StrokeNCT07629791
Effects of Augmented Reality (AR) and Transcranial Direct Current Stimulation (tDCS)
A study testing Augmented reality combined with tDCS & Convention therapy in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this randomized controlled trial is to determine the effects of Augmented Reality (AR)-based balance training on improving balance and postural control in chronic stroke survivors and whether the addition of transcranial Direct Current Stimulation (tDCS) to AR training produces superior outcomes compared to… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- Augmented reality combined with tDCS & Convention therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 20 May 2026to 20 Nov 2026
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Balance impairment confirmed by Berg Balance Scale (BBS) score 21-44.
- Age between 18-90 years.
- Mild or no spasticity in lower limb (MAS ≤ 2)
- have sufficient cognition to follow the instructions provided by the therapists and the computer.
Who cannot join
- Individuals with implanted electronic devices (e.g., pacemakers), due to interaction risk with tDCS
- Other medical or psychological conditions affecting participation (e.g., severe pain, epilepsy, pacemaker).
- Patients with severe cognitive deficits or visual impairments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Railway General Hospital
Rawalpindi, Punjab Province, 44000
Abrish Habib Abbasi, PhD* Rehab, 03155311799, abrish.habib@riphah.edu.pk
Arshad Nawaz Malik, PhD Rehab
About this study
Official title: Effects of Augmented Reality (AR) and Transcranial Direct Current Stimulation (tDCS) on Balance and Postural Control in Chronic Stroke Survivors
The aim of this randomized controlled trial is to determine the effects of Augmented Reality (AR)-based balance training on improving balance and postural control in chronic stroke survivors and whether the addition of transcranial Direct Current Stimulation (tDCS) to AR training produces superior outcomes compared to AR training alone.
Read the detailed description
Stroke remains one of the leading causes of death and long-term disability worldwide, with survivors often experiencing persistent motor and sensory impairments that significantly impact their quality of life. In 2020, it caused about 6.6 million deaths and ranked third for disability-adjusted life-years (DALYs) lost, with the burden rising fastest in low- and middle-income countries. Even after surviving a stroke, many people up to 83% continue to have problems with balance and controlling their posture. These difficulties make daily activities harder, increase the chance of falling, and lower their quality of life.
Balance and postural control are important because they help us stay steady and move safely. After a stroke, these abilities often get damaged because the brain areas that control movement and coordination are affected. People who have had a stroke may walk slower, sway more when standing, and have trouble with tasks like standing up or turning around. Balance impairments manifest as altered body weight distribution patterns, reduced weight-bearing capacity through the affected limb, and diminished postural stability, leading to increased fall risk and decreased participation in activities of daily living. In fact, only a small number of stroke survivors can walk freely without help, and many experiences falls more often than people without stroke. Stroke survivors fall more than twice as often as healthy controls, with balance impairments leading to decreased participation in activities of daily living, fear of falling, and social isolation. Augmented Reality (AR) technology has emerged as a promising intervention for stroke rehabilitation. AR systems provide immersive and interactive virtual environments that can enhance motor rehabilitation through collaborative stimulation of multiple sensory channels, including visual, auditory, and proprioceptive feedback. This multimodal approach facilitates repetitive practice with real-time feedback and encouragement, potentially enhancing rehabilitation effectiveness through increased engagement and motivation. Recent systematic reviews and meta-analyses have demonstrated that AR-based interventions can significantly improve both upper and lower limb function in stroke patients.
Studies have shown that AR training leads to improvements in obstacle avoidance, balance performance, and functional mobility compared to conventional rehabilitation alone. The technology's ability to provide personalized, adaptive training environments allows for customization based on individual patient needs and capabilities, potentially optimizing therapeutic outcomes. The integration of AR with traditional rehabilitation methods has shown particular promise, with combined approaches yielding better functional outcomes than either intervention alone.
Transcranial direct current stimulation (tDCS) represents a non-invasive neuromodulation technique that has gained considerable attention in stroke rehabilitation for its ability to modify cortical excitability and potentially enhance neuroplasticity. By delivering low-intensity electrical current through scalp electrodes, tDCS can modulate neuronal activity in targeted brain regions, with anodal stimulation typically increasing cortical excitability and cathodal stimulation having inhibitory effects. Research has demonstrated that tDCS can improve various aspects of motor function in stroke patients, including balance and postural control. Studies have shown immediate and sustained effects of tDCS on balance parameters, with improvements in weight-bearing distribution, postural stability, and functional mobility measures.
