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

NCT07713446 | Not Yet Recruiting

• 2 other identifiers: CEI_25_214_S56_RNot Applicable (N/A)
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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?

Conditions

Stroke; Cerebrovascular Accident (Stroke)

Keywords

stroke; Propioceptive Neuromuscular Facilitation; PNF; Immersive Virtual Reality; Sit to Stand

Outcome Measures

Primary Outcomes (1)

• Quality of Life Measure

  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.

  Baseline (T0), immediately after completion of the 4-week intervention (T1), and 12 weeks after the end of the intervention (T2).

Secondary Outcomes (6)

• 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).

Other Outcomes (1)

• User satisfaction with immersive virtual reality

  After completion of the 4-week intervention (T1)

Study Arms (3)

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; Other: Conventional therapy group

Convetional Therapy

ACTIVE 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

Interventions

Immersive Virtual Reality group DEVICE

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.

Immersive Virtual Reality Group (IVR-G)

Proprioceptive Neuromuscular Facilitation group OTHER

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.

Proprioceptive Neuromuscular Facilitation Group (PNF-G)

Conventional therapy group OTHER

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.

Convetional Therapy; Immersive Virtual Reality Group (IVR-G); Proprioceptive Neuromuscular Facilitation Group (PNF-G)

Eligibility Criteria

• Age: 35 Years - 71 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional Autonoma de Mexico: lead
• University of Cadiz: collaborator

Study Sites (1)

Escuela Nacional de Estudios Superiores, Unidad León

León, Guanajuato, 37689, Mexico

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Carlos R Palma Reyes, Master's Degree

CONTACT

+52 477 194 0800; cpalma@enes.unam.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor in the Bachelor of Physical Therapy Program, Escuela Nacional de Estudios Superiores, Universidad Nacional Autónoma de México (UNAM).

Model Details: Participants will be randomly assigned to one of three parallel groups: 1. IVR group receiving task-oriented STS training combined with conventional therapy, 2. PNF group receiving task-oriented sit-to-stand training based on PNF 3. Control group receiving conventional therapy.

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 20, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)