Parkinson DiseaseNCT06104072
Effect of Adding Computerized Cognitive Training on Balance, Locomotion and Cognition in Parkinson's Disease
A study testing REHACOM Software and A Designed Physical Therapy Program in people with Parkinson Disease, run by Engy Badreldin Saleh Moustafa, PhD at 1 site in Egypt.
Trial summary
BACKGROUND: Postural instability and gait abnormalities are cardinal features in Parkinson's disease (PD). It represents one of the most disabling symptoms in the advanced stages of the disease. Read more about this study
- Who is it for?
- Ages 58 to 70 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- REHACOM Software and A Designed Physical Therapy Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 23 May 2024to 20 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 58 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Egyptian Parkinson's Disease patients of both sex , all patients fulfilled the U.K Parkinson's Disease Brain Bank Criteria for diagnosis of idiopathic PD.
- The patients' age ranged from 58 to 68 years.
- The duration of illness ranged from two to five years.
- The severity of the disease ranged from mild to moderate disability according to UPDRS motor scores (part III) and Modified Hoehn and Yahr staging (stage 2.5\&3) .
- Cognitive function ranged from 65 to 81 according to Parkinson's Disease-Cognitive Rating Scale (PD-CRS) that indicates mild cognitive impairment.
- The patients with mild balance and gait impairments
- Medically and psychologically stable patients and of adequate cardiac function to adhere to the protocol.
Who cannot join
- Patients with secondary parkinsonism (Drug-induced, post traumatic, or post infectious) or atypical parkinsonism.
- Patients with major language disturbance, severe physical, auditory or visual impairment affecting their ability to complete testing.
- Patients with magnetic devices or any other implanted device (e.g., metallic implants such as pacemakers, surgical aneurysm clips…etc).
- Patients with a history of seizure, head injury or brain surgery.
- Complicating or unstable cardiovascular disease (unstable angina, recent myocardial infarction within the last three months, congestive heart failure, significant heart valve dysfunction, or unstable hypertension) or pulmonary disorders.
- Patients with musculoskeletal disorders such as severe arthritis, knee surgery, total hip joint replacement, lower limb fractures or contractures of fixed deformity.
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- Patients with evidence from the history, physical examination, or special investigations for any concomitant medical or metabolic illness known to affect cognition e.g. cerebrovascular stroke, thyroid or parathyroid disease, hepatic or renal failure.
- Patients receiving certain drugs known to improve cognition (e.g. rivastigmine, memantine…..etc).
- Patients with current or prior history of major psychiatric disorder and/or current use of anxiolytic, neuroleptic, sedative medication or sleeping aids.
- Uncooperative patients.
- Illiterate patients.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy, Cairo University
Giza, Giza Governorate, 11432
Engy B Saleh, PhD, 00201099445112, engybm.saleh@yahoo.com
Moshera H. Darwish, PhD, 00201015163617, dr.moshera11@yahoo.com
About this study
Official title: Adding Computer-based Cognitive Training to Conventional Rehabilitation Can Affect Postural Stability , Locomotion and Cognition in Parkinson's Disease Patients
BACKGROUND: Postural instability and gait abnormalities are cardinal features in Parkinson's disease (PD). It represents one of the most disabling symptoms in the advanced stages of the disease.
The purpose of this study was to evaluate the immediate and long-term effects of adding computer-based cognitive training to physical therapy interventions on postural stability, locomotion, and cognitive performance in Parkinson's disease patients.
Read the detailed description
Study design: A randomized control clinical trial among sixty-eight Egyptian Parkinson's Disease patients of both sexes participated in the study; their ages ranged from 55 to 70 years. They were selected from the Neurology Clinics and from the Movement Disorder Clinic, Neurology Department, Faculty of Medicine, Cairo University, in the period from May 2024 to March 2025.
