Tendon InjuriesNCT07046416
Effectiveness of Occupation-Based Exercise Program in Zone 2 Flexor Tendon Injuries
A study testing Occupation-Based Exercise Program and Conventional therapy group in people with Tendon Injuries and Zone 2 Flexor Tendon Lacerations of the Hand, run by Berat Güngör at 1 site in Turkey (Türkiye).
Trial summary
Aim of the study is to evaluate the effects of a 4-week occupation-based exercise program given in addition to the conventional rehabilitation program on hand functions, range of motion, grip strength, pain and kinesiophobia in the post-operative rehabilitation of patients aged 18-65 years with zone 2 flexor tendon… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tendon Injuries, Zone 2 Flexor Tendon Lacerations of the Hand
- What is being tested?
- Occupation-Based Exercise Program and Conventional therapy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Between the ages of 18-65
- Flexor zone 2 injury
- At least 1 flexor digitorum superfisialis or flexor digitorum profundus tendon repair
- No visual and hearing impairment
- Have the cognitive function to coordinate and carry out simple commands
Who cannot join
- Concomitant flexor pollicis longus tendon injury
- Concomitant extensor tendon injury
- Accompanying fracture
- Associated median/ulnar/radial nerve injury
- Less than 50% partial flexor tendon injury
- Cognitive impairment resulting in an inability to understand and carry out simple commands
- Not being able to comply with the rehabilitation protocol to be applied after surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul Unıversity, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Istanbul
Berat Güngör, +905525101695, drberatgungor@gmail.com
About this study
Official title: Effectiveness of Occupation-Based Exercise Program Added to Conventional Rehabilitation Program on Hand Functions, Range of Motion, Grip Strength, Pain and Kinesiophobia in Zone 2 Flexor Tendon Injuries
Aim of the study is to evaluate the effects of a 4-week occupation-based exercise program given in addition to the conventional rehabilitation program on hand functions, range of motion, grip strength, pain and kinesiophobia in the post-operative rehabilitation of patients aged 18-65 years with zone 2 flexor tendon repair.
Expected results: To prove the effectiveness of occupation-based exercises in order to reduce the failure rates seen in the rehabilitation of zone 2 flexor tendon injuries, to increase patient compliance and motivation during the rehabilitation process, to improve functional outcomes by ensuring its inclusion in conventional treatment and to increase patient satisfaction.
- Being tested
- Occupation-Based Exercise Program, Conventional therapy group
- Medical subject headings
- Tendon Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupation-Based Exercise ProgramOther
In the occupation-based exercise program, while trying to improve the range of motion and muscle strength of the hand, it is aimed to successfully return to daily life activities. For this reason daily activities are used instead of memorized range movements. In this way, the occupation-based exercise program provides a physical recovery in patients with hand injuries, while providing positive improvements in parameters related to the mind and spirit. Patients' participation, motivation and compliance with the treatment are increased in the hand rehabilitation process, which can be challenging for patients.
In addition to the conventional treatment program, the study/experimental group, will be given occupation-based exercises for a total of 4 weeks between the 6th and 10th weeks postoperatively, 2 days a week with a physiotherapist and the other days with a home program.
Conventional therapy groupOther
Conventional group treatment will be according the early passive hand rehabilitation program. Conventional group will be followed with a cast-splint made by the surgical team for the first 4 weeks within the scope of the conventional treatment program. From the 4th week onwards, the duration of splint use is gradually reduced and is completely discontinued from the 6th week onwards. At the end of the 4th week, depending on the wound condition, contrast bath, scar massage, retrograde massage, active and passive flexion, active extension and tendon shifting exercises are applied as tolerated. After the 6th week, isolated block exercises and stretching exercises are added if there is contracture. Strengthening exercises are started from the 8th-10th week.
| Study group | Role | What they receive |
|---|---|---|
| Occupation-based exercise group | Experimental | Not described Receives: Other: Occupation-Based Exercise Program |
| Conventional therapy group | Active comparator | Not described Receives: Other: Conventional therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of The Arm, Shoulder and Hand Questionnaire (DASH)
In DASH Questionnaire a higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability. The score on both test ranges from 0 (no disability) to 100 (most severe disability).
Measured: Participants will be evaluated at 6th, 10th and 16th weeks postoperative.
Secondary outcomes (4)
Modified Strickland Classification
Range of motion of the fingers will be measured with a goniometer and results will classified according to Modified Strickland Classification
Measured: Participants will be evaluated at 6th, 10th and 16th weeks postoperatively.
Numerical Pain Rating Scale (NPRS)
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. Higher scores indicating greater pain intensity.
Measured: Participants will be evaluated at 6th, 10th and 16th weeks postoperatively.
Tampa Kinesiophobia Scale
The scale total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia.
