Rehabilitation without blood flow restriction

Intervention Type OTHER

The rehabilitation program will be applied 2 days a week, for total of 8 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rehabilitation with blood blow restriction

The rehabilitation program will be applied 2 days a week, for total of 8 weeks.

Intervention Type OTHER

Rehabilitation without blood flow restriction

The rehabilitation program will be applied 2 days a week, for total of 8 weeks.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Being between the ages of 18-40 years,
* Volunteering to participate in the study,
* Having a complaint of anterior knee pain for at least 3 months,
* Having been diagnosed with unilateral minor patellar instability,
* Absence of any other ongoing clinical problems that interfere with exercise (will be questioned by the Physical Activity Readiness Questionnaire for All).

Exclusion Criteria

* History of one or more traumatic-atraumatic patella dislocations,
* Evidence of osteoarthritis on radiological imaging (≥ Kellgren-Lawrence Stage 2)
* Having at least one of the contraindications preventing the application of blood flow restrictive exercises (Smoking, previous venous thromboembolism, risk of peripheral vascular disease (ankle-brachial index \<0.9), coronary heart disease, hypertension, hemophilia, etc.),
* Previously diagnosed cardiovascular disease limiting effort capacity (Myocardial infarction, angina, exercise intolerance, etc.),
* Previously diagnosed neurological disorder or cognitive dysfunction (stroke, dementia, schizophrenia, etc.),
* Orthopedic lower extremity surgery in the last 1 year,
* Body mass index ≥ 30 kg/m2.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Biruni University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Begum Kara Kaya

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ayşe Zengin Alpözgen, PhD

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Begüm KARA KAYA, MSc

Role: CONTACT

Phone: +905355720021

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PFI

Identifier Type: -

Identifier Source: org_study_id