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The Effect of Blood Flow Restriction Method in Patellar Instability

ConditionPatellar Abnormality
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorBiruni University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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.),

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rehabilitation with blood blow restriction

    Other intervention

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

  • Rehabilitation without blood flow restriction

    Other intervention

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

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: With Blood Flow RestrictionExperimental treatment 1 intervention
Group B: Without Blood Flow RestrictionActive comparator 1 intervention

Trial outcomes

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.

Time frame
8 weeks

Secondary outcomes

1

Assessment of Muscle Strength

The concentric and eccentric strength of the knee extensor muscle (quadriceps) and its antagonist (hamstring), will be measured using the isokinetic dynamometer.

Time frame
8 weeks
2

Assessment of Pain

Visual Analogue Scale (VAS) will be used to evaluate the severity of pain in the knee of patients during activity, at rest, and at night. In the evaluation of pain intensity with VAS, the patient is asked to mark his pain above the 10-centimeter line defined as "0-no pain" and "10 unbearable pain" at both ends.

Time frame
8 weeks
3

Evaluation of Functions

The Tampa Kinesiophobia Scale (TKS) will be used to evaluate kinesiophobia. The lower extremity functional capacity of the subjects will be evaluated with the 1-minute sit-to-stand test, and the knee functions will be evaluated with the Lysholm Knee Scoring Scale and the Kujala Patellofemoral Joint Evaluation Scale, which are patient-answered scales that are recommended to be used in cases with patellar instability. In addition, fatigue determination after each application will be made with the Borg CR-10 Perceived Fatigue Scale. Scales will be filled by the face-to-face evaluation method.

Time frame
8 weeks
4

Evaluation of Satisfaction and Change

General satisfaction and the change in clinical status perceived by the participants will be evaluated with the 7 points Global Rating of Change Scale after the rehabilitation program. According to the scale, it is expressed as "-3: I am much worse, -2: I am worse, -1: I am a little worse, 0: No change, 1: I am a little better, 2: I am better, 3: I am much better".

Time frame
8th week

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Biruni University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: