Virtual Reality-Based Upper Limb Rehabilitation in Hemiplegia

NCT07378085 | Completed

• 1 other identifier: 07
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Virtual Reality Based Therapy; Upper Extremity Hemiplegia

Keywords

stroke rehabilitation; virtual reality; upper extremity; motor skills; leap motion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Selective Control of the Upper Extremity Scale

  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

  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

  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

  baseline (T0), at the end of treatment (T1), one month after treatment completion (T2), and three months after treatment completion (T3)

Study Arms (2)

control group

ACTIVE COMPARATOR

The control group received conventional rehabilitation for 1 hour every day, 5 days a week for 4 weeks.

Other: conventional rehabilitation

experimental group

ACTIVE COMPARATOR

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; Device: leap motion based virtual reality rehabilitation

Interventions

leap motion based virtual reality rehabilitation DEVICE

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.

experimental group

conventional rehabilitation OTHER

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.

control group; experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Gaziosmanpasa Research and Education Hospital

Istanbul, 34255, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 31664343 BACKGROUND

• 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.

  PMID: 29239328 BACKGROUND

• 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.

  PMID: 26911438 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Pinar Dogan, MD

  Gaziosmanpasa Research and Education Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study was conducted in a single-blind manner, only the evaluator did not know which patient was in the experimental group and which patient was in the control group. Due to the nature of the treatment, the patients and the occupational therapist performing the game were not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Model Details: The study is a single-blind, prospective, randomized controlled, single-center study. Patients were randomly assigned to the experimental group (EG) or the control group (CG). A box containing 40 opaque, sealed envelopes was prepared: 20 labeled "CG" and 20 "EG". Occupational therapists asked participants to draw one envelope. If they withdrew from the study, the envelope corresponding to their group was returned. The study continued until all 40 envelopes had been drawn and complete data were collected.

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 30, 2026
• Study Start: January 23, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: January 30, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After the study results are published, these data will be made available for use. Study data can be shared for one year
• 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

Locations

TU (1)