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Not yet recruiting NCT05484141

The Effect of Blood Flow Restriction Method in Patellar Instability

No phase Interventional Patellar Abnormality

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rehabilitation with blood blow restriction, Rehabilitation without blood flow restriction.
Who it may be relevant to
Registry conditions: Patellar Abnormality. Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effect of Blood Flow Restriction Applied to the Extensor Muscles on Muscle Architecture and Strength, Knee Pain, and Functions in Minor Patellar Instability

Overview

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

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.

Interventions

  • Other Rehabilitation with blood blow restriction
    The rehabilitation program will be applied 2 days a week, for total of 8 weeks.
  • Other Rehabilitation without blood flow restriction
    The rehabilitation program will be applied 2 days a week, for total of 8 weeks.

Primary outcome measures

  • Assessment of Muscle Architecture and Hypertrophy [Time frame: 8 weeks]
Secondary outcome measures (4)
  • Assessment of Muscle Strength [Time frame: 8 weeks]
  • Assessment of Pain [Time frame: 8 weeks]
  • Evaluation of Functions [Time frame: 8 weeks]
  • Evaluation of Satisfaction and Change [Time frame: 8th week]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05484141 · PFI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