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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07378085
Enrollment
40
Registered
2026-01-30
Start date
2023-01-23
Completion date
2023-09-01
Last updated
2026-01-30

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

Conditions

Stroke, Upper Extremity Hemiplegia, Virtual Reality Based Therapy

Keywords

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

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.

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.

Interventions

OTHERconventional 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.

DEVICEleap 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.

Sponsors

Gaziosmanpasa Research and Education Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Fugl-Meyer assessment for upper extremitybaseline (T0), at the end of treatment (T1), one month after treatment completion (T2), and three months after treatment completion (T3)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.

Secondary

MeasureTime frameDescription
Selective Control of the Upper Extremity Scalebaseline (T0), at the end of treatment (T1), one month after treatment completion (T2), and three months after treatment completion (T3)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.
Stroke Specific Quality of Life Scalebaseline (T0), at the end of treatment (T1), one month after treatment completion (T2), and three months after treatment completion (T3)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.
Turkish Version of Disabilities of The Arm, Shoulder and Handbaseline (T0), at the end of treatment (T1), one month after treatment completion (T2), and three months after treatment completion (T3)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.
nine hole peg testbaseline (T0), at the end of treatment (T1), one month after treatment completion (T2), and three months after treatment completion (T3)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

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORPinar Dogan, MD

Gaziosmanpasa Research and Education Hospital

Outcome results

None listed

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