StrokeNCT07113093
The Effects of Augmented Reality Versus Virtual Reality
A study testing Augmented Reality, Virtual Reality and Self Directed Exercises in people with Stroke, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to compare the effects of augmented reality (AR) and virtual reality (VR)-assisted treadmill gait training on balance and walking in individuals with stroke, within the framework of the International Classification of Functioning, Disability and Health (ICF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Augmented Reality, Virtual Reality and Self Directed Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICD-10 diagnosis code of G.81 (Hemiplegia)
- Age 18 years or older
- Ability to walk with assistance or independently (Functional Ambulation Classification score of 2 or higher)
Who cannot join
- Incomplete completion of the assessment form
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Çankaya, 06800
About this study
Official title: Effects of Augmented Reality and Virtual Reality-Assisted Gait Training on Balance and Walking in Individuals With Stroke
This randomized controlled trial aims to compare the effects of augmented reality (AR) and virtual reality (VR)-assisted treadmill gait training on balance and walking in individuals with stroke, within the framework of the International Classification of Functioning, Disability and Health (ICF). A total of 66 post-stroke patients will be randomly assigned to three groups: (1) VR group receiving gait training via C-Mill VR applications in addition to conventional physiotherapy, (2) AR group receiving gait training via C-Mill AR applications in addition to conventional physiotherapy, and (3) control group receiving a home exercise program alongside conventional physiotherapy. Participants will train for 45 minutes per day, five days a week, for three weeks. Outcome measures will include clinical, functional, cognitive, and spatiotemporal gait parameters to evaluate changes in balance and walking ability before and after the intervention.
Read the detailed description
This prospective, randomized controlled study aims to compare the effects of augmented reality (AR) and virtual reality (VR)-assisted treadmill gait training on balance and walking in individuals with stroke, and to contribute to the literature through a comprehensive analysis within the International Classification of Functioning, Disability and Health (ICF) framework. Stroke is a leading cause of long-term disability and care burden, with nearly one-third of acute stroke survivors unable to walk three months after onset. Improving walking ability is a central goal of stroke rehabilitation. There is increasing evidence that high-intensity, task-specific, and repetitive training can enhance functional recovery. Treadmill training enables intensive, repetitive practice of complex gait patterns and has been shown to improve walking speed and distance in stroke survivors. Technological advances have introduced immersive tools such as VR and AR systems into rehabilitation, providing engaging and interactive environments that enhance motor learning and patient motivation.
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
- Stroke
- Being tested
- Augmented Reality, Virtual Reality, Self Directed Exercises, Others
- Keywords
- Stroke, Virtual Reality, Augmented Reality, Treadmill
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented RealityOther
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 RealityOther
Gait training will be conducted using the VR applications Nature Island, Italian Apps, and Soccer for 45 minutes.
Self Directed ExercisesOther
"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.
OthersOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Augmented Reality | Experimental | In this group, augmented reality will be used during treadmill walking. Receives: Other: Augmented Reality; Other: Others |
| Virtual Reality | Experimental | In this group, virtual reality will be used during treadmill walking. Receives: Other: Virtual Reality; Other: Others |
| Control Group | Other | 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. Receives: Other: Self Directed Exercises; Other: Others |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go (TUG) Test
To perform the test, the patient stands up from a chair approximately 46 cm in height, walks at a comfortable and safe pace to a marked target three meters away, turns around the target, and returns to sit back down on the chair. To ensure familiarity with the procedure, the patient performs one trial without timing. If needed, the patient may use their usual walking aid (e.g., cane or walker). A shorter completion time indicates better performance.
Measured: baseline and after 3 weeks
Berg Balance Scale (BBS)
The scale consists of 14 items and assesses the patient's ability to maintain balance (either static or during various functional movements) over a specific period of time. Each item is scored on a scale from 0 to 4:
0 points: Unable to complete the task. 4 points: Completes the task independently. The maximum total score is 56. A score of 0-20 indicates poor balance, 21-40 indicates acceptable balance, and 41-56 indicates good balance.
Measured: baseline and after 3 weeks
Gait Analsis
Spatio-temporal gait analysis will be performed using the C-Mill VR+ device. As a result of this measurement, step lengths, stance phases (%), swing phases (%), and double support phases (%) of the paretic and non-paretic limbs will be recorded. Gait analysis will be conducted in two separate assessments: at the participant's self-selected comfortable walking speed and at a fixed speed of 1 km/h. The gait analysis will begin after a 2-minute warm-up period, and data will be collected for the following 2 minutes. A rest period of at least 5 minutes will be provided between the two assessments.
