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

NCT06356766 | Recruiting

• 1 other identifier: 30.01.2024/009
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Zone 2 Flexor Tendon Injuries of the Hand

Outcome Measures

Primary Outcomes (1)

• Range of Motion

  Modified Strickland Formula

  First week, 5th week, 6th week, 12th week

Secondary Outcomes (3)

• DASH

  First week, 5th week, 6th week, 12th week

• Pain of the affected hand

  First week, 5th week, 6th week, 12th week

• Muscle Strength

  12th week

Study Arms (2)

Telerehabilitation Group

EXPERIMENTAL

Modified Duran Protocol via telerehabilitation

Other: Telerehabilitation

Face-to-face Rehabilitation Group

ACTIVE COMPARATOR

Modified Duran Protocol

Other: Face-to-face rehabilitation

Interventions

Telerehabilitation OTHER

Modified Duran Protocol via Telerehabilitation

Telerehabilitation Group

Face-to-face rehabilitation OTHER

Modified Duran Protocol

Face-to-face Rehabilitation Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul Faculty of Medicine

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Telerehabilitation

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Seda Saka

  Halic University

  STUDY CHAIR

Central Study Contacts

Sema Güven

CONTACT

+905077531403; fzt.semaguven@gmail.com

Fatma M Akpınar

CONTACT

+905333558843; merihcaliskan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 10, 2024
• Study Start: April 8, 2024
• Primary Completion: November 8, 2024
• Study Completion: May 8, 2025
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)