Effects of Task-Oriented Sit-to-Stand Training Using Immersive VR and PNF on Quality of Life in Chronic Stroke: Trial Protocol
16 luglio 2026 aggiornato da: Carlos Rafael Palma Reyes, Universidad Nacional Autonoma de Mexico
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
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?
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Tipo di studio
Interventistico
Iscrizione (Stimato)
93
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Carlos R Palma Reyes, Master's Degree
- Numero di telefono: +52 477 194 0800
- Email: cpalma@enes.unam.mx
Luoghi di studio
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Guanajuato
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León, Guanajuato, Messico, 37689
- Escuela Nacional de Estudios Superiores, Unidad León
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Contatto:
- Carlos R Palma Reyes, Master's Degree
- Numero di telefono: +52 477194 0800
- Email: cpalma@enes.unam.mx
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Immersive Virtual Reality Group (IVR-G)
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).
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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.
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.
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Sperimentale: Proprioceptive Neuromuscular Facilitation Group (PNF-G)
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).
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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.
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.
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Comparatore attivo: Convetional Therapy
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).
|
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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Quality of Life Measure
Lasso di tempo: Baseline (T0), immediately after completion of the 4-week intervention (T1), and 12 weeks after the end of the intervention (T2).
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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.
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Baseline (T0), immediately after completion of the 4-week intervention (T1), and 12 weeks after the end of the intervention (T2).
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Sit-to-Stand duration
Lasso di tempo: Baseline (T0), immediately after completion of the 4-week intervention (T1), and 12 weeks after the end of the intervention (T2)
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Sit-to-Stand (STS) duration will be assessed using the PhysioMaster smartphone-based inertial measurement system.
Raw inertial measurement unit (IMU) data will be exported to MATLAB for signal processing, including low-pass filtering at 5 Hz, before kinematic analysis.
STS duration will be defined as the total time (seconds) required to complete the STS movement, from movement onset to achievement of a stable upright standing position.
Three trials will be performed under standardized conditions, and the mean value will be used for statistical analysis.
Shorter STS duration indicates more efficient functional performance during the STS task.
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Baseline (T0), immediately after completion of the 4-week intervention (T1), and 12 weeks after the end of the intervention (T2)
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Balance and fall risk
Lasso di tempo: Baseline (T0), immediately after completion of the 4-week intervention (T1), and 12 weeks after the end of the intervention (T2)
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Balance and fall risk will be assessed using the Berg Balance Scale (BBS).
The BBS evaluates performance during progressively challenging tasks, including transfers, standing, turning, reaching, and postural control activities.
Each item is scored on a 5-point ordinal scale from 0 to 4, yielding a total score ranging from 0 to 56 points.
Higher scores indicate better balance performance and lower fall risk.
Changes in BBS scores from baseline to post-intervention and follow-up will be compared among groups.
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Baseline (T0), immediately after completion of the 4-week intervention (T1), and 12 weeks after the end of the intervention (T2)
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Lower-limb functional strength and endurance
Lasso di tempo: Baseline (T0), immediately after completion of the 4-week intervention (T1), and 12 weeks after the end of the intervention (T2)
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Lower-limb functional strength and endurance will be assessed using the 30-Second Sit-to-Stand Test (30s-STS).
Participants will be instructed to stand up and sit down from a standard chair as many times as possible within 30 seconds.
The total number of completed repetitions will be recorded.
Higher scores indicate greater lower-limb functional strength and endurance, whereas lower scores are associated with poorer functional performance and an increased risk of falls.
Changes in the number of repetitions from baseline to post-intervention and follow-up will be compared among groups.
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Baseline (T0), immediately after completion of the 4-week intervention (T1), and 12 weeks after the end of the intervention (T2)
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Sit to stand to gait transition time
Lasso di tempo: Baseline (T0), immediately after completion of the 4-week intervention (T1), and 12 weeks after the end of the intervention (T2).
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Sit to stand to gait (STS-GI) transition time will be assessed as the time required to initiate gait immediately after performing a STS task. Participants will be seated on a standardized chair with both feet placed comfortably on the floor and will be instructed to remain still until an auditory cue ("Go") is provided. Upon the cue, participants will stand up as quickly and safely as possible and immediately begin walking at their self-selected comfortable speed. The STS-GI will be the transition time (seconds), defined as the interval between the auditory cue and the onset of the first step, operationally defined as the instant when the leading foot leaves the ground (foot-off). Lower values indicate more efficient movement initiation and better functional mobility. Changes in time to start gate from baseline to post-intervention and follow-up 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).
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Peak trunk flexion angular velocity during STS
Lasso di tempo: Baseline (T0), immediately after completion of the 4-week intervention (T1), and 12 weeks after the end of the intervention (T2).
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Peak trunk angular velocity during the STS task will be measured using the PhysioMaster smartphone-based inertial measurement system.
Raw IMU data will be exported to MATLAB and filtered at 5 Hz before analysis.
The variable represents the maximum angular velocity (°/s) of trunk flexion achieved during the momentum-generation phase of the STS movement.
Higher peak angular velocity reflects a faster trunk flexion strategy during the forward momentum generation required for successful STS performance.
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Baseline (T0), immediately after completion of the 4-week intervention (T1), and 12 weeks after the end of the intervention (T2).
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Estimated anterior-posterior center of mass displacement during STS
Lasso di tempo: Baseline (T0), immediately after completion of the 4-week intervention (T1), and 12 weeks after the end of the intervention (T2).
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Estimated anterior-posterior CoM displacement during the STS task will be obtained using the PhysioMaster smartphone-based inertial measurement system.
Raw IMU data will be exported to MATLAB for signal processing, including low-pass filtering at 5 Hz.
The application estimates anterior-posterior CoM displacement (mm) from trunk inclination measured by the IMU using sensor-fusion algorithms and a simplified biomechanical model.
Changes in estimated anterior-posterior CoM displacement will be interpreted together with STS duration and peak trunk angular velocity to characterize forward weight transfer and movement strategy during the STS task.
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Baseline (T0), immediately after completion of the 4-week intervention (T1), and 12 weeks after the end of the intervention (T2).
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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User satisfaction with immersive virtual reality
Lasso di tempo: After completion of the 4-week intervention (T1)
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Participant satisfaction with the immersive virtual reality intervention will be assessed using the User Satisfaction Evaluation Questionnaire (USEQ).
The USEQ is a 6-item instrument specifically designed to evaluate user satisfaction with virtual rehabilitation systems.
Items assess enjoyment, perceived success, system control, clarity of information, comfort, and perceived rehabilitation benefit using a 5-point Likert scale ranging from 1 (not at all) to 5 (very much).
Total scores range from 6 to 30 points, with higher scores indicating greater satisfaction with the virtual reality intervention.
Scores ≥25 indicate high satisfaction, scores between 15 and 24 indicate moderate satisfaction, and scores <15 indicate low satisfaction.
This outcome will be assessed only in participants allocated to the IVR group.
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After completion of the 4-week intervention (T1)
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 gennaio 2027
Completamento primario (Stimato)
1 febbraio 2028
Completamento dello studio (Stimato)
1 aprile 2028
Date di iscrizione allo studio
Primo inviato
7 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
16 luglio 2026
Primo Inserito (Effettivo)
20 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
20 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
16 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CEI_25_214_S56_R
- Not Applicable (N/A) (Altro identificatore: Not Applicable (N/A))
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .