Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:20 AM
Study NCT ID:
NCT07431151
Status:
RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Intensive Virtual Reality-Based Balance and Gait Training on Activity Performance and Quality of Life in Subacute Stroke Patients
Sponsor:
Ankara Yildirim Beyazıt University
Organization:
Study Overview
Official Title:
The Effects of Intensive Virtual Reality-Based Balance and Gait Training on Activity Performance and Quality of Life in Individuals With Subacute Stroke
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Stroke is a leading cause of long-term disability worldwide. In the subacute phase, defined as the first six months after stroke, individuals frequently experience impaired balance, reduced gait adaptability, decreased activity performance, and diminished quality of life. Deficits in postural control and increased postural sway contribute to elevated fall risk and reduced community participation. Evidence suggests that the early post-stroke period represents a critical window for neuroplasticity, during which intensive and task-specific rehabilitation may significantly enhance motor recovery.
Virtual reality (VR)-based rehabilitation has emerged as an innovative therapeutic modality that integrates repetitive, task-oriented training with enriched multisensory feedback. VR systems provide real-time visual and auditory feedback, increase patient engagement, and promote motor learning principles such as high repetition, progressive challenge, and goal-directed practice. Previous studies have demonstrated that VR-based gait and balance training may improve functional mobility and postural control in stroke survivors. However, the optimal timing and intensity of such interventions during the subacute phase remain insufficiently explored.
This randomized controlled trial is designed to investigate the effects of intensive VR-based balance and gait training on activity performance, balance confidence, functional mobility, and stroke-specific quality of life in individuals with subacute stroke. Participants who meet the eligibility criteria will be randomly assigned to one of two parallel groups using a computer-generated randomization sequence.
All participants will receive routine conventional physiotherapy consisting of one hour of standard rehabilitation per session. In addition, the intervention group will receive an extra 30-minute session of VR-based balance and gait training per treatment day. The VR program includes progressive weight-shifting tasks, stepping exercises, and gait-related activities delivered through immersive or semi-immersive systems. Training intensity will be progressively adjusted according to individual performance levels, ensuring task-specific and graded motor challenge. Safety harness systems providing body-weight support will be used during sessions to minimize fall risk.
The control group will continue to receive conventional physiotherapy alone during the study period and will receive VR-based training after completion of the waiting period to ensure ethical balance. Outcome assessments will be conducted by a blinded assessor in a dedicated laboratory setting.
Primary and secondary outcomes will include functional mobility (Timed Up and Go Test), balance confidence (Activities-specific Balance Confidence Scale), cognitive status (Montreal Cognitive Assessment), functional ambulation level (Functional Ambulation Category), activity performance (Canadian Occupational Performance Measure), and stroke-specific quality of life (Stroke-Specific Quality of Life Scale). Assessments will be performed at baseline and immediately after completion of the intervention period.
The results of this study are expected to provide evidence regarding the effectiveness of intensified VR-based rehabilitation during the subacute phase of stroke and may contribute to optimizing rehabilitation timing and dosage strategies in clinical practice.
Virtual reality (VR)-based rehabilitation has emerged as an innovative therapeutic modality that integrates repetitive, task-oriented training with enriched multisensory feedback. VR systems provide real-time visual and auditory feedback, increase patient engagement, and promote motor learning principles such as high repetition, progressive challenge, and goal-directed practice. Previous studies have demonstrated that VR-based gait and balance training may improve functional mobility and postural control in stroke survivors. However, the optimal timing and intensity of such interventions during the subacute phase remain insufficiently explored.
This randomized controlled trial is designed to investigate the effects of intensive VR-based balance and gait training on activity performance, balance confidence, functional mobility, and stroke-specific quality of life in individuals with subacute stroke. Participants who meet the eligibility criteria will be randomly assigned to one of two parallel groups using a computer-generated randomization sequence.
All participants will receive routine conventional physiotherapy consisting of one hour of standard rehabilitation per session. In addition, the intervention group will receive an extra 30-minute session of VR-based balance and gait training per treatment day. The VR program includes progressive weight-shifting tasks, stepping exercises, and gait-related activities delivered through immersive or semi-immersive systems. Training intensity will be progressively adjusted according to individual performance levels, ensuring task-specific and graded motor challenge. Safety harness systems providing body-weight support will be used during sessions to minimize fall risk.
The control group will continue to receive conventional physiotherapy alone during the study period and will receive VR-based training after completion of the waiting period to ensure ethical balance. Outcome assessments will be conducted by a blinded assessor in a dedicated laboratory setting.
Primary and secondary outcomes will include functional mobility (Timed Up and Go Test), balance confidence (Activities-specific Balance Confidence Scale), cognitive status (Montreal Cognitive Assessment), functional ambulation level (Functional Ambulation Category), activity performance (Canadian Occupational Performance Measure), and stroke-specific quality of life (Stroke-Specific Quality of Life Scale). Assessments will be performed at baseline and immediately after completion of the intervention period.
The results of this study are expected to provide evidence regarding the effectiveness of intensified VR-based rehabilitation during the subacute phase of stroke and may contribute to optimizing rehabilitation timing and dosage strategies in clinical practice.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: