The Effect of Blood Flow Restriction Method in Patellar Instability

NCT05484141 | Not Yet Recruiting

• 1 other identifier: PFI
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Patellar Abnormality

Outcome Measures

Primary Outcomes (1)

• Assessment of Muscle Architecture and Hypertrophy

  A portable, diagnostic B-mode ultrasound device with a linear probe will be used to evaluate the quadriceps muscle architecture. Cross-sectional areas, muscle thicknesses, fascicle lengths, and pennation angles, the architectural parameters of both thigh muscles, will be assessed by ultrasound. All assessments will be calculated as millimeters.

  8 weeks

Secondary Outcomes (4)

• Assessment of Muscle Strength

  8 weeks

• Assessment of Pain

  8 weeks

• Evaluation of Functions

  8 weeks

• Evaluation of Satisfaction and Change

  8th week

Study Arms (2)

With Blood Flow Restriction

EXPERIMENTAL

Other: Rehabilitation with blood blow restriction

Without Blood Flow Restriction

ACTIVE COMPARATOR

Other: Rehabilitation without blood flow restriction

Interventions

Rehabilitation without blood flow restriction OTHER

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

Without Blood Flow Restriction

Rehabilitation with blood blow restriction OTHER

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

With Blood Flow Restriction

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biruni University: lead

MeSH Terms

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ayşe Zengin Alpözgen, PhD

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Central Study Contacts

Begüm KARA KAYA, MSc

CONTACT

+905355720021; bkara@biruni.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: August 2, 2022
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share