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

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?

Conditions

• Stroke
• Cerebrovascular Accident (Stroke)

Interventions

DEVICE

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 will also include conventional physical therapy, for a total treatment duration of 50 minutes. Participants will receive 12 sessions delivered three times per week over 4 weeks.

OTHER

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, for a total treatment duration of 50 minutes. Participants will receive 12 sessions delivered three times per week over 4 weeks.

OTHER

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 per week over 4 weeks.

Sponsors & Collaborators

• University of Cadiz

  collaborator OTHER

• Universidad Nacional Autonoma de Mexico

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

71 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2027-01-31

Primary Completion

2028-02-29

Completion

2028-04-30

Countries

• Mexico

Study Locations