StrokeNCT07550270
Body Weight-Supported and Virtual Reality Gait Training in Stroke Patients
A study testing Virtual Reality-Assisted Gait Training, Backward Gait Training and Forward Gait Training in people with Stroke and Walking Impairment, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the effects of body weight-supported gait training that includes virtual reality-assisted dual-task applications with body weight-supported forward and backward gait training on functional capacity, gait parameters (such as step length, gait speed, and balance), cognitive functions… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Stroke, Walking Impairment, Balance
- What is being tested?
- Virtual Reality-Assisted Gait Training, Backward Gait Training and Forward Gait Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Mar 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients experiencing their first-ever stroke
- Patients with a post-stroke duration of more than 2 weeks
- Patients with plantar flexor muscle spasticity of the lower extremity less than grade 3 according to the Modified Ashworth Scale (MAS)
- Patients with a Brunnstrom stage of the lower extremity greater than 2
- Patients who are able to stand independently or under supervision for at least 2 minutes for standing assessments
- Patients who are able to walk at least 10 meters independently or under supervision, with or without an assistive device, for walking assessments
Show all 9Show fewer
- Patients with sufficient cognitive function to understand study instructions (Mini-Mental State Examination [MMSE] score > 23)
- Patients with stable medical and psychological conditions
- Patients who are willing to participate in the study
Who cannot join
- Patients with bilateral hemispheric lesions
- Patients with severe cardiovascular or musculoskeletal conditions that prevent walking (e.g., fixed ankle contracture)
- Patients using a permanent urinary catheter, or those with pressure ulcers or urinary and/or fecal incontinence
- Patients with unilateral neglect
- Patients with neurological conditions other than stroke that may affect balance performance (e.g., Parkinson's disease, epilepsy, meningitis, cerebellar disorders, vertigo, dizziness, polyneuropathy) or musculoskeletal disorders (e.g., severe low back pain, knee disorders)
- Patients with severe visual, hearing, or speech impairments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara, Çankaya, Türkiye (Türkiye), 06800 Gaziler Physical Medicine and Rehabilitation Training And Research Hospital
Ankara, Çankaya, 06800
Tuğba ATAN, 0 312 291 10 00, tubaatan@gmail.com
About this study
Official title: A Comparative Evaluation of the Effectiveness of Body Weight-Supported Forward and Backward Gait Training Versus Virtual Reality-Assisted Gait Training in Patients With Stroke
The aim of this study is to compare the effects of body weight-supported gait training that includes virtual reality-assisted dual-task applications with body weight-supported forward and backward gait training on functional capacity, gait parameters (such as step length, gait speed, and balance), cognitive functions and psychological status in patients with stroke. The findings of this study are expected to contribute to the development of more effective rehabilitation strategies for improving mobility in patients with stroke
Read the detailed description
Stroke is a leading cause of disability worldwide and often results in motor, balance, and cognitive impairments that negatively affect functional independence and quality of life. Walking limitations are among the most common consequences after stroke and represent a major barrier to community participation. Therefore, improving gait performance and functional mobility is a primary goal of stroke rehabilitation.
Body weight-supported gait training is widely used to improve walking ability in individuals with impaired balance and reduced motor function. In recent years, rehabilitation technologies such as virtual reality-assisted gait training have been increasingly incorporated into clinical practice. Virtual reality may enhance patient engagement and promote both motor and cognitive recovery by providing interactive environments and increasing task demands.
Backward walking training has also gained attention as an alternative rehabilitation approach. Compared to forward walking, backward walking requires greater postural control and cognitive processing, similar to dual-task training, and may contribute to improvements in balance and gait performance. However, there is limited evidence directly comparing virtual reality-assisted dual-task gait training with backward walking training in patients with stroke.
This study aims to compare the effects of body weight-supported virtual reality-assisted dual-task gait training and body weight-supported forward and backward gait training on functional capacity, gait parameters, cognitive functions, and psychological status in patients with stroke. The findings of this study are expected to contribute to the development of more effective rehabilitation strategies for improving mobility and functional outcomes in stroke rehabilitation.
- Conditions
- Stroke, Walking Impairment, Balance, Gait Training
- Being tested
- Virtual Reality-Assisted Gait Training, Backward Gait Training, Forward Gait Training
- Keywords
- stroke, gait training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-Assisted Gait TrainingOther
Body weight-supported virtual reality-assisted forward gait training with 30% body weight support, applied five days per week for six weeks.
Backward Gait TrainingOther
Body weight-supported backward gait training with 30% body weight support, applied five days per week for six weeks.
