Zone 2 Flexor Tendon Injuries of the HandNCT06356766
Investigation of Effectiveness of Telerehabilitation for Zone 2 Flexor Tendon Injuries of the Hand
A study testing Telerehabilitation and Face-to-face rehabilitation in people with Zone 2 Flexor Tendon Injuries of the Hand, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Zone 2 Flexor Tendon Injuries of the Hand
- What is being tested?
- Telerehabilitation and Face-to-face rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Apr 2024to 8 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Being tested
- Telerehabilitation, Face-to-face rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationOther
Modified Duran Protocol via Telerehabilitation
Face-to-face rehabilitationOther
Modified Duran Protocol
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation Group | Experimental | Modified Duran Protocol via telerehabilitation Receives: Other: Telerehabilitation |
| Face-to-face Rehabilitation Group | Active comparator | Modified Duran Protocol Receives: Other: Face-to-face rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion
Modified Strickland Formula
Measured: 6th week, 12th week
Secondary outcomes (3)
DASH
Disabilities of the Arm, Shoulder and Hand; min: 0 max: 100, lower scores indicate a lower level of disability
Measured: 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
Measured: First week, 6th week, 12th week
Muscle Strength
Jamar Hydraulic Hand Dynamometer
Measured: 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start8 Apr 2024
- Primary completion8 Nov 2024
- Study completion8 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zone 2 Flexor Tendon Injuries of the HandStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Merih Akpınar, Istanbul University
- Investigators
- Seda Saka, Study chair, Halic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06356766
- Sponsor's protocol ID
- 30.01.2024/009
- Status last verified
- Aug 2024
- First submitted
- 5 Apr 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Effectiveness of Modified Duran Protocol Via Telerehabilitation After Zone 2 Flexor Tendon Injury Repair of the Hand
- ClinicalTrials.gov ID
- NCT06356766
- Acronym / sponsor ID
- 30.01.2024/009
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 8 Nov 2024 (actual)
- Study completion
- 8 Jan 2025 (actual)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation Group | Experimental | Other: TelerehabilitationModified Duran Protocol via telerehabilitation |
| Face-to-face Rehabilitation Group | Active comparator | Other: Face-to-face rehabilitationModified Duran Protocol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelerehabilitationModified Duran Protocol via Telerehabilitation | Other | Telerehabilitation Group |
| Face-to-face rehabilitationModified Duran Protocol | Other | Face-to-face Rehabilitation Group |
Primary outcome
Range of Motion
Time frame: 6th week, 12th week
Modified Strickland Formula
3 secondary outcomes
DASH
Time frame: 6th week, 12th week
Pain of the affected hand
Time frame: First week, 6th week, 12th week
Muscle Strength
Time frame: 12th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Zone 2 Flexor Tendon Injuries of the Hand
Not yet recruiting
Effectiveness of Occupation-Based Exercise Program in Zone 2 Flexor Tendon Injuries
Tendon Injuries, Zone 2 Flexor Tendon Lacerations of the Hand
Active, not recruitingPhase 3
Zone 2 Flexor Tendon Repair With CoNextions TR Implant System
Tendon Injury - Hand
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seda Saka study chair
Halic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation and Face-to-face rehabilitation in people with Zone 2 Flexor Tendon Injuries of the Hand, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion (time frame: 6th week, 12th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.