Investigation of Effectiveness of Telerehabilitation for Zone 2 Flexor Tendon Injuries of the Hand

NCT ID: NCT06356766

Last Updated: 2024-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-08

Study Completion Date

2025-05-08

Brief Summary

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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.

Detailed Description

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Conditions

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Zone 2 Flexor Tendon Injuries of the Hand

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Telerehabilitation Group

Modified Duran Protocol via telerehabilitation

Group Type EXPERIMENTAL

Telerehabilitation

Intervention Type OTHER

Modified Duran Protocol via Telerehabilitation

Face-to-face Rehabilitation Group

Modified Duran Protocol

Group Type ACTIVE_COMPARATOR

Face-to-face rehabilitation

Intervention Type OTHER

Modified Duran Protocol

Interventions

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Telerehabilitation

Modified Duran Protocol via Telerehabilitation

Intervention Type OTHER

Face-to-face rehabilitation

Modified Duran Protocol

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Fatma Merih Akpınar

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seda Saka

Role: STUDY_CHAIR

Halic University

Locations

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Istanbul Faculty of Medicine

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Sema Güven

Role: CONTACT

+905077531403

Fatma M Akpınar

Role: CONTACT

+905333558843

Facility Contacts

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Sema Guven

Role: primary

+905077531403

Merih Akpınar

Role: backup

+905333558843

Other Identifiers

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30.01.2024/009

Identifier Type: -

Identifier Source: org_study_id

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