StrokeNCT07713446
Effects of Task-Oriented Sit-to-Stand Training Using Immersive VR and PNF on Quality of Life in Chronic Stroke: Trial Protocol
A study testing Immersive Virtual Reality group, Proprioceptive Neuromuscular Facilitation group and Conventional therapy group in people with Stroke and Cerebrovascular Accident (Stroke), run by Universidad Nacional Autonoma de Mexico at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 71 years
- Conditions the study is for
- Stroke, Cerebrovascular Accident (Stroke)
- What is being tested?
- Immersive Virtual Reality group, Proprioceptive Neuromuscular Facilitation group and Conventional therapy group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2027to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Escuela Nacional de Estudios Superiores, Unidad León
León, Guanajuato, 37689
Carlos R Palma Reyes, Master's Degree, +52 477194 0800, cpalma@enes.unam.mx
About this study
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
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)
- Being tested
- Immersive Virtual Reality group, Proprioceptive Neuromuscular Facilitation group, Conventional therapy group
- Keywords
- stroke, Propioceptive Neuromuscular Facilitation, PNF, Immersive Virtual Reality, Sit to Stand
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual Reality groupDevice
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.
Proprioceptive Neuromuscular Facilitation groupOther
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.
Conventional therapy groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Other: Conventional therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline (T0), immediately after completion of the 4-week intervention (T1), and 12 weeks after the end of the intervention (T2).
Estimated anterior-posterior center of mass displacement during STS
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.
Measured: Baseline (T0), immediately after completion of the 4-week intervention (T1), and 12 weeks after the end of the intervention (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study startJan 2027 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Autonoma de Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cadiz
- Responsible party
- Principal investigator, Carlos Rafael Palma Reyes, Universidad Nacional Autonoma de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713446
- Sponsor's protocol ID
- CEI_25_214_S56_R
- Other IDs
- Not Applicable (N/A)
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07713446
- Acronym / sponsor ID
- CEI_25_214_S56_R
- Conditions
- Stroke, Cerebrovascular Accident (Stroke)
- Keywords
- stroke, Propioceptive Neuromuscular Facilitation, PNF, Immersive Virtual Reality, Sit to Stand
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Universidad Nacional Autonoma de MexicoUniversity, hospital or other
- Collaborators
- University of Cadiz
- Study start
- Jan 2027 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immersive Virtual Reality Group (IVR-G) | Experimental | Device: Immersive Virtual Reality group, Other: Conventional therapy groupParticipants 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). |
| Proprioceptive Neuromuscular Facilitation Group (PNF-G) | Experimental | Other: Proprioceptive Neuromuscular Facilitation group, Other: Conventional therapy groupParticipants 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). |
| Convetional Therapy | Active comparator | Other: Conventional therapy groupParticipants 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). |
Who may qualify
- Ages
- 35 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive Virtual Reality groupParticipants 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. | Device | Immersive Virtual Reality Group (IVR-G) |
| Proprioceptive Neuromuscular Facilitation groupParticipants 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 | Proprioceptive Neuromuscular Facilitation Group (PNF-G) |
| Conventional therapy groupParticipants 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. | Other | Convetional Therapy, Immersive Virtual Reality Group (IVR-G), Proprioceptive Neuromuscular Facilitation Group (PNF-G) |
Primary outcome
Quality of Life Measure
Time frame: Baseline (T0), immediately after completion of the 4-week intervention (T1), and 12 weeks after the end of the intervention (T2).
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.
6 secondary outcomes
Sit-to-Stand duration
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline (T0), immediately after completion of the 4-week intervention (T1), and 12 weeks after the end of the intervention (T2).
Estimated anterior-posterior center of mass displacement during STS
Time frame: Baseline (T0), immediately after completion of the 4-week intervention (T1), and 12 weeks after the end of the intervention (T2).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual Reality group, Proprioceptive Neuromuscular Facilitation group and Conventional therapy group in people with Stroke and Cerebrovascular Accident (Stroke), run by Universidad Nacional Autonoma de Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carlos R Palma Reyes, Master's Degree (+52 477 194 0800, cpalma@enes.unam.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Measure (time frame: Baseline (T0), immediately after completion of the 4-week intervention (T1), and 12 weeks after the end of the intervention (T2).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.