Measured: baseline and after 3 weeks
Secondary outcomes (6)
Fugl-Meyer Motor Assessment Lower Extremity (FMA-LE)
The FMA is a widely used, valid, and reliable test for evaluating motor impairments of the paretic upper and lower extremities in stroke patients. Each item on the scale is scored as follows: 0 = unable to perform, 1 = performs partially, and 2 = performs fully. Higher scores indicate better motor function. In this study, the 34-point lower extremity section of the scale will be used.
Measured: baseline and after 3 weeks
Activities-specific Balance Confidence (ABC) Scale
The ABC Scale is a 16-item self-assessment questionnaire that asks individuals to rate their confidence in maintaining balance during specific ambulatory activities on a numerical scale from 0 to 100. A score of 0 represents no confidence at all, while a score of 100 represents complete confidence in performing the activity. Each participant's total ABC score is calculated by summing the scores for each item and then dividing by the number of items. Botner et al. reported that the scale can be used to assess fear of falling in individuals with stroke. Myers and colleagues suggested that ABC scores below 50 indicate low physical function, scores between 50 and 80 indicate moderate physical function, and scores above 80 indicate high functionality among physically active older adults.
Measured: baseline and after 3 weeks
Functional Ambulation Category (FAC)
The FAC is a valid and reliable scale used in patients with post-stroke hemiparesis that classifies walking ability into six levels based on the amount of physical assistance required. A score of 0 indicates that the patient needs assistance from two people to walk, while a score of 5 represents independent walking on all surfaces including stairs.
Measured: baseline and after 3 weeks
Trunk Impairment Scale (TIS)
The scale was developed to assess trunk function after stroke. It consists of three sections: static sitting balance, dynamic sitting balance, and coordination. Due to a ceiling effect in the static sitting balance section, a revised version was developed in 2010 that excludes this section. This new version is recommended for patients with mild to moderate impairment and those in the chronic phase.
Measured: baseline and after 3 weeks
Stroke Impact Scale (SIS) Version 3.0
The SIS is a comprehensive health status measure specifically designed for stroke. It consists of 8 domains and 59 items. Each item is rated on a scale from 1 to 5. For items 3f, 3h, and 3i in domain 3, reverse scoring is applied using the formula (6 - the marked score). A new domain has been added to assess the patient's overall perception of recovery, where the patient rates their recovery on a scale from 0 to 100. The score for each subdomain is calculated using the formula:
Subdomain Score = ((Mean Item Score - 1) / 4) × 100
Measured: baseline and after 3 weeks
Stroke-Specific Quality of Life Scale (SS-QOL)
The scale consists of 12 domains-Thinking, Personality, Mood, Family Roles, Social Roles, Energy, Self-Care, Vision, Language, Mobility, Work/Productivity, and Upper Extremity Function-and includes a total of 49 items. Each item is scored using a 5-point Likert scale based on the patient's experience during the past week. The overall quality of life score is the sum of the scores from all subdomains. Higher scores indicate better quality of life. Subdomains can also be analyzed independently to identify specific areas of difficulty.
Measured: baseline and after 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Aug 2025
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Akıncı, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113093
- Sponsor's protocol ID
- VR02
- Status last verified
- Aug 2025
- First submitted
- 30 Jul 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Augmented Reality and Virtual Reality-Assisted Gait Training on Balance and Walking in Individuals With Stroke
- ClinicalTrials.gov ID
- NCT07113093
- Acronym / sponsor ID
- VR02
- Conditions
- Stroke
- Keywords
- Stroke, Virtual Reality, Augmented Reality, Treadmill
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial aims to compare the effects of augmented reality (AR) and virtual reality (VR)-assisted treadmill gait training on balance and walking in individuals with stroke, within the framework of the International Classification of Functioning, Disability and Health (ICF). A total of 66 post-stroke patients will be randomly assigned to three groups: (1) VR group receiving gait training via C-Mill VR applications in addition to conventional physiotherapy, (2) AR group receiving gait training via C-Mill AR applications in addition to conventional physiotherapy, and (3) control group receiving a home exercise program alongside conventional physiotherapy. Participants will train for 45 minutes per day, five days a week, for three weeks. Outcome measures will include clinical, functional, cognitive, and spatiotemporal gait parameters to evaluate changes in balance and walking ability before and after the intervention.
