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

Kocaeli University

Status: Not yet enrolling

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

Treatments: Device: Leap Motion-based Virtual Reality Therapy; Other: Active Comparator - Routine Rehabilitation Only

Study type: Interventional

Funder types: Other

Identifiers

NCT07201740

KC-KABLANOGLU-001

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Experimental

Experimental group

Description:

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)

Treatment:

Device: Leap Motion-based Virtual Reality Therapy

Active Comparator (Control)

Active Comparator group

Description:

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)

Treatment:

Other: Active Comparator - Routine Rehabilitation Only