Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07550270

Body Weight-Supported and Virtual Reality Gait Training in Stroke Patients

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara, Çankaya, Türkiye (Türkiye), 06800 Gaziler Physical Medicine and Rehabilitation Training And Research Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location status: Recruiting

Location contact

Tuğba ATAN

CONTACT

[email protected]

0 312 291 10 00

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality-Assisted Gait Training

Other

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

Backward Gait Training

Other

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

Forward Gait Training

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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

  16. 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.

  17. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Irem ERTORAN INAN, MD

CONTACT

[email protected]

03122912422

Sponsors and collaborators

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.