Flexor Tendon Injuries of the Hand (Zones II-V)NCT07201740
The Effectiveness of Leap Motion-Based Virtual Reality in the Rehabilitation of Flexor Tendon Injuries of the Hand
A study testing Leap Motion-based Virtual Reality Therapy and Active Comparator - Routine Rehabilitation Only in people with Flexor Tendon Injuries of the Hand (Zones II-V), run by Kocaeli University.
Trial summary
This randomized controlled clinical trial aims to evaluate the effectiveness of a Leap Motion-based virtual reality rehabilitation program in patients who underwent surgical repair for flexor tendon injuries of the hand (zones II-V). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Flexor Tendon Injuries of the Hand (Zones II-V)
- What is being tested?
- Leap Motion-based Virtual Reality Therapy and Active Comparator - Routine Rehabilitation Only
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Feb 2026
- 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
- Age between 18 and 65 years
- Flexor tendon injury of the hand (zones II-V)
- Early surgical repair completed
- At least 5 weeks postoperative
- Eligible for routine hand rehabilitation program
Who cannot join
- Communication problems
- Cognitive impairment
- Additional musculoskeletal, neurological, or rheumatological diseases affecting upper extremity function
- Multiple trauma cases
About this study
This randomized controlled clinical trial aims to evaluate the effectiveness of a Leap Motion-based virtual reality rehabilitation program in patients who underwent surgical repair for flexor tendon injuries of the hand (zones II-V). A total of 66 participants, aged 18-65 years and at least 5 weeks postoperative, will be randomly assigned to two groups: the intervention group will receive routine hand rehabilitation plus Leap Motion-based virtual reality therapy for 20 minutes per day, 5 days per week, for 4 weeks; while the control group will continue routine hand rehabilitation only. Outcomes will include joint range of motion measured with a goniometer, pain intensity assessed with a Visual Analog Scale (VAS), grip strength measured with a Jamar dynamometer, and functional outcomes assessed using the QuickDASH questionnaire. The primary endpoint is the change in range of motion, grip strength, and QuickDASH score from baseline to post-treatment. Secondary endpoints include changes in upper extremity function and pain tolerance. All interventions will be delivered under therapist supervision. This study is expected to provide evidence on whether integrating Leap Motion-based virtual reality into conventional rehabilitation improves clinical outcomes after flexor tendon repair.
- Being tested
- Leap Motion-based Virtual Reality Therapy, Active Comparator - Routine Rehabilitation Only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leap Motion-based Virtual Reality TherapyDevice
Arm 1 - Experimental (Leap Motion + Routine Hand Rehabilitation)
Intervention Description: Participants will receive standard postoperative hand rehabilitation plus Leap Motion-based virtual reality training. The VR training will be performed for 20 minutes per day, 5 days per week, for 4 weeks, in addition to routine rehabilitation. The Leap Motion Controller tracks hand and finger movements without physical contact and allows participants to practice functional tasks and grasp patterns in a virtual environment.
Arm 2 - Active Comparator (Routine Hand Rehabilitation Only)
Intervention Description: Participants will receive only routine postoperative hand rehabilitation, performed for 1 hour per day, 5 days per week, for 4 weeks, supervised by a therapist.
Active Comparator - Routine Rehabilitation OnlyOther
Participants will receive only routine postoperative hand rehabilitation, performed for 1 hour per day, 5 days per week, for 4 weeks, supervised by a therapist.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Arm Title: Leap Motion + Routine Hand Rehabilitation
Description: Participants receive standard postoperative hand rehabilitation plus Leap Motion-based virtual reality training for 20 minutes/day, 5 days/week, for 4 weeks.
Intervention Type: Device (Leap Motion-based virtual reality therapy)
Other Intervention: Behavioral (Routine hand rehabilitation program) Receives: Device: Leap Motion-based Virtual Reality Therapy |
| Active Comparator (Control) | Active comparator | Arm 2 - Active Comparator (Control)
Arm Title: Routine Hand Rehabilitation Only
Description: Participants receive only routine postoperative hand rehabilitation for 1 hour/day, 5 days/week, for 4 weeks.
Intervention Type: Behavioral (Routine hand rehabilitation program) Receives: Other: Active Comparator - Routine Rehabilitation Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper limb disability/function
Functional disability of the upper limb assessed with the Quick Disabilities of the Arm, Shoulder, and Hand questionnaire. In the Q-DASH, a higher score indicates worse outcome, while a lower score indicates better outcome.
Measured: Baseline and 4 weeks post-treatment
Joint range of motion (ROM)
Assessed with a manual goniometer. Comparison between baseline and after 4 weeks of treatment. A higher ROM indicates a better clinical condition.
Measured: Baseline and 4 weeks post-treatment
Grip strength
Assessed using a Jamar hand dynamometer.