The patients will be divided into two equal groups: the control group (GA) and the study group (GB). Patients in GA will be treated by a designed physiotherapy program consisting of aerobic exercise on a treadmill, stretching exercises, proprioceptive neuromuscular facilitation (PNF) techniques, graduated active exercises, gait training, reciprocal, and weight-shifting exercises for 60 minutes. Patients in (GB) will be treated with computer-based cognitive training using REHACOM (30 minutes) in addition to the same physiotherapy program as GA (30 minutes). Rehacom software will be used for cognitive training targeting four main cognitive domains; attention/concentration, figural memory, auditory response control, and visual response control. . The treatment session for all patients in both groups will be 60minutes/session. The whole treatment protocol will include 24 sessions, three sessions per week, for two successive months.
Primary Outcomes:
- Postural stability:
- Biodex balance system was used to assess dynamic balance indices ( Overall stability index, mediolateral stability \& anteroposterior stability)
- Spatio-temporal gait parameters:
- Digital video camera and kinovea (video motion analysis software) was used to assess spatiotemporal gait parameters (Stride length, velocity \& Cadence).
Secondary Outcome:
- Overall cognitive functions:
- Parkinson's Disease - Cognitive Rating Scale (PD-CRS).
- Conditions
- Parkinson Disease
- Being tested
- REHACOM Software, A Designed Physical Therapy Program
- Keywords
- Computer-Based Cognitive training, Parkinsonian Disease, Postural Stability, Gait
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REHACOM SoftwareDevice
Also called Computer-Based Cognitive Training
It is a computer-based cognitive rehabilitation test that includes 32 cognition training tasks for attention/concentration, reaction behavior, memory , logical reasoning \& executive functioning with graded difficulty . It is composed of regular PC , 1G RAM , DVD drive, 100 GB hard drive with windows XP SP3, 128 MB RAM direct 3D graphic card , Screen at least 19" , regular PC keyboard or Rehacom panel \& printer .The Rehacom software version is (patientenpult (1990-1997) EN/ISO-13485-certified).
- For each Cognitive training domain there is one hundred levels of difficulty.
- Each patient is evaluated from level one(1) ang gradually increase the difficulty till we reach the level that will be used in the treatment sessions as the patient's performance improve we can proceed to the next level.
- The period of the session was chosen to be maximum (60 minutes) for each patient with five minutes rest in between each level.
A Designed Physical Therapy ProgramOther
A designed physiotherapy program consisted of aerobic exercise on treadmill, stretching exercise, Proprioceptive neuromuscular facilitation (PNF) techniques, Graduated active exercises, postural correction, gait training, balance training on different base of supports using static and dynamic balance training with reciprocal and weight shifting exercises.
| Study group | Role | What they receive |
|---|---|---|
| Control group (GA) | Placebo comparator | Patients in control group (GA) will be treated by a designed physiotherapy program consisted of aerobic exercise on treadmill, stretching exercise, Proprioceptive neuromuscular facilitation (PNF) techniques, Graduated active exercises, gait training, Reciprocal and weight shifting exercises for 60 minutes/session, 3 days/week for 8 consecutive weeks Receives: Other: A Designed Physical Therapy Program |
| Study group (GB) | Experimental | Patients in (GB) will be treated by computer-based cognitive training for 30 minutes followed by the same physiotherapy program as GA for another 30 minutes. so the whole duration of the treatment session for (GB) is 60 minutes ( half of the session the computerized cognitive training and the other half is for the designed physical therapy program). the whole treatment intervention will be 3 days /week for 8 consecutive weeks. Receives: Device: REHACOM Software; Other: A Designed Physical Therapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Stability Index
- Overall balance index: represents the patient's ability to control balance in all directions. High values indicate balance disturbance (increase rate of body swaying during the test).
Measured: Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up)
Anterior / posterior (A/P) index
- Anterior / posterior (A/P) index represents the patient's ability to control balance in front to back direction.
Measured: Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up)
Medial/ lateral (M/L) index
- Medial/ lateral (M/L) index: represents the patient's ability to maintain balance from side to side.
