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临床试验/NCT07431151
NCT07431151招募中不适用

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

Ankara Yildirim Beyazıt University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2026年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
48
试验地点
1
主要终点
Timed Up and Go Test (TUG)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Experimental Group

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.

干预措施: Virtual Reality-Based Balance and Gait Training (Other)

Experimental Group

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.

干预措施: Conventional Physiotherapy (Other)

Control Group

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.

干预措施: Conventional Physiotherapy (Other)

结局指标

主要结局

Timed Up and Go Test (TUG)

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

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.

Canadian Occupational Performance Measure (COPM)

时间窗: Baseline and post-intervention (15 days)

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.

次要结局

  • Activities-Specific Balance Confidence Scale (ABC)(Baseline and post-intervention (15 days))
  • Stroke-Specific Quality of Life Scale (SS-QoL)(Baseline and post-intervention (15 days))
  • Functional Ambulation Category (FAC)(Baseline and post-intervention (15 days))

研究者

发起方
Ankara Yildirim Beyazıt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Murat Akıncı

Principal Investigator

Ankara City Hospital Bilkent

研究点 (1)

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