Effects of Task-Oriented Sit-to-Stand Training Using Immersive VR and PNF on Quality of Life in Chronic Stroke: Trial Protocol

Официальное название

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

Обзор

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?

Вмешательства

• Устройство Immersive Virtual Reality group
  Participants will receive task-oriented STS training using an immersive virtual reality system (Meta Quest 3 with NeuroRehab software). The intervention will include gamified neurorehabilitation exercises targeting weight shifting, center of mass displacement, postural control, motor coordination, anticipatory postural adjustments, and reaction time. The duration of IVR exposure will progressively increase up to 20 minutes per session to enhance tolerance and minimize cybersickness. Each session
• Другое Proprioceptive Neuromuscular Facilitation group
  Participants will receive task-oriented STS training based on PNF concept. The intervention will include techniques aimed at improving neuromuscular activation, postural control, weight-bearing symmetry, motor learning, and functional performance during the different phases of the STS movement. The program will progress from biomechanical and neuromuscular preparation activities to functional STS practice and motor control training. Each session will also include conventional physical therapy, f
• Другое Conventional therapy group
  Participants will receive conventional physical therapy based on current stroke rehabilitation guidelines. Treatment will include active-assisted mobility exercises, strengthening, proprioceptive stimulation, management of spasticity when present, balance training in sitting and standing, weight-shifting activities, and functional task practice, including sit-to-stand training as clinically indicated. Each session will last 50 minutes. Participants will receive 12 sessions delivered three times

Первичные конечные точки

• Quality of Life Measure [Срок оценки: Baseline (T0), immediately after completion of the 4-week intervention (T1), and 12 weeks after the end of the intervention (T2).]

Вторичные конечные точки (6)

• Sit-to-Stand duration [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline (T0), immediately after completion of the 4-week intervention (T1), and 12 weeks after the end of the intervention (T2).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Мексика · 1 центр

• Escuela Nacional de Estudios Superiores, Unidad León — León

Идентификаторы

NCT: NCT07713446 · CEI_25_214_S56_R · Not Applicable (N/A)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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