Measured: Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up)
Velocity of Gait
Using 2D motion analysis in Kinovea program for spatiotemporal gait analysis
- Velocity = Distance/Time
- The total distance: represented by the actual length that the patient walked and this was presented by the blue line (three meters).
- The total duration of walking (seconds): was calculated by using the ''stop watch'' tool in kinovea program. Velocity meter/seconds: was calculated by dividing the total distance that had been walked by the patient over the total duration.
Measured: Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up)
Cadence of Gait
Using 2D motion analysis in Kinovea program for spatiotemporal gait analysis Cadence is the Number of steps/Minute
- Number of steps: calculated by counting the steps the patient walked from the beginning to the end of the walkway (blue line).
- Cadence was calculated by dividing the number of steps that the patient walked over the actual duration of walking.
Measured: Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up)
Stride Length
Using 2D motion analysis in Kinovea program, stride length was the distance from the first initial contact of one foot (1st frame) to the next initial contact of the ipsilateral foot (2nd frame).
Measured: Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up)
Secondary outcomes (1)
Overall cognitive performance
- Parkinson's Disease - Cognitive Rating Scale (PD-CRS) was conducted for each patient from a comfortable sitting position on a chair with back support and suitable seat height compared to a table in front of the patient.
- The following cognitive domains were assessed: - Immediate free recall verbal memory (12 points), Confrontation naming (20 points), - Sustained attention (ten points), Working memory (ten points), - Visuo-constructional skills (Unprompted drawing of a clock) (ten points), Visuo-perceptual skills (Copy drawing of a clock) (ten points), - Delayed free recall verbal memory (12 points),Alternating verbal fluency (20 points) and - Action verbal fluency (30 points).
The overall total score for the (PD-CRS) is 134, the lower the score the more the cognitive impairment. The inclusion criteria for PD patients with cognitive decline indicated that a score 65-84 was the optimal cutoff point on the total score for the PD-CRS indicating mild cognitive impairment.
Measured: Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start23 May 2024
- Primary completion13 Feb 2025
- Study completion20 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Randomized Controlled Clinical trial, where the recruited patients will be randomly assigned into 2 equal groups ( GA \& GB) using sealed envelopes. control group (GA) and study group (GB). Patients in (GA) will be treated by a designed physiotherapy program consisted of aerobic exercise on treadmill, stretching exercise, Proprioceptive neuromuscular facilitation (PNF) techniques, Graduated active exercises, gait training, Reciprocal and weight shifting exercises for 60 minutes/session. Patients in (GB) will be treated by computer-based cognitive training (30 minutes) in addition to the same physiotherapy program as GA (30 minutes).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Engy Badreldin Saleh Moustafa, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Engy Badreldin Saleh Moustafa, PhD, Cairo University
- Investigators
- Engy B Saleh, PhD, Principal investigator, Faculty of Physical Therapy, Cairo University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104072
- Sponsor's protocol ID
- P.T.REC/012/004746
- Status last verified
- Apr 2024
- First submitted
- 20 Oct 2023
- Last updated
- 9 Apr 2025
- 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 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adding Computer-based Cognitive Training to Conventional Rehabilitation Can Affect Postural Stability , Locomotion and Cognition in Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT06104072
- Acronym / sponsor ID
- P.T.REC/012/004746
- Conditions
- Parkinson Disease
- Keywords
- Computer-Based Cognitive training, Parkinsonian Disease, Postural Stability, Gait
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Engy Badreldin Saleh Moustafa, PhDUniversity, hospital or other
- Study start
- 23 May 2024 (actual)
- Primary completion
- 13 Feb 2025 (actual)
- Study completion
- 20 Apr 2025 (estimated)
- First posted
- 27 Oct 2023 (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.
BACKGROUND: Postural instability and gait abnormalities are cardinal features in Parkinson's disease (PD). It represents one of the most disabling symptoms in the advanced stages of the disease.
