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Completed

NCT Number: NCT07693413

Investigation of the Effects of Mixed Reality Application on the Upper Extremity in Individuals With Hemiparetic Stroke

The aim of this study is to investigate the effectiveness of mixed reality (MR)-based rehabilitation applications in improving motor functions, trunk stability, and upper extremity performance in stroke patients. The use of mixed reality technology in addition to traditional rehabilitation methods provides individuals with an interactive and motivating rehabilitation environment that mimics real-life activities. The study aims to increase functional independence, improve motor skills and trunk stability, enhance upper extremity functions, facilitate return to daily living activities, increase adaptation and motivation to the rehabilitation process, and provide a repeatable, safe, and patient-centered exercise environment in stroke patients. This thesis aims to contribute to both clinical physiotherapy practice and the literature by evaluating the applicability of mixed reality technology, a patient-centered and innovative rehabilitation approach, as a treatment option in neurological rehabilitation. The study's objective in improving upper extremity function is to make the individual less dependent on others while performing daily living activities, to instill a sense of self-sufficiency, and to enhance existing skills to make them more functional.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasan Kalyoncu Univercity

Gaziantep, 27000, Turkey (Türkiye)

About this study

The aim of this study is to investigate the effectiveness of mixed reality (MR)-based rehabilitation applications in improving motor functions, trunk stability, and upper extremity performance in stroke patients. The use of mixed reality technology in addition to traditional rehabilitation methods provides individuals with an interactive and motivating rehabilitation environment that mimics real-life activities. The population and sample of the study will consist of adult individuals with upper extremity functional limitations and stroke who are receiving treatment at the Gaziantep Metropolitan Municipality Accessible Living Center. The study will be divided into two groups, a study group and a control group, using stratified randomization. The study group will undergo upper extremity exercises using the Reach VR mixed reality application, while the control group will receive a conventional treatment program. This thesis aims to contribute to both clinical physiotherapy practice and the literature by evaluating the applicability of mixed reality technology, a patient-centered and innovative rehabilitation approach, as a treatment option in neurological rehabilitation. The aim of this study, which focuses on improving upper extremity function, is to make the individual less dependent on others for daily living activities, to instill a sense of self-sufficiency, and to enhance existing skills, thereby making them more functional.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals aged 18-65 who have experienced a stroke.
  • At least 6 months must have passed since the stroke.
  • FIM independence scale score of 50 or higher.
  • Fugl-Meyer Upper Extremity Assessment (FMA) score between 23-66.
  • Mini Mental Test score above 24.

Exclusion criteria

  • Presence of current epileptic seizures.
  • Upper extremity spasticity 3-4.
  • Visual or hearing loss that would affect the study.
  • Individuals who have experienced multiple strokes.

Treatment and study plan

traditional therapy

Other

The treatment will last 8 weeks, 3 days a week, with each session lasting 30 minutes. Participants will receive traditional physiotherapy treatment, including upper extremity strengthening, motor skills exercises, and balance exercises.

Virtual Reality

Other

The treatment will last 8 weeks, 3 days a week, with each session lasting 30 minutes. Participants will be playing Reach VR within the Meta Quest 3 using the eye.

Primary outcomes

  1. Modified Box and Block Test - mBBT

    Time frame: Baseline (prior to the start of treatment) and immediately after completion of the 8 week invertion.

    The individual performs this test with both their dominant and non-dominant hand. mBBT reflects a direct assessment of individuals' upper extremity functional performance based on the number of blocks transferred from one compartment to the other within 30 seconds. At the end of the time period, the number of blocks transferred to the opposite compartment is recorded.

Secondary outcomes

  1. L-Shape Test

    Time frame: Baseline (prior to the start of treatment) and immediately after completion of the 8 week invertion.

    This test is applied to objectively measure safe walking and turning performance in individuals with lower extremity injuries or balance disorders. The test course is created on the ground in the shape of the letter L. A line is determined, usually consisting of 3 meters of straight walking from the starting point, followed by a 90-degree turn, and then approximately 7 meters of walking again. The corner of the course is the most critical part of the test in terms of evaluating the individual's ability to change direction. During the application, the individual is asked to proceed at a normal and safe walking speed from the starting point, turn at the corner, and complete the course. The test duration is recorded in seconds using a stopwatch.

  2. Action Research Arm Test -ARAT

    Time frame: Baseline (prior to the start of treatment) and immediately after completion of the 8 week invertion.

    The test objectively assesses an individual's grasping, holding, carrying, and fine motor skills required for daily living activities. ARAT examines upper extremity function under four subheadings: Grasp, Grip, Pinch (Fine grip), and Gross Movement. The Grasp subtest evaluates the ability to grasp and carry blocks of varying sizes and shapes, while the Grip subtest examines the controlled grasping of smaller objects. Each item is scored between 0 and 3. The total score ranges from 0 to 57. A higher score indicates better upper extremity function.

  3. İmpairment Scale - TIS

    Time frame: Baseline (prior to the start of treatment) and immediately after completion of the 8 week invertion.

    This scale provides important information about functional mobility by examining trunk stability and selective trunk movements in a seated position. It is evaluated out of a total of 17 points. Subtopics include static, dynamic sitting balance, and coordination.

  4. BlazePod

    Time frame: Baseline (prior to the start of treatment) and immediately after completion of the 8 week invertion.

    This is a technology-based measurement and exercise system used to evaluate reaction time, upper and lower extremity function, balance, coordination, and cognitive-motor integration, particularly in stroke patients. Consisting of wireless, illuminated pod devices, this system quantitatively measures performance by assessing motor responses such as touching, reaching, or stepping in response to illuminated stimuli. It offers a more dynamic and task-oriented assessment compared to traditional clinical tests.

  5. Specific Quality of Life Scale (SS-QOL)

    Time frame: Baseline (prior to the start of treatment) and immediately after completion of the 8 week invertion.

    It is widely used in rehabilitation to evaluate treatment effectiveness and monitor patient-centered outcomes. The SS-QOL consists of 12 sub-dimensions that assess stroke-specific quality of life. These sub-areas include energy, family roles, language, mobility, mood, personality, self-care, social roles, cognition, upper extremity function, vision, and work/productivity.

  6. Client satisfaction Questionnaire - CSQ 8

    Time frame: At the end of the 8 week invertion.

    The CSQ-8 provides important feedback in determining the client's perception and satisfaction with the treatment process. The CSQ-8 consists of 8 items, each questioning a different aspect of the service provided. The scale includes satisfaction indicators such as the quality of service received, the extent to which expectations are met, suitability to needs, benefit derived from the service, willingness to choose the same service again, and tendency to recommend it to others.

Sponsors and collaborators

Lead sponsor

Emine Ece Bedir Ayar

Other

Registry information

Official study title

Investigation of the Effects of Mixed Reality Application on Upper Extremity Motor Functions and Trunk Stability in Individuals With Hemiparetic Stroke

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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