Effects of Task-Oriented Sit-to-Stand Training Using Immersive VR and PNF on Quality of Life in Chronic Stroke: Trial Protocol | NCT07713446

NCT07713446

Overview

NCT ID: NCT07713446
Lead Sponsor: Universidad Nacional Autonoma de MexicoOTHER
Official Title: 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
Brief 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?

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 20, 2026Actual
Start Date: Jan 2027Estimated
Primary Completion Date: Feb 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 93Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts and Locations

Central Contacts: Carlos R Palma Reyes, Master's DegreeContact
cpalma@enes.unam.mx+52 477 194 0800

Similar Studies

Participant Group/Arms

Immersive Virtual Reality Group (IVR-G)Experimental

Participants will receive task-oriented STS training using IVR combined with conventional physical therapy. IVR training will focus on weight shifting, center of mass displacement, postural control, motor coordination, and reaction time through gamified neurorehabilitation exercises. Treatment will be delivered three times per week for 4 weeks (12 sessions).

Device: Immersive Virtual Reality group

Other: Conventional therapy group

Proprioceptive Neuromuscular Facilitation Group (PNF-G)Experimental

Participants will receive task-oriented STS training based on PNF concept combined with conventional physical therapy. The intervention will focus on improving neuromuscular activation, postural control, weight-bearing symmetry, motor control, and functional STS performance. Treatment will be delivered three times per week for 4 weeks (12 sessions).

Other: Proprioceptive Neuromuscular Facilitation group

Convetional TherapyActive Comparator

Participants will receive conventional physical therapy based on current stroke rehabilitation guidelines. Treatment will include functional mobility exercises, strengthening, balance training, weight-shifting activities, and functional task practice, including STS training as clinically indicated. Treatment will be delivered three times per week for 4 weeks (12 sessions).

Other: Conventional therapy group