Forward Gait TrainingOther
Body weight-supported forward gait training with 30% body weight support, applied five days per week for six weeks.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality-Assisted Forward Gait Training | Experimental | Participants in this group will receive conventional rehabilitation, including physiotherapy, occupational therapy, and speech, language, and swallowing therapy, for six weeks (five days per week, approximately 2-3 hours per day). In addition, participants will undergo body weight-supported virtual reality-assisted forward gait training with 30% body weight support for six weeks (five days per week, 30 minutes per day). Receives: Other: Virtual Reality-Assisted Gait Training |
| Backward Gait Training | Experimental | Participants in this group will receive conventional rehabilitation, including physiotherapy, occupational therapy, and speech, language, and swallowing therapy, for six weeks (five days per week, approximately 2-3 hours per day). In addition, participants will undergo body weight-supported backward gait training with 30% body weight support for six weeks (five days per week, 30 minutes per day). Receives: Other: Backward Gait Training |
| Forward Gait Training | Experimental | Participants in this group will receive conventional rehabilitation, including physiotherapy, occupational therapy, and speech, language, and swallowing therapy, for six weeks (five days per week, approximately 2-3 hours per day). In addition, participants will undergo body weight-supported forward gait training with 30% body weight support for six weeks (five days per week, 30 minutes per day). Receives: Other: Forward Gait Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
10-Meter Walk Test
A measure used to assess patients' ambulation. During the test, the patient walks at a comfortable walking speed between two markers placed 10 meters apart, and the time required to complete the distance is recorded.
Measured: At baseline and after 6 weeks of intervention.
Secondary outcomes (17)
6-Minute Walk Test (6MWT)
A submaximal exercise test commonly used to assess functional capacity and response to treatment. During the test, participants are instructed to walk as far as possible within six minutes. The total distance walked is recorded as an indicator of cardiopulmonary capacity and exercise tolerance.
Measured: At baseline and after 6 weeks of intervention
Fugl-Meyer Assessment - Lower Extremity Motor Subscale
A standardized assessment used to evaluate sensorimotor impairment in individuals with stroke. The lower extremity motor subscale measures motor recovery and functional movement of the lower limb following stroke.
Measured: At baseline and after 6 weeks of intervention
Functional Independence Measure (FIM)
A widely used assessment tool for evaluating functional abilities in individuals undergoing rehabilitation. The scale assesses both motor and cognitive domains, including self-care, sphincter control, transfers, mobility, communication, and social interaction.
Measured: At baseline and after 6 weeks of intervention.
Berg Balance Scale (BBS)
A widely used clinical test for assessing static and dynamic balance abilities. The test consists of a series of functional balance tasks, each scored on a scale from 0 (unable) to 4 (independent), with the total score representing overall balance performance.
Measured: At baseline and after 6 weeks of intervention.
Montreal Cognitive Assessment (MoCA)
A brief cognitive screening tool used to assess cognitive functions, including memory, attention, language, visuospatial abilities, executive functions, calculation, and orientation. The test is scored on a 30-point scale, with higher scores indicating better cognitive performance.
Measured: At baseline and after 6 weeks of intervention.
Stroke-Specific Quality of Life Scale (SS-QOL)
A standardized measure used to assess health-related quality of life in individuals with stroke, covering physical, emotional, and social domains affected by the condition.
Measured: At baseline and after 6 weeks of intervention.
Hospital Anxiety and Depression Scale (HADS)
A 14-item self-report questionnaire designed to assess the presence and severity of anxiety and depression symptoms in clinical populations.
Measured: At baseline and after 6 weeks of intervention.
Foot Rotation
Gait analysis will be performed using the Zebris RehaWalk® system. Foot rotation (foot progression angle) quantifies the angular deviation of the foot relative to the direction of walking, measured in degrees.
Measured: At baseline and after 6 weeks of intervention.
Step Width
Gait analysis will be performed using the Zebris RehaWalk® system. Step width measures the mediolateral distance between the heel centers of consecutive footfalls during walking.
Measured: At baseline and after 6 weeks of intervention.
Step Length
Gait analysis will be performed using the Zebris RehaWalk® system. Step length measures the anteroposterior distance between the heel contact point of one foot and the heel contact point of the contralateral foot during walking.
Measured: At baseline and after 6 weeks of intervention.
Stance Phase
Gait analysis will be performed using the Zebris RehaWalk® system. Stance phase represents the percentage of the gait cycle during which the foot remains in contact with the ground.
Measured: At baseline and after 6 weeks of intervention.
Swing Phase
Gait analysis will be performed using the Zebris RehaWalk® system. Swing phase represents the percentage of the gait cycle during which the foot is off the ground.
Measured: At baseline and after 6 weeks of intervention.
Double Stance
Gait analysis will be performed using the Zebris RehaWalk® system. Double stance represents the percentage of the gait cycle during which both feet are simultaneously in contact with the ground.
Measured: At baseline and after 6 weeks of intervention.
Gait Velocity
Gait analysis will be performed using the Zebris RehaWalk® system. Gait velocity measures the distance covered per unit time during walking, with reduced speed being one of the most sensitive indicators of hemiparetic gait impairment post-stroke.
Measured: At baseline and after 6 weeks of intervention.
Cadence
Gait analysis will be performed using the Zebris RehaWalk® system. Cadence measures the number of steps taken per minute during walking, reflecting the temporal coordination of the gait cycle
Measured: At baseline and after 6 weeks of intervention.
Maximum Plantar Pressure
Gait analysis will be performed using the Zebris RehaWalk® system. Maximum plantar pressure measures the peak pressure exerted on the foot sole during the stance phase of gait.
Measured: At baseline and after 6 weeks of intervention.
Center of Pressure, Lateral Symmetry
Gait analysis will be performed using the Zebris RehaWalk® system. Center of Pressure (COP) Lateral Symmetry measures the mediolateral displacement of the center of pressure between the paretic and non-paretic limbs during walking, reported in millimeters.
Measured: At baseline and after 6 weeks of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start26 Mar 2026
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba Atan, MD, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Investigators
- Tuğba ATAN, Associate Professor, MD, Principal investigator, Gaziler Physical Medicine and Rehabilitation Training And Research HospitalBilge YILMAZ, Professor, MD, Study chair, Gaziler Physical Medicine and Rehabilitation Training And Research HospitalEda GÜRÇAY, Professor, MD, Study director, Gaziler Physical Medicine and Rehabilitation Training And Research HospitalEngin KOYUNCU, Professor, MD, Study director, Gaziler Physical Medicine and Rehabilitation Training And Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550270
- Sponsor's protocol ID
- E2-25-13626
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of the Effectiveness of Body Weight-Supported Forward and Backward Gait Training Versus Virtual Reality-Assisted Gait Training in Patients With Stroke
- ClinicalTrials.gov ID
- NCT07550270
- Acronym / sponsor ID
- E2-25-13626
- Conditions
- Stroke, Walking Impairment, Balance, Gait Training
- Keywords
- stroke, gait training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 26 Mar 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Apr 2026 (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.
The aim of this study is to compare the effects of body weight-supported gait training that includes virtual reality-assisted dual-task applications with body weight-supported forward and backward gait training on functional capacity, gait parameters (such as step length, gait speed, and balance), cognitive functions and psychological status in patients with stroke. The findings of this study are expected to contribute to the development of more effective rehabilitation strategies for improving mobility in patients with stroke
Detailed description
Stroke is a leading cause of disability worldwide and often results in motor, balance, and cognitive impairments that negatively affect functional independence and quality of life. Walking limitations are among the most common consequences after stroke and represent a major barrier to community participation. Therefore, improving gait performance and functional mobility is a primary goal of stroke rehabilitation.
Body weight-supported gait training is widely used to improve walking ability in individuals with impaired balance and reduced motor function. In recent years, rehabilitation technologies such as virtual reality-assisted gait training have been increasingly incorporated into clinical practice. Virtual reality may enhance patient engagement and promote both motor and cognitive recovery by providing interactive environments and increasing task demands.
Backward walking training has also gained attention as an alternative rehabilitation approach. Compared to forward walking, backward walking requires greater postural control and cognitive processing, similar to dual-task training, and may contribute to improvements in balance and gait performance. However, there is limited evidence directly comparing virtual reality-assisted dual-task gait training with backward walking training in patients with stroke.
This study aims to compare the effects of body weight-supported virtual reality-assisted dual-task gait training and body weight-supported forward and backward gait training on functional capacity, gait parameters, cognitive functions, and psychological status in patients with stroke. The findings of this study are expected to contribute to the development of more effective rehabilitation strategies for improving mobility and functional outcomes in stroke rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality-Assisted Forward Gait Training | Experimental | Other: Virtual Reality-Assisted Gait TrainingParticipants in this group will receive conventional rehabilitation, including physiotherapy, occupational therapy, and speech, language, and swallowing therapy, for six weeks (five days per week, approximately 2-3 hours per day). In addition, participants will undergo body weight-supported virtual reality-assisted forward gait training with 30% body weight support for six weeks (five days per week, 30 minutes per day). |
| Backward Gait Training | Experimental | Other: Backward Gait TrainingParticipants in this group will receive conventional rehabilitation, including physiotherapy, occupational therapy, and speech, language, and swallowing therapy, for six weeks (five days per week, approximately 2-3 hours per day). In addition, participants will undergo body weight-supported backward gait training with 30% body weight support for six weeks (five days per week, 30 minutes per day). |
| Forward Gait Training | Experimental | Other: Forward Gait TrainingParticipants in this group will receive conventional rehabilitation, including physiotherapy, occupational therapy, and speech, language, and swallowing therapy, for six weeks (five days per week, approximately 2-3 hours per day). In addition, participants will undergo body weight-supported forward gait training with 30% body weight support for six weeks (five days per week, 30 minutes per day). |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients experiencing their first-ever stroke
- Patients with a post-stroke duration of more than 2 weeks
- Patients with plantar flexor muscle spasticity of the lower extremity less than grade 3 according to the Modified Ashworth Scale (MAS)
- Patients with a Brunnstrom stage of the lower extremity greater than 2
- Patients who are able to stand independently or under supervision for at least 2 minutes for standing assessments
Key exclusion criteria (6 listed)
- Patients with bilateral hemispheric lesions
- Patients with severe cardiovascular or musculoskeletal conditions that prevent walking (e.g., fixed ankle contracture)
- Patients using a permanent urinary catheter, or those with pressure ulcers or urinary and/or fecal incontinence
- Patients with unilateral neglect
- Patients with neurological conditions other than stroke that may affect balance performance (e.g., Parkinson's disease, epilepsy, meningitis, cerebellar disorders, vertigo, dizziness, polyneuropathy) or musculoskeletal disorders (e.g., severe low back pain, knee disorders)
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 |
|---|---|---|
| Virtual Reality-Assisted Gait TrainingBody weight-supported virtual reality-assisted forward gait training with 30% body weight support, applied five days per week for six weeks. | Other | Virtual Reality-Assisted Forward Gait Training |
| Backward Gait TrainingBody weight-supported backward gait training with 30% body weight support, applied five days per week for six weeks. | Other | Backward Gait Training |
| Forward Gait TrainingBody weight-supported forward gait training with 30% body weight support, applied five days per week for six weeks. | Other | Forward Gait Training |
Primary outcome
10-Meter Walk Test
Time frame: At baseline and after 6 weeks of intervention.
A measure used to assess patients' ambulation. During the test, the patient walks at a comfortable walking speed between two markers placed 10 meters apart, and the time required to complete the distance is recorded.
17 secondary outcomes
6-Minute Walk Test (6MWT)
Time frame: At baseline and after 6 weeks of intervention
Fugl-Meyer Assessment - Lower Extremity Motor Subscale
Time frame: At baseline and after 6 weeks of intervention
Functional Independence Measure (FIM)
Time frame: At baseline and after 6 weeks of intervention.
Berg Balance Scale (BBS)
Time frame: At baseline and after 6 weeks of intervention.
Montreal Cognitive Assessment (MoCA)
Time frame: At baseline and after 6 weeks of intervention.
Stroke-Specific Quality of Life Scale (SS-QOL)
Time frame: At baseline and after 6 weeks of intervention.
Hospital Anxiety and Depression Scale (HADS)
Time frame: At baseline and after 6 weeks of intervention.
Foot Rotation
Time frame: At baseline and after 6 weeks of intervention.
Step Width
Time frame: At baseline and after 6 weeks of intervention.
Step Length
Time frame: At baseline and after 6 weeks of intervention.
Stance Phase
Time frame: At baseline and after 6 weeks of intervention.
Swing Phase
Time frame: At baseline and after 6 weeks of intervention.
Double Stance
Time frame: At baseline and after 6 weeks of intervention.
Gait Velocity
Time frame: At baseline and after 6 weeks of intervention.
Cadence
Time frame: At baseline and after 6 weeks of intervention.
Maximum Plantar Pressure
Time frame: At baseline and after 6 weeks of intervention.
Center of Pressure, Lateral Symmetry
Time frame: At baseline and after 6 weeks of intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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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.
Tuğba ATAN, Associate Professor, MD principal investigator
Gaziler Physical Medicine and Rehabilitation Training And Research Hospital
Bilge YILMAZ, Professor, MD study chair
Gaziler Physical Medicine and Rehabilitation Training And Research Hospital
Eda GÜRÇAY, Professor, MD study director
Gaziler Physical Medicine and Rehabilitation Training And Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-Assisted Gait Training, Backward Gait Training and Forward Gait Training in people with Stroke and Walking Impairment, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital 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 9 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 24 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Irem ERTORAN INAN, MD (03122912422, irem.ertoran@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10-Meter Walk Test (time frame: At baseline and after 6 weeks of intervention.). 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 24 Apr 2026.