Cerebellar tDCS, in particular, has shown superior effects compared to cerebral stimulation for improving balance and gait function in chronic stroke patients. The mechanisms underlying tDCS effects involve modulation of cortical and spinal neuronal circuits involved in movement control. Meta-analyses have indicated that tDCS can provide significant benefits for balance outcomes in stroke patients, although the quality of evidence remains variable and further research is needed to optimize stimulation parameters and patient selection criteria.
The concept for combining Augmented Reality (AR) and transcranial Direct Current Stimulation (tDCS) in stroke rehabilitation is grounded in the principles of neuroplasticity, which refers to the brain's capacity to reorganize and form new neural connections following injury. AR provides enriched, task-specific sensory environments that facilitate intensive motor practice, while tDCS modulates cortical excitability to enhance synaptic plasticity. Together, these interventions may produce synergistic effects by optimizing neural reorganization and functional recovery. Although both modalities have demonstrated individual efficacy in improving balance and postural control post-stroke, their combined therapeutic potential remains underexplored, highlighting the need for further research to advance multimodal rehabilitation strategies.
- Conditions
- Stroke
- Being tested
- Augmented reality combined with tDCS & Convention therapy, Augmented reality combined with Sham & Convention therapy
- Keywords
- Stroke rehabilitation, Balance training, Postural control, Augmented reality, Transcranial Direct Current Stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented reality combined with tDCS & Convention therapyOther
Participants will receive 12 sessions over 4 weeks (3 sessions per week), each lasting 60 minutes. Transcranial Direct Current Stimulation (tDCS) will be applied for 15 minutes immediately before the AR balance training session. Each session will consist of 30 minutes of interactive AR-based balance games with real-time visual and auditory feedback, followed by 15 minutes of conventional therapy targeting balance and mobility. All sessions will be supervised by a physiotherapist, and participants' queries during the training will be addressed.
Augmented reality combined with Sham & Convention therapyOther
The participants in this group will undergo 12 sessions over 4 weeks (3 sessions per week), with each session lasting 60 minutes, consisting of 30 minutes of interactive balance tasks through AR-based games with real-time visual and auditory feedback, 15 minutes of conventional physiotherapy-based balance and mobility training, and 15 minutes of sham stimulation using the tDCS setup without active current flow.
| Study group | Role | What they receive |
|---|---|---|
| Augmented reality Combined with TDCs + Convention therapy | Experimental | Participants will receive 12 sessions over 4 weeks (3 sessions per week), each lasting 60 minutes. Transcranial Direct Current Stimulation (tDCS) will be applied for 15 minutes immediately before the AR balance training session. Each session will consist of 30 minutes of interactive AR-based balance games with real-time visual and auditory feedback, followed by 15 minutes of conventional therapy targeting balance and mobility. All sessions will be supervised by a physiotherapist, and participants' queries during the training will be addressed. Receives: Other: Augmented reality combined with tDCS & Convention therapy |
| Augmented reality with Sham+ Convention therapy | Active comparator | The Control group will undergo 12 sessions over 4 weeks (3 sessions per week), with each session lasting 60 minutes, consisting of 30 minutes of interactive balance tasks through AR-based games with real-time visual and auditory feedback, 15 minutes of conventional physiotherapy-based balance and mobility training, and 15 minutes of sham stimulation using the tDCS setup without active current flow. Receives: Other: Augmented reality combined with Sham & Convention therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale (BBS)
Berg Balance Scale is a performance-based measure used to assess static and dynamic balance abilities in stroke survivors. It consists of 14 functional tasks such as standing, reaching, turning, and transfers, performed under supervision.
Scoring: Each item is rated on a 5-point ordinal scale (0-4), where 0 = unable to perform and 4 = performs independently. The maximum score is 56 points.
Interpretation:
- 0-20 = High risk of falls
- 21-40 = Moderate risk of falls
- 41-56 = Low risk of falls
Measured: Baseline-4 Weeks-8 Week-1 Month Follow Up
Timed Up and Go Test (TUG)
The Timed Up and Go test measures basic functional mobility and is a quick, simple tool to evaluate fall risk and dynamic balance. Participants are asked to stand up from a chair, walk 3 meters, turn around, walk back, and sit down.
Scoring: The time (in seconds) taken to complete the task is recorded.
- <10 seconds = Completely mobile
- <20 seconds = Mostly independent
- 20-29 seconds = Variable mobility
- ≥30 seconds = Impaired walking, high fall risk
Measured: Baseline-4 Weeks-8 Week-1 Month Follow Up
Postural Assessment Scale for Stroke (PASS)
The Postural Assessment Scale for Stroke (PASS) is a clinical tool specifically designed to assess postural control in stroke patients. It consists of 12 items divided into two sections: Maintaining Posture (sitting, standing, lying) and Changing Posture (transfers, standing up, picking objects).
Scoring: Each item is scored on a scale of 0-3, with a total maximum score of 36 points.
- Higher scores = Better postural control
- Lower scores = Higher risk of falls and dependence in mobility
Measured: Baseline-4 Weeks-8 Week-1 Month Follow Up
Functional Reach Test
Predicts fall risk by measuring dynamic trunk reach. Normal value = 22.7 cm. ICC = 0.80-0.88 Inter-Class = 0.94-0.97 Test-retest = 0.84-0.86 (p<0.001)
Measured: Baseline-4 Weeks-8 Week-1 Month Follow Up
Fugl-Meyer Assessment (FMA) (LE)
Evaluates lower extremity motor recovery post-stroke, including reflexes, voluntary movement, and coordination.
Measured: Baseline-4 Weeks-8 Week-1 Month Follow Up
Activities-specific Balance Confidence (ABC) Scale
Assesses confidence in performing ambulatory activities. 16-item self-report questionnaire. Test-retest ICC = 0.91
Measured: Baseline-4 Weeks-8 Week-1 Month Follow Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start20 May 2026
- Primary completion20 Oct 2026 (estimated)
- Study completion20 Nov 2026 (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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aaleen Fatima, MS-NMPT*, Principal investigator, Riphah International Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629791
- Sponsor's protocol ID
- 02264/ Aaleen Fatima
- Status last verified
- Jul 2026
- First submitted
- 1 Jun 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 Augmented Reality (AR) and Transcranial Direct Current Stimulation (tDCS) on Balance and Postural Control in Chronic Stroke Survivors
- ClinicalTrials.gov ID
- NCT07629791
- Acronym / sponsor ID
- 02264/ Aaleen Fatima
- Conditions
- Stroke
- Keywords
- Stroke rehabilitation, Balance training, Postural control, Augmented reality, Transcranial Direct Current Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 May 2026 (actual)
- Primary completion
- 20 Oct 2026 (estimated)
- Study completion
- 20 Nov 2026 (estimated)
- First posted
- 5 Jun 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 aim of this randomized controlled trial is to determine the effects of Augmented Reality (AR)-based balance training on improving balance and postural control in chronic stroke survivors and whether the addition of transcranial Direct Current Stimulation (tDCS) to AR training produces superior outcomes compared to AR training alone.
Detailed description
Stroke remains one of the leading causes of death and long-term disability worldwide, with survivors often experiencing persistent motor and sensory impairments that significantly impact their quality of life. In 2020, it caused about 6.6 million deaths and ranked third for disability-adjusted life-years (DALYs) lost, with the burden rising fastest in low- and middle-income countries. Even after surviving a stroke, many people up to 83% continue to have problems with balance and controlling their posture. These difficulties make daily activities harder, increase the chance of falling, and lower their quality of life.
