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

NCT07550270 | Recruiting

• 1 other identifier: E2-25-13626
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke; Walking Impairment; Balance; Gait Training

Keywords

stroke; gait training

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline and after 6 weeks of intervention.

Secondary Outcomes (17)

• 6-Minute Walk Test (6MWT)

  At baseline and after 6 weeks of intervention

• Fugl-Meyer Assessment - Lower Extremity Motor Subscale

  At baseline and after 6 weeks of intervention

• Functional Independence Measure (FIM)

  At baseline and after 6 weeks of intervention.

• Berg Balance Scale (BBS)

  At baseline and after 6 weeks of intervention.

• Montreal Cognitive Assessment (MoCA)

  At baseline and after 6 weeks of intervention.

Study Arms (3)

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).

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).

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).

Other: Forward Gait Training

Interventions

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.

Virtual Reality-Assisted Forward Gait Training

Backward Gait Training OTHER

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

Backward Gait Training

Forward Gait Training OTHER

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

Forward Gait Training

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

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

Ankara, Çankaya, 06800, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tuğba ATAN, Associate Professor, MD

  Gaziler Physical Medicine and Rehabilitation Training And Research Hospital

  PRINCIPAL INVESTIGATOR

• Bilge YILMAZ, Professor, MD

  Gaziler Physical Medicine and Rehabilitation Training And Research Hospital

  STUDY CHAIR

• 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 DIRECTOR

Central Study Contacts

Irem ERTORAN INAN, MD

CONTACT

03122912422; irem.ertoran@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tugba Atan, MD, Associate Professor

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: April 24, 2026
• Study Start: March 26, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-03

Locations

TU (1)