The purpose of this study was to evaluate the immediate and long-term effects of adding computer-based cognitive training to physical therapy interventions on postural stability, locomotion, and cognitive performance in Parkinson's disease patients.
Detailed description
Study design: A randomized control clinical trial among sixty-eight Egyptian Parkinson's Disease patients of both sexes participated in the study; their ages ranged from 55 to 70 years. They were selected from the Neurology Clinics and from the Movement Disorder Clinic, Neurology Department, Faculty of Medicine, Cairo University, in the period from May 2024 to March 2025.
The patients will be divided into two equal groups: the control group (GA) and the study group (GB). Patients in GA will be treated by a designed physiotherapy program consisting of aerobic exercise on a treadmill, stretching exercises, proprioceptive neuromuscular facilitation (PNF) techniques, graduated active exercises, gait training, reciprocal, and weight-shifting exercises for 60 minutes. Patients in (GB) will be treated with computer-based cognitive training using REHACOM (30 minutes) in addition to the same physiotherapy program as GA (30 minutes). Rehacom software will be used for cognitive training targeting four main cognitive domains; attention/concentration, figural memory, auditory response control, and visual response control. . The treatment session for all patients in both groups will be 60minutes/session. The whole treatment protocol will include 24 sessions, three sessions per week, for two successive months.
Primary Outcomes:
- Postural stability:
- Biodex balance system was used to assess dynamic balance indices ( Overall stability index, mediolateral stability \& anteroposterior stability)
- Spatio-temporal gait parameters:
- Digital video camera and kinovea (video motion analysis software) was used to assess spatiotemporal gait parameters (Stride length, velocity \& Cadence).
Secondary Outcome:
- Overall cognitive functions:
- Parkinson's Disease - Cognitive Rating Scale (PD-CRS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Clinical trial, where the recruited patients will be randomly assigned into 2 equal groups ( GA \& GB) using sealed envelopes. control group (GA) and study group (GB). Patients in (GA) will be treated by a designed physiotherapy program consisted of aerobic exercise on treadmill, stretching exercise, Proprioceptive neuromuscular facilitation (PNF) techniques, Graduated active exercises, gait training, Reciprocal and weight shifting exercises for 60 minutes/session. Patients in (GB) will be treated by computer-based cognitive training (30 minutes) in addition to the same physiotherapy program as GA (30 minutes).
| Arm | Type | Receives |
|---|---|---|
| Control group (GA) | Placebo comparator | Other: A Designed Physical Therapy ProgramPatients in control group (GA) will be treated by a designed physiotherapy program consisted of aerobic exercise on treadmill, stretching exercise, Proprioceptive neuromuscular facilitation (PNF) techniques, Graduated active exercises, gait training, Reciprocal and weight shifting exercises for 60 minutes/session, 3 days/week for 8 consecutive weeks |
| Study group (GB) | Experimental | Device: REHACOM Software, Other: A Designed Physical Therapy ProgramPatients in (GB) will be treated by computer-based cognitive training for 30 minutes followed by the same physiotherapy program as GA for another 30 minutes. so the whole duration of the treatment session for (GB) is 60 minutes ( half of the session the computerized cognitive training and the other half is for the designed physical therapy program). the whole treatment intervention will be 3 days /week for 8 consecutive weeks. |
Who may qualify
- Ages
- 58 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Egyptian Parkinson's Disease patients of both sex , all patients fulfilled the U.K Parkinson's Disease Brain Bank Criteria for diagnosis of idiopathic PD.
- The patients' age ranged from 58 to 68 years.
- The duration of illness ranged from two to five years.
- The severity of the disease ranged from mild to moderate disability according to UPDRS motor scores (part III) and Modified Hoehn and Yahr staging (stage 2.5\&3) .
- Cognitive function ranged from 65 to 81 according to Parkinson's Disease-Cognitive Rating Scale (PD-CRS) that indicates mild cognitive impairment.