Balance and postural control are important because they help us stay steady and move safely. After a stroke, these abilities often get damaged because the brain areas that control movement and coordination are affected. People who have had a stroke may walk slower, sway more when standing, and have trouble with tasks like standing up or turning around. Balance impairments manifest as altered body weight distribution patterns, reduced weight-bearing capacity through the affected limb, and diminished postural stability, leading to increased fall risk and decreased participation in activities of daily living. In fact, only a small number of stroke survivors can walk freely without help, and many experiences falls more often than people without stroke. Stroke survivors fall more than twice as often as healthy controls, with balance impairments leading to decreased participation in activities of daily living, fear of falling, and social isolation. Augmented Reality (AR) technology has emerged as a promising intervention for stroke rehabilitation. AR systems provide immersive and interactive virtual environments that can enhance motor rehabilitation through collaborative stimulation of multiple sensory channels, including visual, auditory, and proprioceptive feedback. This multimodal approach facilitates repetitive practice with real-time feedback and encouragement, potentially enhancing rehabilitation effectiveness through increased engagement and motivation. Recent systematic reviews and meta-analyses have demonstrated that AR-based interventions can significantly improve both upper and lower limb function in stroke patients.
Studies have shown that AR training leads to improvements in obstacle avoidance, balance performance, and functional mobility compared to conventional rehabilitation alone. The technology's ability to provide personalized, adaptive training environments allows for customization based on individual patient needs and capabilities, potentially optimizing therapeutic outcomes. The integration of AR with traditional rehabilitation methods has shown particular promise, with combined approaches yielding better functional outcomes than either intervention alone.
Transcranial direct current stimulation (tDCS) represents a non-invasive neuromodulation technique that has gained considerable attention in stroke rehabilitation for its ability to modify cortical excitability and potentially enhance neuroplasticity. By delivering low-intensity electrical current through scalp electrodes, tDCS can modulate neuronal activity in targeted brain regions, with anodal stimulation typically increasing cortical excitability and cathodal stimulation having inhibitory effects. Research has demonstrated that tDCS can improve various aspects of motor function in stroke patients, including balance and postural control. Studies have shown immediate and sustained effects of tDCS on balance parameters, with improvements in weight-bearing distribution, postural stability, and functional mobility measures.
Cerebellar tDCS, in particular, has shown superior effects compared to cerebral stimulation for improving balance and gait function in chronic stroke patients. The mechanisms underlying tDCS effects involve modulation of cortical and spinal neuronal circuits involved in movement control. Meta-analyses have indicated that tDCS can provide significant benefits for balance outcomes in stroke patients, although the quality of evidence remains variable and further research is needed to optimize stimulation parameters and patient selection criteria.
The concept for combining Augmented Reality (AR) and transcranial Direct Current Stimulation (tDCS) in stroke rehabilitation is grounded in the principles of neuroplasticity, which refers to the brain's capacity to reorganize and form new neural connections following injury. AR provides enriched, task-specific sensory environments that facilitate intensive motor practice, while tDCS modulates cortical excitability to enhance synaptic plasticity. Together, these interventions may produce synergistic effects by optimizing neural reorganization and functional recovery. Although both modalities have demonstrated individual efficacy in improving balance and postural control post-stroke, their combined therapeutic potential remains underexplored, highlighting the need for further research to advance multimodal rehabilitation strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Augmented reality Combined with TDCs + Convention therapy | Experimental | Other: Augmented reality combined with tDCS & Convention therapyParticipants will receive 12 sessions over 4 weeks (3 sessions per week), each lasting 60 minutes. Transcranial Direct Current Stimulation (tDCS) will be applied for 15 minutes immediately before the AR balance training session. Each session will consist of 30 minutes of interactive AR-based balance games with real-time visual and auditory feedback, followed by 15 minutes of conventional therapy targeting balance and mobility. All sessions will be supervised by a physiotherapist, and participants' queries during the training will be addressed. |
| Augmented reality with Sham+ Convention therapy | Active comparator | Other: Augmented reality combined with Sham & Convention therapyThe Control group will undergo 12 sessions over 4 weeks (3 sessions per week), with each session lasting 60 minutes, consisting of 30 minutes of interactive balance tasks through AR-based games with real-time visual and auditory feedback, 15 minutes of conventional physiotherapy-based balance and mobility training, and 15 minutes of sham stimulation using the tDCS setup without active current flow. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Balance impairment confirmed by Berg Balance Scale (BBS) score 21-44.
- Age between 18-90 years.
- Mild or no spasticity in lower limb (MAS ≤ 2)
- have sufficient cognition to follow the instructions provided by the therapists and the computer.
Key exclusion criteria (3 listed)
- Individuals with implanted electronic devices (e.g., pacemakers), due to interaction risk with tDCS
- Other medical or psychological conditions affecting participation (e.g., severe pain, epilepsy, pacemaker).