Measured: Participants will be evaluated at 6th, 10th and 16th weeks postoperatively
Grip strentgh
Hand grip strength will be measured with a hand dynamometer and finger grip strength with a pinchmeter.
Measured: Participants will be evaluated at 6th, 10th and 16th weeks postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tendon InjuriesStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Berat Güngör
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University
- Responsible party
- Sponsor-investigator, Berat Güngör, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046416
- Sponsor's protocol ID
- 3005950
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Occupation-Based Exercise Program Added to Conventional Rehabilitation Program on Hand Functions, Range of Motion, Grip Strength, Pain and Kinesiophobia in Zone 2 Flexor Tendon Injuries
- ClinicalTrials.gov ID
- NCT07046416
- Acronym / sponsor ID
- 3005950
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Berat GüngörUniversity, hospital or other
- Collaborators
- Istanbul University
- Study start
- Jul 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Jul 2025 (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.
Aim of the study is to evaluate the effects of a 4-week occupation-based exercise program given in addition to the conventional rehabilitation program on hand functions, range of motion, grip strength, pain and kinesiophobia in the post-operative rehabilitation of patients aged 18-65 years with zone 2 flexor tendon repair.
Expected results: To prove the effectiveness of occupation-based exercises in order to reduce the failure rates seen in the rehabilitation of zone 2 flexor tendon injuries, to increase patient compliance and motivation during the rehabilitation process, to improve functional outcomes by ensuring its inclusion in conventional treatment and to increase patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occupation-based exercise group | Experimental | Other: Occupation-Based Exercise Program |
| Conventional therapy group | Active comparator | Other: Conventional therapy group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Between the ages of 18-65
- Flexor zone 2 injury
- At least 1 flexor digitorum superfisialis or flexor digitorum profundus tendon repair
- No visual and hearing impairment
- Have the cognitive function to coordinate and carry out simple commands
Key exclusion criteria (7 listed)
- Concomitant flexor pollicis longus tendon injury
- Concomitant extensor tendon injury
- Accompanying fracture
- Associated median/ulnar/radial nerve injury
- Less than 50% partial flexor tendon injury
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 |
|---|---|---|
| Occupation-Based Exercise ProgramIn the occupation-based exercise program, while trying to improve the range of motion and muscle strength of the hand, it is aimed to successfully return to daily life activities. For this reason daily activities are used instead of memorized range movements. In this way, the occupation-based exercise program provides a physical recovery in patients with hand injuries, while providing positive improvements in parameters related to the mind and spirit. Patients' participation, motivation and compliance with the treatment are increased in the hand rehabilitation process, which can be challenging for patients. In addition to the conventional treatment program, the study/experimental group, will be given occupation-based exercises for a total of 4 weeks between the 6th and 10th weeks postoperatively, 2 days a week with a physiotherapist and the other days with a home program. | Other | Occupation-based exercise group |
| Conventional therapy groupConventional group treatment will be according the early passive hand rehabilitation program. Conventional group will be followed with a cast-splint made by the surgical team for the first 4 weeks within the scope of the conventional treatment program. From the 4th week onwards, the duration of splint use is gradually reduced and is completely discontinued from the 6th week onwards. At the end of the 4th week, depending on the wound condition, contrast bath, scar massage, retrograde massage, active and passive flexion, active extension and tendon shifting exercises are applied as tolerated. After the 6th week, isolated block exercises and stretching exercises are added if there is contracture. Strengthening exercises are started from the 8th-10th week. | Other | Conventional therapy group |
Primary outcome
Disabilities of The Arm, Shoulder and Hand Questionnaire (DASH)
Time frame: Participants will be evaluated at 6th, 10th and 16th weeks postoperative.
In DASH Questionnaire a higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability. The score on both test ranges from 0 (no disability) to 100 (most severe disability).
4 secondary outcomes
Modified Strickland Classification
Time frame: Participants will be evaluated at 6th, 10th and 16th weeks postoperatively.
Numerical Pain Rating Scale (NPRS)
Time frame: Participants will be evaluated at 6th, 10th and 16th weeks postoperatively.
Tampa Kinesiophobia Scale
Time frame: Participants will be evaluated at 6th, 10th and 16th weeks postoperatively
Grip strentgh
Time frame: Participants will be evaluated at 6th, 10th and 16th weeks postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
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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.
Istanbul Unıversity, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Istanbul, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupation-Based Exercise Program and Conventional therapy group in people with Tendon Injuries and Zone 2 Flexor Tendon Lacerations of the Hand, run by Berat Güngör 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 7 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: opening soon, as of the sponsor's last update on 9 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disabilities of The Arm, Shoulder and Hand Questionnaire (DASH) (time frame: Participants will be evaluated at 6th, 10th and 16th weeks postoperative.). 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 9 Jul 2025.