Clinical Trial

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

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Summary
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?
Trial Details
NCT Number NCT07713446
Lead Sponsor Universidad Nacional Autonoma de Mexico
Collaborators: University of Cadiz
Conditions Stroke, Cerebrovascular Accident (Stroke)
Enrollment 93 participants
Start Date 2027-01
Primary Completion 2028-02 (estimated)
Study Completion 2028-04 (estimated)
Updated on ClinicalTrials.gov 2026-07-20