- Patients with severe cognitive deficits or visual impairments
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 |
|---|---|---|
| Augmented reality combined with tDCS & Convention therapyParticipants will receive 12 sessions over 4 weeks (3 sessions per week), each lasting 60 minutes. Transcranial Direct Current Stimulation (tDCS) will be applied for 15 minutes immediately before the AR balance training session. Each session will consist of 30 minutes of interactive AR-based balance games with real-time visual and auditory feedback, followed by 15 minutes of conventional therapy targeting balance and mobility. All sessions will be supervised by a physiotherapist, and participants' queries during the training will be addressed. | Other | Augmented reality Combined with TDCs + Convention therapy |
| Augmented reality combined with Sham & Convention therapyThe participants in this group will undergo 12 sessions over 4 weeks (3 sessions per week), with each session lasting 60 minutes, consisting of 30 minutes of interactive balance tasks through AR-based games with real-time visual and auditory feedback, 15 minutes of conventional physiotherapy-based balance and mobility training, and 15 minutes of sham stimulation using the tDCS setup without active current flow. | Other | Augmented reality with Sham+ Convention therapy |
Primary outcome
Berg Balance Scale (BBS)
Time frame: Baseline-4 Weeks-8 Week-1 Month Follow Up
Berg Balance Scale is a performance-based measure used to assess static and dynamic balance abilities in stroke survivors. It consists of 14 functional tasks such as standing, reaching, turning, and transfers, performed under supervision. Scoring: Each item is rated on a 5-point ordinal scale (0-4), where 0 = unable to perform and 4 = performs independently. The maximum score is 56 points. Interpretation: * 0-20 = High risk of falls * 21-40 = Moderate risk of falls * 41-56 = Low risk of falls
Timed Up and Go Test (TUG)
Time frame: Baseline-4 Weeks-8 Week-1 Month Follow Up
The Timed Up and Go test measures basic functional mobility and is a quick, simple tool to evaluate fall risk and dynamic balance. Participants are asked to stand up from a chair, walk 3 meters, turn around, walk back, and sit down. Scoring: The time (in seconds) taken to complete the task is recorded. * <10 seconds = Completely mobile * <20 seconds = Mostly independent * 20-29 seconds = Variable mobility * ≥30 seconds = Impaired walking, high fall risk
Postural Assessment Scale for Stroke (PASS)
Time frame: Baseline-4 Weeks-8 Week-1 Month Follow Up
The Postural Assessment Scale for Stroke (PASS) is a clinical tool specifically designed to assess postural control in stroke patients. It consists of 12 items divided into two sections: Maintaining Posture (sitting, standing, lying) and Changing Posture (transfers, standing up, picking objects). Scoring: Each item is scored on a scale of 0-3, with a total maximum score of 36 points. * Higher scores = Better postural control * Lower scores = Higher risk of falls and dependence in mobility
Functional Reach Test
Time frame: Baseline-4 Weeks-8 Week-1 Month Follow Up
Predicts fall risk by measuring dynamic trunk reach. Normal value = 22.7 cm. ICC = 0.80-0.88 Inter-Class = 0.94-0.97 Test-retest = 0.84-0.86 (p<0.001)
Fugl-Meyer Assessment (FMA) (LE)
Time frame: Baseline-4 Weeks-8 Week-1 Month Follow Up
Evaluates lower extremity motor recovery post-stroke, including reflexes, voluntary movement, and coordination.
Activities-specific Balance Confidence (ABC) Scale
Time frame: Baseline-4 Weeks-8 Week-1 Month Follow Up
Assesses confidence in performing ambulatory activities. 16-item self-report questionnaire. Test-retest ICC = 0.91
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.
Aaleen Fatima, MS-NMPT* principal investigator
Riphah International Unversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented reality combined with tDCS & Convention therapy in people with Stroke, run by Riphah International University at 1 site in Pakistan.
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 4 inclusion and 3 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: looking for participants now, 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 Pakistan. 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 Abrish H Abbasi (03155311799, abrish.habib@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (BBS) (time frame: Baseline-4 Weeks-8 Week-1 Month Follow Up). The study lists 6 primary outcomes in all. 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.