Virtual Reality-Based Upper Limb Rehabilitation in Hemiplegia

The Impact of Virtual Reality Games on Upper Extremity Function, Activity, and Participation in Hemiplegic Patients: A Randomized Controlled Trial

This study aims to evaluate the effectiveness of Leap Motion-supported virtual reality therapy, applied in addition to traditional rehabilitation programs, in individuals who develop hemiplegia after a cerebrovascular accident. The study will examine the effects of this additional therapy on upper extremity functions, activities of daily living, and participation levels.

Study Overview

• Status: Completed
• Conditions: Stroke; Virtual Reality Based Therapy; Upper Extremity Hemiplegia
• Intervention / Treatment: Other: conventional rehabilitation; Device: leap motion based virtual reality rehabilitation

Detailed Description

Hemiplegic patients experience significant limitations in their activities of daily living (ADL) and participation levels due to marked losses in upper extremity function following stroke. Approximately 80% of individuals who have had a stroke experience impairment in upper extremity function, and because the upper extremity plays a critical role in many motor functions, these impairments significantly affect independence. Therefore, initiating upper extremity rehabilitation early and tailoring it to the individual's needs is of great importance for functional improvement. Various treatment methods are used in stroke rehabilitation to support physical, functional, and psychological recovery.

In recent years, virtual reality-based technologies have been increasingly used in rehabilitation processes due to their ability to increase motivation, enable intensive and repetitive motor training, and provide environmental feedback. Leap Motion-based virtual reality applications enable patients to participate in therapy through safe, interactive, and task-oriented activities by allowing three-dimensional perception of upper extremity movements.

The aim of this study is to compare the effects of Leap Motion-based virtual reality rehabilitation, applied in addition to conventional treatment, on the functional development of the plegic upper extremity, activities of daily living, and participation levels compared to the group receiving conventional treatment alone.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye), 34255
    • Gaziosmanpasa Research and Education Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients must be above eighteen years of age
• Have had a first-time stroke
• Be within twelve months of stroke
• Have a Brunnstrom score of four or more for the upper extremity
• Be cognitively adequate (scoring ≥23 on the mini-mental test scale)

Exclusion Criteria:

