CompletedNot Applicable

Comparison of Early Passive and Active Mobilization Protocols in Flexor Tendon Repair Rehabilitation of the Hand

Turkey (Türkiye)40 participantsStarted 2022-04-01

Plain-language summary

Many active and passive rehabilitation programs are applied in the rehabilitation processes after flexor tendon repair. There is no clear rehabilitation program accepted by the whole world. An accurate understanding of these injuries at the histological and biomechanical level is necessary to improve rehabilitation outcomes. Mechanical properties of tendons, such as their viscoelasticity, are affected by the increase in stiffness caused by the rupture, repair, and healing process. Previous studies have shown that the mechanical properties of a repaired tendon, such as stiffness, material properties and functionality of tendon tissue Shear-wave elastography can detect pathological changes in tendinopathy before they are visible on conventional Ultrasonography imaging. In addition, shear wave elastography allows the evaluation of quantitative measurements and is considered more objective because it provides reproducible results. Our aim in this study is to evaluate the changes in the mechanical properties of the hand flexor tendons repaired using shear wave elastography (SWE) during the rehabilitation process and natural process and their effect on functionality.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Forty patients aged 18-75 years who had flexor tendon injury and underwent primary surgical repair (within the first 10 days after injury) will be included in the study Exclusion Criteria: * Patients with a history of previous hand trauma, neurological or systemic disease affecting the hand, patients with a history of upper extremity surgery, concomitant extensor tendon injury, fracture and amputation will be excluded from the study.

Questions worth asking your doctor

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

tendon stiffness level tendon stiffness level tendon stiffness level tendon stiffness level tendon stiffness level

Timeframe: T0 : Patients were evaluated on postoperative 5-7 days.

tendon stiffness level tendon stiffness level tendon stiffness level tendon stiffness level tendon stiffness level

Timeframe: T1 : Patients were evaluated on postoperative 3 weeks.

tendon stiffness level tendon stiffness level tendon stiffness level tendon stiffness level tendon stiffness level

Timeframe: T2 : Patients were evaluated on postoperative 8 weeks.

tendon stiffness level tendon stiffness level tendon stiffness level tendon stiffness level tendon stiffness level

Timeframe: T3 : Patients were evaluated on postoperative 12 weeks.

Trial details

NCT IDNCT05598918

SponsorMarmara University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-01

View on ClinicalTrials.gov More Tendon Injuries trials