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NCT Number: NCT07201740

The Effectiveness of Leap Motion-Based Virtual Reality in the Rehabilitation of Flexor Tendon Injuries of the Hand

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.

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Key information

Conditions

Flexor Tendon Injuries of the Hand (Zones II-V)

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Communication problems

Cognitive impairment

Additional musculoskeletal, neurological, or rheumatological diseases affecting upper extremity function

Multiple trauma cases

Treatment and study plan

Leap Motion-based Virtual Reality Therapy

Device

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 Only

Other

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Oct 1, 2025
Registry last updated: Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.