Measured: Baseline and 4 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flexor Tendon Injuries of the Hand (Zones II-V)Studies 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
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serkan Kablanoğlu, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201740
- Sponsor's protocol ID
- KC-KABLANOGLU-001
- Status last verified
- Aug 2025
- First submitted
- 26 Aug 2025
- Last updated
- 1 Oct 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 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Leap Motion-Based Virtual Reality in the Rehabilitation of Flexor Tendon Injuries of the Hand
- ClinicalTrials.gov ID
- NCT07201740
- Acronym / sponsor ID
- KC-KABLANOGLU-001
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 1 Oct 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.
This randomized controlled clinical trial aims to evaluate the effectiveness of a Leap Motion-based virtual reality rehabilitation program in patients who underwent surgical repair for flexor tendon injuries of the hand (zones II-V). A total of 66 participants, aged 18-65 years and at least 5 weeks postoperative, will be randomly assigned to two groups: the intervention group will receive routine hand rehabilitation plus Leap Motion-based virtual reality therapy for 20 minutes per day, 5 days per week, for 4 weeks; while the control group will continue routine hand rehabilitation only. Outcomes will include joint range of motion measured with a goniometer, pain intensity assessed with a Visual Analog Scale (VAS), grip strength measured with a Jamar dynamometer, and functional outcomes assessed using the QuickDASH questionnaire. The primary endpoint is the change in range of motion, grip strength, and QuickDASH score from baseline to post-treatment. Secondary endpoints include changes in upper extremity function and pain tolerance. All interventions will be delivered under therapist supervision. This study is expected to provide evidence on whether integrating Leap Motion-based virtual reality into conventional rehabilitation improves clinical outcomes after flexor tendon repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Leap Motion-based Virtual Reality TherapyArm Title: Leap Motion + Routine Hand Rehabilitation Description: Participants receive standard postoperative hand rehabilitation plus Leap Motion-based virtual reality training for 20 minutes/day, 5 days/week, for 4 weeks. Intervention Type: Device (Leap Motion-based virtual reality therapy) Other Intervention: Behavioral (Routine hand rehabilitation program) |
| Active Comparator (Control) | Active comparator | Other: Active Comparator - Routine Rehabilitation OnlyArm 2 - Active Comparator (Control) Arm Title: Routine Hand Rehabilitation Only Description: Participants receive only routine postoperative hand rehabilitation for 1 hour/day, 5 days/week, for 4 weeks. Intervention Type: Behavioral (Routine hand rehabilitation program) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 65 years
- Flexor tendon injury of the hand (zones II-V)
- Early surgical repair completed
- At least 5 weeks postoperative
- Eligible for routine hand rehabilitation program
Key exclusion criteria (4 listed)
- Communication problems
- Cognitive impairment
- Additional musculoskeletal, neurological, or rheumatological diseases affecting upper extremity function
- Multiple trauma cases
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 |
|---|---|---|
| Leap Motion-based Virtual Reality TherapyArm 1 - Experimental (Leap Motion + Routine Hand Rehabilitation) Intervention Description: Participants will receive standard postoperative hand rehabilitation plus Leap Motion-based virtual reality training. The VR training will be performed for 20 minutes per day, 5 days per week, for 4 weeks, in addition to routine rehabilitation. The Leap Motion Controller tracks hand and finger movements without physical contact and allows participants to practice functional tasks and grasp patterns in a virtual environment. Arm 2 - Active Comparator (Routine Hand Rehabilitation Only) Intervention Description: Participants will receive only routine postoperative hand rehabilitation, performed for 1 hour per day, 5 days per week, for 4 weeks, supervised by a therapist. | Device | Experimental |
| Active Comparator - Routine Rehabilitation OnlyParticipants will receive only routine postoperative hand rehabilitation, performed for 1 hour per day, 5 days per week, for 4 weeks, supervised by a therapist. | Other | Active Comparator (Control) |
Primary outcome
Upper limb disability/function
Time frame: Baseline and 4 weeks post-treatment
Functional disability of the upper limb assessed with the Quick Disabilities of the Arm, Shoulder, and Hand questionnaire. In the Q-DASH, a higher score indicates worse outcome, while a lower score indicates better outcome.
Joint range of motion (ROM)
Time frame: Baseline and 4 weeks post-treatment
Assessed with a manual goniometer. Comparison between baseline and after 4 weeks of treatment. A higher ROM indicates a better clinical condition.
Grip strength
Time frame: Baseline and 4 weeks post-treatment
Assessed using a Jamar hand dynamometer.
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 1 Oct 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Leap Motion-based Virtual Reality Therapy and Active Comparator - Routine Rehabilitation Only in people with Flexor Tendon Injuries of the Hand (Zones II-V), run by Kocaeli University.
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 4 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 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Upper limb disability/function (time frame: Baseline and 4 weeks post-treatment). The study lists 3 primary outcomes in all. 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 1 Oct 2025.