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

NCT ID: NCT07201740

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-02-01

Brief 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). 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Leap Motion-based Virtual Reality Therapy

Intervention Type: 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 (Control)

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)

Group Type: ACTIVE_COMPARATOR

Active Comparator - Routine Rehabilitation Only

Intervention Type: 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.

Interventions

Leap Motion-based Virtual Reality Therapy

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.

Intervention Type: DEVICE

Active Comparator - Routine Rehabilitation Only

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kocaeli University

OTHER

Sponsor Role: lead

Responsible Party

Serkan Kablanoğlu

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

KC-KABLANOGLU-001

Identifier Type: -

Identifier Source: org_study_id