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

Investigation of Effectiveness of Modified Duran Protocol Via Telerehabilitation After Zone 2 Flexor Tendon Injury Repair of the Hand

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.

Study Overview

• Status: Recruiting
• Conditions: Zone 2 Flexor Tendon Injuries of the Hand
• Intervention / Treatment: Other: Telerehabilitation; Other: Face-to-face rehabilitation

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sema Guven; Phone Number: +905077531403; Email: fzt.semaguven@gmail.com
• Study Contact Backup: Name: Fatma M Akpınar; Phone Number: +905333558843; Email: merihcaliskan@gmail.com

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Istanbul Faculty of Medicine
    • Contact: Sema Guven; Phone Number: +905077531403; Email: fzt.semaguven@gmail.com
    • Contact: Merih Akpınar; Phone Number: +905333558843; Email: merihcaliskan@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telerehabilitation Group; Modified Duran Protocol via telerehabilitation	Other: Telerehabilitation; Modified Duran Protocol via Telerehabilitation
Active Comparator: Face-to-face Rehabilitation Group; Modified Duran Protocol	Other: Face-to-face rehabilitation; Modified Duran Protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of Motion	Modified Strickland Formula	First week, 5th week, 6th week, 12th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Strength	Jamar Hydraulic Hand Dynamometer	12th week
DASH	Disabilities of the Arm, Shoulder and Hand; min: 0 max: 100, lower scores indicate a lower level of disability	First week, 5th week, 6th week, 12th week
Pain of the affected hand	Visual Analogue Scale, min:0 cm/mm, max: 10 cm/100 mm, higher scores mean a higher degree of pain	First week, 5th week, 6th week, 12th week

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Study Chair: Seda Saka, Halic University

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2024
• Primary Completion (Estimated): November 8, 2024
• Study Completion (Estimated): May 8, 2025

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: April 5, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 16, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Tendon Injuries
• Other Study ID Numbers: 30.01.2024/009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No