Clinical trial NCT06356766: Investigation of Effectiveness of Telerehabilitation for Zone 2 Flexor Tendon Injuries of the Hand
Official title: Investigation of Effectiveness of Modified Duran Protocol Via Telerehabilitation After Zone 2 Flexor Tendon Injury Repair of the Hand
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Zone 2 Flexor Tendon Injuries of the Hand
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The treatment process following Zone 2 flexor tendon injuries, which are particularly controversial for hand surgery, is challenging. There are various rehabilitation methods for Zone 2 flexor tendon injuries, one of which is the Modified Duran Protocol. Disruptions in the physiotherapy process lead to joint contractures, tendon adhesions, and limitations in daily life activities for patients. Due to global issues such as socioeconomic factors, physical barriers, distance, and pandemics, patients who cannot actively participate in physiotherapy miss out on the rehabilitation process.

The aim of the present study is to investigate the effectiveness of the Modified Duran protocol applied through telerehabilitation following Zone 2 flexor tendon repair. Between April and October 2024, a total of 42 adults aged 18-55 who underwent Zone 2 flexor tendon repair at Istanbul University Istanbul Faculty of Medicine will be recruited, with 21 participants in face-to-face clinic group and 21 in telerehabilitation group. Rehabilitation process will be followed for 12 weeks. The telerehabilitation group will receive exercise training on the third day. After the first training session, patients will be discharged and called to the clinic once a week for dressing changes, monitoring, exercises and if necessary, revision of the protective splint. Patients will be contacted three times a week to implement the planned program using telerehabilitation.

The face-to-face rehabilitation group will receive face-to-face clinic rehabilitation three times a week under the supervision of a physiotherapist for the first 12 weeks.

Patients will be evaluated at the end of the 5th, 6th, and 12th weeks. Data collection tools will include a 'Sociodemographic Form', 'Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire', 'Visual Analog Scale (VAS)', 'Jamar Hand Dynamometer', and 'Goniometer (Joint Range of Motion)'.

SPSS (Statistical Package for the Social Sciences) Statistics will be used for the statistical analysis of all data, with a significance level of p \<0.05 considered significant in all assessments, and accepted as two-tailed.


Eligibility criteria: Inclusion Criteria:

* Individuals with isolated Zone 2 flexor digitorum profundus (FDP) and flexor digitorum superficialis (FDS) injuries,
* Repair performed within the first 72 hours post-injury,
* Individuals aged between 18 and 55 years,
* Patients willing to participate in the study,
* Ability to attend sessions regularly.

Exclusion Criteria:

* Fingers with concomitant fractures, digital nerve injuries, vascular injuries, or significant skin loss accompanying flexor tendon injuries,
* Bilateral flexor tendon injuries,
* Patients with replantation or revascularization,
* Flexor Pollicis Longus tendon injuries of the thumb due to differences in protocols applied and measurement of final outcomes,
* Patients unable to understand and perform postoperative exercises

Primary outcomes:
measure: Range of Motion
timeFrame: First week, 5th week, 6th week, 12th week
Secondary outcomes:
measure: DASH
timeFrame: First week, 5th week, 6th week, 12th week
measure: Pain of the affected hand
timeFrame: First week, 5th week, 6th week, 12th week
measure: Muscle Strength
timeFrame: 12th week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Faculty of Medicine
Study officials:
affiliation: Halic University
name: Seda Saka
role: STUDY_CHAIR
References: