- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07550270
Body Weight-Supported and Virtual Reality Gait Training in Stroke Patients
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Irem ERTORAN INAN, MD
- Phone Number: 03122912422
- Email: irem.ertoran@gmail.com
Study Locations
-
-
Çankaya
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Ankara, Çankaya, Turkey (Türkiye), 06800
- Recruiting
- Ankara, Çankaya, Türkiye (Türkiye), 06800 Gaziler Physical Medicine and Rehabilitation Training And Research Hospital
-
Contact:
- Tuğba ATAN
- Phone Number: 0 312 291 10 00
- Email: tubaatan@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual Reality-Assisted Forward Gait Training
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).
|
Body weight-supported virtual reality-assisted forward gait training with 30% body weight support, applied five days per week for six weeks.
|
|
Experimental: Backward Gait Training
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).
|
Body weight-supported backward gait training with 30% body weight support, applied five days per week for six weeks.
|
|
Experimental: Forward Gait Training
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).
|
Body weight-supported forward gait training with 30% body weight support, applied five days per week for six weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At baseline and after 6 weeks of intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
6-Minute Walk Test (6MWT)
Time Frame: At baseline and after 6 weeks of intervention
|
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.
|
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
|
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.
|
At baseline and after 6 weeks of intervention
|
|
Functional Independence Measure (FIM)
Time Frame: At baseline and after 6 weeks of intervention.
|
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.
|
At baseline and after 6 weeks of intervention.
|
|
Berg Balance Scale (BBS)
Time Frame: At baseline and after 6 weeks of intervention.
|
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.
|
At baseline and after 6 weeks of intervention.
|
|
Montreal Cognitive Assessment (MoCA)
Time Frame: At baseline and after 6 weeks of intervention.
|
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.
|
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.
|
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.
|
At baseline and after 6 weeks of intervention.
|
|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: At baseline and after 6 weeks of intervention.
|
A 14-item self-report questionnaire designed to assess the presence and severity of anxiety and depression symptoms in clinical populations.
|
At baseline and after 6 weeks of intervention.
|
|
Foot Rotation
Time Frame: At baseline and after 6 weeks of intervention.
|
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.
|
At baseline and after 6 weeks of intervention.
|
|
Step Width
Time Frame: At baseline and after 6 weeks of intervention.
|
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.
|
At baseline and after 6 weeks of intervention.
|
|
Step Length
Time Frame: At baseline and after 6 weeks of intervention.
|
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.
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At baseline and after 6 weeks of intervention.
|
|
Stance Phase
Time Frame: At baseline and after 6 weeks of intervention.
|
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.
|
At baseline and after 6 weeks of intervention.
|
|
Swing Phase
Time Frame: At baseline and after 6 weeks of intervention.
|
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.
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At baseline and after 6 weeks of intervention.
|
|
Double Stance
Time Frame: At baseline and after 6 weeks of intervention.
|
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.
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At baseline and after 6 weeks of intervention.
|
|
Gait Velocity
Time Frame: At baseline and after 6 weeks of intervention.
|
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.
|
At baseline and after 6 weeks of intervention.
|
|
Cadence
Time Frame: At baseline and after 6 weeks of intervention.
|
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
|
At baseline and after 6 weeks of intervention.
|
|
Maximum Plantar Pressure
Time Frame: At baseline and after 6 weeks of intervention.
|
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.
|
At baseline and after 6 weeks of intervention.
|
|
Center of Pressure, Lateral Symmetry
Time Frame: At baseline and after 6 weeks of intervention.
|
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.
|
At baseline and after 6 weeks of intervention.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Tuğba ATAN, Associate Professor, MD, Gaziler Physical Medicine and Rehabilitation Training and Research Hospital
- Study Chair: Bilge YILMAZ, Professor, MD, Gaziler Physical Medicine and Rehabilitation Training and Research Hospital
- Study Director: Eda GÜRÇAY, Professor, MD, Gaziler Physical Medicine and Rehabilitation Training and Research Hospital
- Study Director: Engin KOYUNCU, Professor, MD, Gaziler Physical Medicine and Rehabilitation Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E2-25-13626
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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