Key exclusion criteria (11 listed)
- Patients with secondary parkinsonism (Drug-induced, post traumatic, or post infectious) or atypical parkinsonism.
- Patients with major language disturbance, severe physical, auditory or visual impairment affecting their ability to complete testing.
- Patients with magnetic devices or any other implanted device (e.g., metallic implants such as pacemakers, surgical aneurysm clips…etc).
- Patients with a history of seizure, head injury or brain surgery.
- Complicating or unstable cardiovascular disease (unstable angina, recent myocardial infarction within the last three months, congestive heart failure, significant heart valve dysfunction, or unstable hypertension) or pulmonary disorders.
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 |
|---|---|---|
| REHACOM SoftwareAlso: Computer-Based Cognitive TrainingIt is a computer-based cognitive rehabilitation test that includes 32 cognition training tasks for attention/concentration, reaction behavior, memory , logical reasoning \& executive functioning with graded difficulty . It is composed of regular PC , 1G RAM , DVD drive, 100 GB hard drive with windows XP SP3, 128 MB RAM direct 3D graphic card , Screen at least 19" , regular PC keyboard or Rehacom panel \& printer .The Rehacom software version is (patientenpult (1990-1997) EN/ISO-13485-certified). * For each Cognitive training domain there is one hundred levels of difficulty. * Each patient is evaluated from level one(1) ang gradually increase the difficulty till we reach the level that will be used in the treatment sessions as the patient's performance improve we can proceed to the next level. * The period of the session was chosen to be maximum (60 minutes) for each patient with five minutes rest in between each level. | Device | Study group (GB) |
| A Designed Physical Therapy ProgramA designed physiotherapy program consisted of aerobic exercise on treadmill, stretching exercise, Proprioceptive neuromuscular facilitation (PNF) techniques, Graduated active exercises, postural correction, gait training, balance training on different base of supports using static and dynamic balance training with reciprocal and weight shifting exercises. | Other | Control group (GA), Study group (GB) |
Primary outcome
Overall Stability Index
Time frame: Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up)
o Overall balance index: represents the patient's ability to control balance in all directions. High values indicate balance disturbance (increase rate of body swaying during the test).
Anterior / posterior (A/P) index
Time frame: Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up)
o Anterior / posterior (A/P) index represents the patient's ability to control balance in front to back direction.
Medial/ lateral (M/L) index
Time frame: Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up)
o Medial/ lateral (M/L) index: represents the patient's ability to maintain balance from side to side.
Velocity of Gait
Time frame: Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up)
Using 2D motion analysis in Kinovea program for spatiotemporal gait analysis o Velocity = Distance/Time * The total distance: represented by the actual length that the patient walked and this was presented by the blue line (three meters). * The total duration of walking (seconds): was calculated by using the ''stop watch'' tool in kinovea program. Velocity meter/seconds: was calculated by dividing the total distance that had been walked by the patient over the total duration.
Cadence of Gait
Time frame: Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up)
Using 2D motion analysis in Kinovea program for spatiotemporal gait analysis Cadence is the Number of steps/Minute * Number of steps: calculated by counting the steps the patient walked from the beginning to the end of the walkway (blue line). * Cadence was calculated by dividing the number of steps that the patient walked over the actual duration of walking.
Stride Length
Time frame: Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up)
Using 2D motion analysis in Kinovea program, stride length was the distance from the first initial contact of one foot (1st frame) to the next initial contact of the ipsilateral foot (2nd frame).
1 secondary outcome
Overall cognitive performance
Time frame: Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- 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. This study is not recruiting at the moment.
Engy B Saleh, PhD principal investigator
Faculty of Physical Therapy, Cairo University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REHACOM Software and A Designed Physical Therapy Program in people with Parkinson Disease, run by Engy Badreldin Saleh Moustafa, PhD at 1 site in Egypt.
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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 9 Apr 2025. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Engy B Saleh, PhD (00201099445112, engybm.saleh@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Stability Index (time frame: Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (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 9 Apr 2025.