• Being in the unstable phase of the disease
• Visual and/or auditory impairments
• Unilateral spatial neglect (hemineglect)
• Modified Ashworth Scale score of ≥3 in the affected upper limb
• Had a history of botulinum toxin A (Botox) injection in the affected upper limb within the previous six months
• Other systemic neuromuscular disorders (exc; Alzheimer Disease, Parkinson Disease, Multipl Sclerosis...)
• Have cerebellar involvement characterised by dysmetria, dysdiadochokinesia or ataxia
• Have a prior orthopaedic or neuromuscular injuries affecting both upper limbs
• Have impaired static sitting balance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group; The control group received conventional rehabilitation for 1 hour every day, 5 days a week for 4 weeks.	Other: conventional rehabilitation; Conventional rehabilitation consisted of joint range of motion exercises, stretching, strengthening, balance and postural control training, transfer training, gait training, stair climbing exercises, and neurophysiological exercise techniques, all performed under the supervision of a physiotherapist.
Active Comparator: experimental group; In addition to conventional rehabilitation, participants in the experimental group received Leap Motion-based virtual reality therapy 5 days per week for 4 weeks. For this purpose, the Leap Motion device, leased from Becure GmbH (GOSB Teknopark Hightech Building, Gebze, Kocaeli, Turkey), was used to deliver a computer-based HandROM program designed to improve upper extremity functions. Each session consisted of 4 games, played for 10 minutes each, resulting in a total of 40 minutes of additional upper extremity exercise per day. Four therapeutic games used in intervention are as follows: Leap Maze, Leap Ball , Pong and CatchAPet. During the games, patients performed forearm pronation-supination, wrist flexion-extension, and finger flexion-extension movements.	Other: conventional rehabilitation; Conventional rehabilitation consisted of joint range of motion exercises, stretching, strengthening, balance and postural control training, transfer training, gait training, stair climbing exercises, and neurophysiological exercise techniques, all performed under the supervision of a physiotherapist.; Device: leap motion based virtual reality rehabilitation; The VR system was implemented using the Leap Motion device, which incorporates an infrared depth sensor capable of detecting limb movements in three-dimensional space. This technology enables users to interact with the virtual environment without the need for a handheld controller; instead, the user's upper extremities function directly as the interface. During the intervention, patients participated in computer-based rehabilitation while seated, with the motion sensor positioned to accurately capture hand and wrist movements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer assessment for upper extremity	In our study, we used the upper extremity motor evaluation part of the Fugl-Meyer scale. This scale is valid and reliable in evaluating motor recovery after stroke. This scale has 4 subheadings: arm evaluation (maximum 36 points), wrist evaluation (10 points), hand evaluation (maximum 14 points), coordination and speed (maximum 6 points). It consists of 33 items scored from 0 to 2. '0: Cannot realize, 1: Partially realizes, 2: Completely realizes'. A maximum of 66 points can be obtained in the upper extremity scoring. Higher scores indicate better motor recovery.	baseline (T0), at the end of treatment (T1), one month after treatment completion (T2), and three months after treatment completion (T3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Selective Control of the Upper Extremity Scale	It evaluates selective movements in the shoulder, elbow, forearm, wrist and fingers. The person to be evaluated is seated at a table wearing appropriate clothing so that his or her extremities can be clearly seen. The assessor himself shows how to perform the movements. Then the participant actively performs the movement. While the participant is performing the movements, the movements of the head, trunk and both extremities are recorded on a video camera so that they are fully visible. Scoring for each joint is "Normal Selective Motor Control" (3 points), "Mildly Decreased Selective Motor Control" (2 points), "Moderately Decreased Selective Motor Control" (1 point), and "No Selective Motor Control" (0 points). score). A maximum of 15 points can be obtained for the extremity evaluated. A higher score indicates better selective motor control in that limb.	baseline (T0), at the end of treatment (T1), one month after treatment completion (T2), and three months after treatment completion (T3)
Stroke Specific Quality of Life Scale	It is used to evaluate quality of life after stroke. SS-QOL consists of 12 subsections (mobility (6 items), energy (3 items), upper extremity function (5 items), work/production (3 items), temperament (5 items), self-care (5 items), social role (5 items). item), family role (3 items), vision (3 items), language (5 items), thinking (3 items) and personality traits (3 items) and a total of 49 questions. Each question was rated with a Likert-type score ranging from 1 to 5. Rating "1. "I couldn't do it at all, 2. I found it very difficult, 3. I found it a little difficult, 4. I found it very little difficult, 5. I did not find it difficult at all." A maximum of 245 points can be obtained. A high scale score indicates a high quality of life, and a low scale score indicates a low quality of life.	baseline (T0), at the end of treatment (T1), one month after treatment completion (T2), and three months after treatment completion (T3)
Turkish Version of Disabilities of The Arm, Shoulder and Hand	This questionnaire was developed to evaluate the functional status and ability to perform activities of daily living in patients with upper extremity injuries. In our study, the first part of the DASH-T survey, consisting of 30 questions, was applied. Of these 30 questions, 21 evaluate the person's difficulties during daily living activities, 5 evaluate the symptoms (pain, stiffness, tingling, weakness), and 4 evaluate work, sleep, social function and self-confidence. The person answers all questions according to a 5-point Likert system (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: not able to do it at all). When calculating the total score, the total score of the marked items is divided by the number of marked items and subtracted by 1. The result is then multiplied by 25. A score between 0-100 is obtained. As the score increases, the disability also increases.	baseline (T0), at the end of treatment (T1), one month after treatment completion (T2), and three months after treatment completion (T3)
nine hole peg test	The Nine-Hole Peg Test (NHPT) is a simple test of manual dexterity. It assesses fine motor coordination and finger-hand speed. Participants pick up nine pegs from a container, one by one, and insert them into the holes on a pegboard as quickly as possible. Participants must remove pegs one by one and return them to the container after inserting them. The stopwatch records the time taken. Longer times indicate poorer manual dexterity	baseline (T0), at the end of treatment (T1), one month after treatment completion (T2), and three months after treatment completion (T3)

Collaborators and Investigators

• Sponsor: Gaziosmanpasa Research and Education Hospital
• Investigators: Principal Investigator: Pinar Dogan, MD, Gaziosmanpasa Research and Education Hospital

Publications and helpful links

General Publications

• Ogun MN, Kurul R, Yasar MF, Turkoglu SA, Avci S, Yildiz N. Effect of Leap Motion-based 3D Immersive Virtual Reality Usage on Upper Extremity Function in Ischemic Stroke Patients. Arq Neuropsiquiatr. 2019 Oct 24;77(10):681-688. doi: 10.1590/0004-282X20190129. eCollection 2019.
• Wang ZR, Wang P, Xing L, Mei LP, Zhao J, Zhang T. Leap Motion-based virtual reality training for improving motor functional recovery of upper limbs and neural reorganization in subacute stroke patients. Neural Regen Res. 2017 Nov;12(11):1823-1831. doi: 10.4103/1673-5374.219043.
• Shin JH, Kim MY, Lee JY, Jeon YJ, Kim S, Lee S, Seo B, Choi Y. Effects of virtual reality-based rehabilitation on distal upper extremity function and health-related quality of life: a single-blinded, randomized controlled trial. J Neuroeng Rehabil. 2016 Feb 24;13:17. doi: 10.1186/s12984-016-0125-x.

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2023
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: virtual reality; upper extremity; stroke rehabilitation; motor skills; leap motion
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data obtained from patients participating in the statistical analysis will be shared without disclosing patient identities.
• IPD Sharing Time Frame: After the study results are published, these data will be made available for use. Study data can be shared for one year
• IPD Sharing Access Criteria: Upon request, and subject to ethical approval or data usage agreements, the data will be shared with qualified researchers affiliated with academic or medical institutions. Data can be obtained by Principal Investigator Email Address: pinar.karagoz94@gmail.com
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No