The Effects of Augmented Reality Versus Virtual Reality
NCT ID: NCT07113093
Last Updated: 2025-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
66 participants
INTERVENTIONAL
2025-08-01
2027-05-31
Brief Summary
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Detailed Description
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The C-Mill VR+ system (Motek, Netherlands) is a treadmill equipped with both AR and VR applications, offering visual-auditory feedback, safety harnesses, and force sensors. Though studies suggest C-Mill training improves gait and reduces fall risk in geriatric and Parkinson's disease populations, comprehensive randomized controlled trials comparing AR- and VR-supported treadmill training in stroke rehabilitation are lacking.
This study will enroll 66 individuals with stroke undergoing inpatient rehabilitation at the Virtual Reality Laboratory of Ankara Bilkent City Hospital. Inclusion criteria include diagnosis of hemiplegia (ICD-10 code G81), age 18 or older, and ability to walk with or without assistance (Functional Ambulation Classification ≥ 2). Exclusion criteria include aphasia, MoCA score \<10, additional neurological/orthopedic problems, recurrent stroke, or a Modified Ashworth Scale (MAS) score of 3-4 in the lower extremities. Participants will be randomly assigned to one of three groups: (1) VR group-C-Mill VR treadmill training with Nature Island, Italian Apps, and Soccer applications; (2) AR group-C-Mill AR training using Stepping Stones, Reactive Stones, Obstacles, Speed Adjustment, Slalom, Tandem, and Monster Game applications; (3) Control group-home-based walking exercises (flat ground, variable step length, obstacles, and speed) in addition to standard physiotherapy. All groups will continue routine physiotherapy and receive 45-minute training sessions, five days a week for three weeks.
Outcome measures assessed pre- and post-intervention include the Timed Up and Go Test, Fugl-Meyer Lower Extremity Motor Assessment, Modified Ashworth Scale, Activities-specific Balance Confidence Scale, Berg Balance Scale, Functional Ambulation Classification, Trunk Impairment Scale, Stroke Impact Scale (3.0), Stroke-Specific Quality of Life Scale, Montreal Cognitive Assessment (MoCA), and spatiotemporal gait analysis via the C-Mill VR+ system. Gait analysis will record step lengths, stance and swing phases, and double support percentages for both paretic and non-paretic limbs at self-selected and fixed speeds.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Augmented Reality
In this group, augmented reality will be used during treadmill walking.
Augmented Reality
Gait training will be conducted using the AR applications Stepping Stones, Reactive Stones, Obstacles, Speed Adjustment, Slalom, Tandem, and Monster Game for 45 minutes.
Others
The treatment duration is 60 minutes. Based on the patient's needs, the following exercises will be performed: scapular and thoracolumbar mobilization; upper and lower extremity exercises (range of motion, stretching, and strengthening); bed mobility and transitional movements such as rolling, coming to a sitting position, and standing up; core activation exercises such as bridging and functional reaching; weight shifting and balance training; gait training (e.g., walking between parallel bars, walking in different directions, and walking over obstacles); and cycling on a bicycle ergometer.
Virtual Reality
In this group, virtual reality will be used during treadmill walking.
Virtual Reality
Gait training will be conducted using the VR applications Nature Island, Italian Apps, and Soccer for 45 minutes.
Others
The treatment duration is 60 minutes. Based on the patient's needs, the following exercises will be performed: scapular and thoracolumbar mobilization; upper and lower extremity exercises (range of motion, stretching, and strengthening); bed mobility and transitional movements such as rolling, coming to a sitting position, and standing up; core activation exercises such as bridging and functional reaching; weight shifting and balance training; gait training (e.g., walking between parallel bars, walking in different directions, and walking over obstacles); and cycling on a bicycle ergometer.
Control Group
Participants in this group will be enrolled in a self-directed exercise program that is matched in duration and content to the VR-AR interventions.
Self Directed Exercises
"Patients will be taught exercises including walking on a flat surface, walking with varying step lengths, walking over obstacles, and walking at different speeds. They will be instructed to perform these exercises for 45 minutes per day.
Others
The treatment duration is 60 minutes. Based on the patient's needs, the following exercises will be performed: scapular and thoracolumbar mobilization; upper and lower extremity exercises (range of motion, stretching, and strengthening); bed mobility and transitional movements such as rolling, coming to a sitting position, and standing up; core activation exercises such as bridging and functional reaching; weight shifting and balance training; gait training (e.g., walking between parallel bars, walking in different directions, and walking over obstacles); and cycling on a bicycle ergometer.
Interventions
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Augmented Reality
Gait training will be conducted using the AR applications Stepping Stones, Reactive Stones, Obstacles, Speed Adjustment, Slalom, Tandem, and Monster Game for 45 minutes.
Virtual Reality
Gait training will be conducted using the VR applications Nature Island, Italian Apps, and Soccer for 45 minutes.
Self Directed Exercises
"Patients will be taught exercises including walking on a flat surface, walking with varying step lengths, walking over obstacles, and walking at different speeds. They will be instructed to perform these exercises for 45 minutes per day.
Others
The treatment duration is 60 minutes. Based on the patient's needs, the following exercises will be performed: scapular and thoracolumbar mobilization; upper and lower extremity exercises (range of motion, stretching, and strengthening); bed mobility and transitional movements such as rolling, coming to a sitting position, and standing up; core activation exercises such as bridging and functional reaching; weight shifting and balance training; gait training (e.g., walking between parallel bars, walking in different directions, and walking over obstacles); and cycling on a bicycle ergometer.
Eligibility Criteria
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Inclusion Criteria
* Age 18 years or older
* Ability to walk with assistance or independently (Functional Ambulation Classification score of 2 or higher)
Exclusion Criteria
* Refusal to participate in the study
* Aphasia
* Montreal Cognitive Assessment score below 10
* Presence of extra neurological or orthopedic problems unrelated to stroke
* Recurrent stroke
* MAS score of 3-4 (lower extremity)
* Volunteer's desire to withdraw from the study
* Inability to adapt to the technological devices used in the study (e.g., visual or hearing impairments)
* Missing three consecutive treatment sessions
* Botulinum toxin-A (BONT-A) injection to the lower extremity during the treatment process or within the last 6 months
18 Years
ALL
No
Sponsors
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Ankara Yildirim Beyazıt University
OTHER
Responsible Party
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Murat Akıncı
Principal Investigator
Locations
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Ankara Bilkent City Hospital
Ankara, Çankaya, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VR02
Identifier Type: -
Identifier Source: org_study_id
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