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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07550270
Enrollment
30
Registered
2026-04-24
Start date
2026-03-26
Completion date
2026-12-01
Last updated
2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Balance, Gait Training, Stroke, Walking Impairment

Keywords

stroke, gait training

Brief 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 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.

Interventions

OTHERVirtual Reality-Assisted Gait Training

Body weight-supported virtual reality-assisted forward gait training with 30% body weight support, applied five days per week for six weeks.

Body weight-supported backward gait training with 30% body weight support, applied five days per week for six weeks.

Body weight-supported forward gait training with 30% body weight support, applied five days per week for six weeks.

Sponsors

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
10-Meter Walk TestAt 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.

Secondary

MeasureTime frameDescription
6-Minute Walk Test (6MWT)At baseline and after 6 weeks of interventionA 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.
Fugl-Meyer Assessment - Lower Extremity Motor SubscaleAt baseline and after 6 weeks of interventionA 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.
Functional Independence Measure (FIM)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.
Berg Balance Scale (BBS)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.
Montreal Cognitive Assessment (MoCA)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.
Stroke-Specific Quality of Life Scale (SS-QOL)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.
Hospital Anxiety and Depression Scale (HADS)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.
Foot RotationAt 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.
Step WidthAt 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.
Step LengthAt 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.
Stance PhaseAt 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.
Swing PhaseAt 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.
Double StanceAt 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.
Gait VelocityAt 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.
CadenceAt 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
Maximum Plantar PressureAt 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.
Center of Pressure, Lateral SymmetryAt 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.

Countries

Turkey (Türkiye)

Contacts

CONTACTIrem ERTORAN INAN, MD
irem.ertoran@gmail.com03122912422
PRINCIPAL_INVESTIGATORTuğba ATAN, Associate Professor, MD

Gaziler Physical Medicine and Rehabilitation Training And Research Hospital

STUDY_CHAIRBilge YILMAZ, Professor, MD

Gaziler Physical Medicine and Rehabilitation Training And Research Hospital

STUDY_DIRECTOREda GÜRÇAY, Professor, MD

Gaziler Physical Medicine and Rehabilitation Training And Research Hospital

STUDY_DIRECTOREngin KOYUNCU, Professor, MD

Gaziler Physical Medicine and Rehabilitation Training And Research Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026