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

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Minor Trial status changed: Unknown → Completed Show 4 more changesShow less
    • Study completion date changed from estimate of May 8, 2025 to Jan 8, 2025
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 2 of 3 entries
    • Site details revised
  2. Minor Changed Registry marked status Unknown; last known: Recruiting
  3. Notable Trial status: Not Yet Recruiting to Unknown
    • Study sites: 0 to 1
    • Start date changed from estimate of May 8, 2024 to Apr 8, 2024
    v4
  4. Notable Start date: Apr 8, 2024 to May 8, 2024
    • Primary completion date: Oct 8, 2024 to Nov 8, 2024
    • Study completion date: Apr 8, 2025 to May 8, 2025
    v3
  5. Minor Secondary endpoints: details revised at 2 of 3 entriesv2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 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.
Trial Details
NCT Number NCT06356766
Lead Sponsor Istanbul University
Conditions
(from sponsor)
Zone 2 Flexor Tendon Injuries of the Hand
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov