Effects of Immersive Virtual Reality- and Proprioceptive Neuromuscular Facilitation-Based Task-Oriented Sit-to-Stand Training on Quality of Life in People With Chronic Stroke: Protocol for a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Quality of Life Measure
研究概览
简要总结
The purpose of this study is to evaluate the effects of two interventions based on different neurophysiological approaches on quality of life in individuals with chronic stroke. The interventions include Immersive Virtual Reality (IVR) and Proprioceptive Neuromuscular Facilitation (PNF), both focused on improving task-oriented sit-to-stand (STS) performance. A control group receiving conventional therapy will also be included. Participants in all three groups will receive 12 treatment sessions delivered three times per week over a 4-week period. The PNF group and the control group will receive 50-minute sessions. The IVR group will receive 10-20 minutes of IVR-based STS training combined with 30-40 minutes of conventional therapy, for a total session duration of 50 minutes.
The primary outcome will be quality of life, assessed using the Newcastle Stroke-Specific Quality of Life Measure (NEWSQOL). Secondary outcomes will include STS kinematic parameters (hip, knee, and ankle angular velocity, center of mass displacement, and STS duration), reaction time to gait iniciation (RTGI) measures, fall risk, lower-limb functional strength and endurance, and user satisfaction with the IVR intervention. The study will be conducted in two phases. The first phase will consist of a pilot study to assess the feasibility of the protocol and identify any necessary adjustments to the experimental procedures. The second phase will involve the implementation of the full randomized controlled trial to evaluate the effectiveness of the interventions.
This study aims to address the following research questions: (1) Does task-oriented STS training using IVR or PNF improve quality of life in individuals with chronic stroke to a greater extent than conventional therapy? (2) Do IVR- and PNF-based interventions lead to greater improvements in STS kinematics, reaction time and gait initiation, balance, and lower-limb functional strength and endurance compared with conventional therapy? (3) Is there an association between changes in STS kinematic parameters and improvements in stroke-specific quality of life following the intervention?
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
- Double (Care Provider, Outcomes Assessor)
盲法说明
Single-Blind Study. Outcome assessors will be blinded to group allocation throughout the study. Assessments will be performed by an independent evaluator who is not involved in treatment delivery. Due to the nature of the interventions, participants cannot be blinded to the treatment received.
入排标准
- 年龄范围
- 35 Years 至 71 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 35 to 71 years.
- •Diagnosis of ischemic or hemorrhagic stroke confirmed by medical records.
- •Chronic stroke, defined as ≥6 months and <2 years since the stroke event.
- •Hemodynamically stable.
- •Ability to maintain sitting and standing positions independently or with minimal assistance.
排除标准
- •Visual impairments that may interfere with the safe or effective use of immersive virtual reality.
- •Photosensitivity.
- •Cognitive impairment and/or communication deficits that prevent understanding or following study instructions.
- •Uncontrolled medical conditions or comorbidities that contraindicate participation in physical rehabilitation, including epilepsy, seizure disorders, cardiac arrhythmias, uncontrolled hypertension, or other significant cardiovascular conditions.
结局指标
主要结局
Quality of Life Measure
时间窗: Baseline (T0), immediately after completion of the 4-week intervention (T1), and 12 weeks after the end of the intervention (T2).
Quality of life will be assessed using the Newcastle Stroke-Specific Quality of Life Measure (NEWSQOL), spanish version. The NEWSQOL is a validated 56-item questionnaire that evaluates the multidimensional impact of stroke across 11 domains: mobility, activities of daily living/self-care, pain/sensation, vision, cognition, communication, feelings, interpersonal relationships, emotions, sleep, and fatigue. Each item is scored on a 4-point scale ranging from 0 (no impact) to 3 (high impact). Domain scores are calculated by summing the corresponding item scores, with higher scores indicating a greater negative impact of stroke on quality of life. Changes in domain scores from baseline to post-intervention will be compared among groups.
次要结局
- Sit-to-Stand duration(Baseline (T0), immediately after completion of the 4-week intervention (T1), and 12 weeks after the end of the intervention (T2))
- Balance and fall risk(Baseline (T0), immediately after completion of the 4-week intervention (T1), and 12 weeks after the end of the intervention (T2))
- Lower-limb functional strength and endurance(Baseline (T0), immediately after completion of the 4-week intervention (T1), and 12 weeks after the end of the intervention (T2))
- Sit to stand to gait transition time(Baseline (T0), immediately after completion of the 4-week intervention (T1), and 12 weeks after the end of the intervention (T2).)
- Peak trunk flexion angular velocity during STS(Baseline (T0), immediately after completion of the 4-week intervention (T1), and 12 weeks after the end of the intervention (T2).)
- Estimated anterior-posterior center of mass displacement during STS(Baseline (T0), immediately after completion of the 4-week intervention (T1), and 12 weeks after the end of the intervention (T2).)
研究者
Carlos Rafael Palma Reyes
Adjunct Professor in the Bachelor of Physical Therapy Program, Escuela Nacional de Estudios Superiores, Universidad Nacional Autónoma de México (UNAM).
Universidad Nacional Autonoma de Mexico