Effects of Intensive Virtual Reality-Based Balance and Gait Training on Activity Performance and Quality of Life in Subacute Stroke Patients

NCT07431151 | Recruiting

• 1 other identifier: Stroke07
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is one of the leading causes of long-term disability worldwide, and balance and gait impairments are common in the subacute phase, limiting activity performance and quality of life. Early and intensive rehabilitation during the first six months after stroke is considered critical for optimizing functional recovery. Virtual reality-based rehabilitation has emerged as a promising approach to enhance motor learning through task-specific, repetitive, and feedback-driven training. This randomized controlled trial aims to investigate the effects of intensive virtual reality-based balance and gait training on activity performance, balance confidence, and quality of life in individuals with subacute stroke. Participants will be randomly allocated to either an intervention group receiving conventional physiotherapy combined with additional virtual reality-based balance and gait training, or a control group receiving conventional physiotherapy alone during the study period. Outcome measures will include functional mobility, balance confidence, cognitive status, and stroke-specific quality of life. The findings of this study may contribute to optimizing rehabilitation intensity and timing strategies in subacute stroke rehabilitation

Conditions

Stroke

Keywords

stroke; virtual reality; rehabilitation; c-mill; augmented reality

Outcome Measures

Primary Outcomes (2)

• Timed Up and Go Test

  The Timed Up and Go Test measures functional mobility. Participants are instructed to stand up from a standard chair (approximately 46 cm height), walk 3 meters at a comfortable and safe pace, turn around, walk back, and sit down. The total time required to complete the task is recorded in seconds. Shorter completion times indicate better functional mobility.

  Baseline and immediately after completion of the 15-session intervention period (15 days)

• Canadian Occupational Performance Measure

  The COPM is a client-centered outcome measure assessing perceived performance and satisfaction in self-care, productivity, and leisure activities. Participants rate identified priority activities on a 10-point scale for performance and satisfaction. Higher scores indicate better perceived performance and satisfaction.

  Baseline and post-intervention (15 days)

Secondary Outcomes (3)

• Activities-Specific Balance Confidence Scale

  Baseline and post-intervention (15 days)

• Stroke-Specific Quality of Life Scale

  Baseline and post-intervention (15 days)

• Functional Ambulation Category

  Baseline and post-intervention (15 days)

Other Outcomes (1)

• Montreal Cognitive Assessment

  Time Frame: Baseline only (screening measure)

Study Arms (2)

Virtual Reality-Based Balance and Gait Training + Conventional Physiotherapy

OTHER

Participants in the experimental group will receive routine conventional physiotherapy (60 minutes per session) combined with an additional 30 minutes of virtual reality-based balance and gait training per treatment day for a total of 15 sessions. The VR intervention will include task-specific balance and gait activities such as weight shifting, stepping exercises, and progressive gait tasks delivered through immersive or semi-immersive virtual reality systems. Training intensity and task difficulty will be progressively adjusted according to individual performance levels. A body-weight support safety harness will be used during sessions to minimize fall risk.

Other: Virtual Reality-Based Balance and Gait Training; Other: Conventional Physiotherapy

Conventional Physiotherapy

OTHER

Participants in the control group will receive routine conventional physiotherapy (60 minutes per session) for 15 sessions during the study period. After completion of the study assessments, participants in this group will be offered virtual reality-based balance and gait training.

Other: Conventional Physiotherapy

Interventions

Virtual Reality-Based Balance and Gait Training OTHER

Participants will receive an additional 30-minute session of virtual reality-based balance and gait training per treatment day for a total of 15 sessions, alongside routine conventional physiotherapy. The VR program will include task-specific exercises targeting balance and walking, such as weight-shifting, stepping, and gait-related tasks selected from a pre-defined exercise pool and individualized according to participant needs. Task difficulty will be progressed within and across sessions based on performance. Active exercise time will be recorded; rest periods due to fatigue will not be counted as active training time. A safety harness providing body-weight support will be used during training to minimize fall risk.

Virtual Reality-Based Balance and Gait Training + Conventional Physiotherapy

Conventional Physiotherapy OTHER

Participants will receive routine conventional physiotherapy consisting of 60 minutes per session for a total of 15 sessions. The program will be delivered as part of standard inpatient/outpatient physiotherapy care and will include conventional rehabilitation components aimed at improving balance, mobility, and functional capacity, as clinically indicated.

Conventional Physiotherapy; Virtual Reality-Based Balance and Gait Training + Conventional Physiotherapy

Eligibility Criteria

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

You may qualify if:

• Diagnosis of hemiplegia (ICD-10 code G81)
• Age ≥ 18 years
• Montreal Cognitive Assessment (MoCA) score \> 10

You may not qualify if:

• Failure to attend three consecutive treatment sessions during the study period
• Receiving additional balance- or gait-specific rehabilitation interventions (e.g., robot-assisted gait training) during the study period

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara Bilkent City 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

Central Study Contacts

Murat Akıncı

CONTACT

+905529356978; muratakinci.fzt@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: February 24, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

TU (1)