- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT06356766
Undersökning av effektiviteten av telerehabilitering för zon 2 flexorsenskador i handen
Undersökning av effektiviteten av modifierat Duran-protokoll via telerehabilitering efter reparation av handens flexorsenskada i zon 2
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Istanbul, Turkiet (Türkiye)
- Istanbul Faculty of Medicine
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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 65 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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Telerehabilitation Group
Modified Duran Protocol via telerehabilitation |
Modified Duran Protocol via Telerehabilitation |
|
Aktiv komparator: Face-to-face Rehabilitation Group
Modified Duran Protocol |
Modified Duran Protocol |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Range of Motion
Tidsram: 6th week, 12th week
|
Modified Strickland Formula |
6th week, 12th week
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
DASH
Tidsram: 6th week, 12th week
|
Disabilities of the Arm, Shoulder and Hand; min: 0 max: 100, lower scores indicate a lower level of disability |
6th week, 12th week
|
|
Pain of the affected hand
Tidsram: First week, 6th week, 12th week
|
Visual Analogue Scale, min:0 cm/mm, max: 10 cm/100 mm, higher scores mean a higher degree of pain |
First week, 6th week, 12th week
|
|
Muscle Strength
Tidsram: 12th week
|
Jamar Hydraulic Hand Dynamometer |
12th week
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Seda Saka, Halic University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 30.01.2024/009
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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