Detailed description
This prospective, randomized controlled study aims to compare the effects of augmented reality (AR) and virtual reality (VR)-assisted treadmill gait training on balance and walking in individuals with stroke, and to contribute to the literature through a comprehensive analysis within the International Classification of Functioning, Disability and Health (ICF) framework. Stroke is a leading cause of long-term disability and care burden, with nearly one-third of acute stroke survivors unable to walk three months after onset. Improving walking ability is a central goal of stroke rehabilitation. There is increasing evidence that high-intensity, task-specific, and repetitive training can enhance functional recovery. Treadmill training enables intensive, repetitive practice of complex gait patterns and has been shown to improve walking speed and distance in stroke survivors. Technological advances have introduced immersive tools such as VR and AR systems into rehabilitation, providing engaging and interactive environments that enhance motor learning and patient motivation.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Augmented Reality | Experimental | Other: Augmented Reality, Other: OthersIn this group, augmented reality will be used during treadmill walking. |
| Virtual Reality | Experimental | Other: Virtual Reality, Other: OthersIn this group, virtual reality will be used during treadmill walking. |
| Control Group | Other | Other: Self Directed Exercises, Other: OthersParticipants in this group will be enrolled in a self-directed exercise program that is matched in duration and content to the VR-AR interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ICD-10 diagnosis code of G.81 (Hemiplegia)
- Age 18 years or older
- Ability to walk with assistance or independently (Functional Ambulation Classification score of 2 or higher)
Key exclusion criteria (11 listed)
- Incomplete completion of the assessment form
- Refusal to participate in the study
- Aphasia
- Montreal Cognitive Assessment score below 10
- Presence of extra neurological or orthopedic problems unrelated to stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented RealityGait training will be conducted using the AR applications Stepping Stones, Reactive Stones, Obstacles, Speed Adjustment, Slalom, Tandem, and Monster Game for 45 minutes. | Other | Augmented Reality |
| Virtual RealityGait training will be conducted using the VR applications Nature Island, Italian Apps, and Soccer for 45 minutes. | Other | Virtual Reality |
| 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. | Other | Control Group |
| OthersThe 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. | Other | Augmented Reality, Control Group, Virtual Reality |
Primary outcome
Timed Up and Go (TUG) Test
Time frame: baseline and after 3 weeks
To perform the test, the patient stands up from a chair approximately 46 cm in height, walks at a comfortable and safe pace to a marked target three meters away, turns around the target, and returns to sit back down on the chair. To ensure familiarity with the procedure, the patient performs one trial without timing. If needed, the patient may use their usual walking aid (e.g., cane or walker). A shorter completion time indicates better performance.
Berg Balance Scale (BBS)
Time frame: baseline and after 3 weeks
The scale consists of 14 items and assesses the patient's ability to maintain balance (either static or during various functional movements) over a specific period of time. Each item is scored on a scale from 0 to 4: 0 points: Unable to complete the task. 4 points: Completes the task independently. The maximum total score is 56. A score of 0-20 indicates poor balance, 21-40 indicates acceptable balance, and 41-56 indicates good balance.
Gait Analsis
Time frame: baseline and after 3 weeks
Spatio-temporal gait analysis will be performed using the C-Mill VR+ device. As a result of this measurement, step lengths, stance phases (%), swing phases (%), and double support phases (%) of the paretic and non-paretic limbs will be recorded. Gait analysis will be conducted in two separate assessments: at the participant's self-selected comfortable walking speed and at a fixed speed of 1 km/h. The gait analysis will begin after a 2-minute warm-up period, and data will be collected for the following 2 minutes. A rest period of at least 5 minutes will be provided between the two assessments.
6 secondary outcomes
Fugl-Meyer Motor Assessment Lower Extremity (FMA-LE)
Time frame: baseline and after 3 weeks
Activities-specific Balance Confidence (ABC) Scale
Time frame: baseline and after 3 weeks
Functional Ambulation Category (FAC)
Time frame: baseline and after 3 weeks
Trunk Impairment Scale (TIS)
Time frame: baseline and after 3 weeks
Stroke Impact Scale (SIS) Version 3.0
Time frame: baseline and after 3 weeks
Stroke-Specific Quality of Life Scale (SS-QOL)
Time frame: baseline and after 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Reality, Virtual Reality and Self Directed Exercises in people with Stroke, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go (TUG) Test (time frame: baseline and after 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.