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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07201740
Enrollment
66
Registered
2025-10-01
Start date
2025-10-01
Completion date
2026-02-01
Last updated
2025-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICELeap 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.

OTHERActive 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.

Sponsors

Kocaeli University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Upper limb disability/functionBaseline and 4 weeks post-treatmentFunctional 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)Baseline and 4 weeks post-treatmentAssessed with a manual goniometer. Comparison between baseline and after 4 weeks of treatment. A higher ROM indicates a better clinical condition.
Grip strengthBaseline and 4 weeks post-treatmentAssessed using a Jamar hand dynamometer.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026