MS (Multiple Sclerosis)NCT05991297
Effects of Deep Sensory Assisted Rehabilitation on Gait and Balance in Patients With Multiple Sclerosis
A study testing Deep sensory assisted rehabilitation and classical rehabilitation in people with MS (Multiple Sclerosis), run by Nermin Çalışır at 2 sites in Turkey (Türkiye).
Trial summary
The effect of physical therapy and rehabilitation on improving the gait and balance disorders of patients has been proven. FTR applications in MS patients have become routine in developed countries. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- MS (Multiple Sclerosis)
- What is being tested?
- Deep sensory assisted rehabilitation and classical rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 1 Jun 2024
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with multiple sclerosis
- 20-60 years old
- EDSS between 3.0-5.5 Those with EDSS 0-2.5 and spinal and/or cerebellar involvement
- Had the last MS attack at least 3 months ago
Who cannot join
- schizoaffective disorder
- lower extremity amputation
- shortness on one side creating asymmetry in the lower extremities
- diabetes mellitus
- cognitive impairment (at a level that may interfere with communication)
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, Yildirim
Romatem Physical Therapy and Rehabilitation Hospitals Bursa Hospital
Bursa, 16030
About this study
The effect of physical therapy and rehabilitation on improving the gait and balance disorders of patients has been proven. FTR applications in MS patients have become routine in developed countries. However, due to the high patient density in our country, FTR cannot be performed at the rate we want due to different reasons such as the inability to separate areas special for MS patients, the lack of special FTR applications for MS patients, and the inability to perform regular FTR follow-ups. Even if FTR is recommended and performed, our patients think that FTR is not very effective due to the above reasons and they do not continue.
A team of neurology, physical therapy specialists, and physiotherapists was formed, in-service training was completed and a special rehabilitation program for MS patients was created. First of all, we will apply routine classical FTR to our patients. Sensory and deep sensory disorders, which are more common and severe, especially in the lower extremities, also negatively affect gait and balance.
A rehabilitation program was created by adding exercises to improve sensation and deep sense, along with muscle strengthening. The results of the 1st and 21st sessions of the patients in the two groups who underwent classical rehabilitation and deep sensory-assisted rehabilitation will be compared. It was planned to evaluate the gait and balance parameters of the patients as numerical data with clinical scales and the C mill device we used in walking and balance exercises.
Read the detailed description
Muscle strengthening in all four extremities; strengthening of trunk and abdominal muscles; providing and maintaining joint range of motion; independent and safe standing, turning, and stepping; able to walk alone on flat ground and on different surfaces (such as sloping-handicapped-soil-stone-sand-grass-rough-stepped); increase in exercise capacity, duration, distance; An increase in the number of steps per minute and step length is expected.
It was thought that both classical rehabilitation and deep sensory-assisted rehabilitation would improve gait and balance parameters.
There has been previous research showing the effects of FTR. What we will do in addition and new with this research;
- The effects of classical rehabilitation and deep sensory-assisted rehabilitation will be compared
- A new PTR plan called "deep sensory assisted rehabilitation" was created: it was aimed to develop a sensory and deep sense in the adult age group by making use of sensory integration exercises, which are mostly applied in the childhood age group. Whether these exercises are effective on walking and balance will be evaluated. Patients will be dressed in a vest with an equally distributed weight of 4-6 kg according to their weight, and exercises will be done while walking and standing.
- the so-called "deep sensory pathway"; The patients will be given standing and walking exercises on sand and stone floors, soft floors made of sponge, hard plastic floors with different sizes of grooves and shapes, and hot-cold floors formed by placing hot packs and cold packs.
- Most of the previous studies have shown the effect of FTR using clinical scales. In developed countries, gait analysis was performed. In our research, we aimed to measure gait and balance parameters in C-mill walking and balance exercise devices, together with clinical scales, as numerical data and graphics. The patient's standing and walking on the treadmill, stride length, stride symmetry, walking speed, distance, duration, cadence, and percentage deviation from targets during tandem and slalom walking parameters will be recorded as objective numerical data and graphics. These measurements will be recorded in the 1st session and the 21st session.
Changes in patients will be seen with clinical scales and visual evaluations. However, in order to make the evaluation more objective for both the patient and the practitioner, these measurements made with the C mill will also be made.
- Conditions
- MS (Multiple Sclerosis)
- Being tested
- Deep sensory assisted rehabilitation, classical rehabilitation
- Keywords
- deep sensory assisted rehabilitation, MS gait and balance, deep sensory walkway
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep sensory assisted rehabilitationOther
A new PTR plan called "deep sensory assisted rehabilitation" was created: it was aimed to develop a sensory and deep sense in the adult age group by making use of sensory integration exercises, which are mostly applied in the childhood age group. Whether these exercises are effective on walking and balance will be evaluated. Patients will be dressed in a vest with an equally distributed weight of 4-6 kg according to their weight, and exercises will be done while walking and standing.
- the so-called "deep sensory pathway"; The patients will be given standing and walking exercises on sand and stone floors, soft floors made of sponge, hard plastic floors with different sizes of grooves and shapes, and hot-cold floors formed by placing hot packs and cold packs.
classical rehabilitationOther
Muscle strengthening in all four extremities; strengthening of trunk and abdominal muscles; providing and maintaining joint range of motion; independent and safe standing, turning, and stepping; able to walk alone on flat ground and on different surfaces (such as sloping-handicapped-soil-stone-sand-grass-rough-stepped)
| Study group | Role | What they receive |
|---|---|---|
| Classical physical therapy and rehabilitation program | Active comparator | Classical rehabilitation program (stretching, strenght, balance and coordination exercise) for fifty minutes. Receives: Other: classical rehabilitation |
| Deep sensory asisted therapy and rehabilitation program | Experimental | Deep sensory asisted rehabilitation program (stretching, strenght, balance and coordination and deep sensory exercises) for fifty minutes. Receives: Other: Deep sensory assisted rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multipl sclerosis quality of life-54(MSQOL-54)
: It is calculated with the combined summary scores of physical and mental health. As the total score increases, the quality of life is evaluated positively.
Measured: 1st day: when rehabilitation applications started
Multipl sclerosis quality of life-54(MSQOL-54)
: It is calculated with the combined summary scores of physical and mental health. As the total score increases, the quality of life is evaluated positively. The scale has not minimum and maximum value. The change between the participant's prior and values was evaluated.
Measured: after 7 weeks: when rehabilitation applications ended
MiniBest test
minimum and maximum score: 0-28: high score indicates good functional balance
Measured: 1st day: when rehabilitation applications started
MiniBest test
minimum and maximum score: 0-28: high score indicates good functional balance
Measured: after 7 weeks: when rehabilitation applications ended
10 meter walking time
The patient's walking time of the determined 10-meter distance is measured.
Measured: 1st day: when rehabilitation applications started
10 meter walking time
The patient's walking time of the determined 10-meter distance is measured.
Measured: after 7 weeks: when rehabilitation applications ended
Nottingham Extended Activities of Daily Living Scale
minimum and maximum score: 0-66: high score indicates no restriction in activities of daily living.
Measured: 1st day: when rehabilitation applications started
Nottingham Extended Activities of Daily Living Scale
minimum and maximum score: 0-66: high score indicates no restriction in activities of daily living.
Measured: after 7 weeks: when rehabilitation applications ended
Functional Ambulation Classification
minimum and maximum score :0-5: high score indicates that walking can be done independently.
Measured: 1st day: when rehabilitation applications started
Functional Ambulation Classification
minimum and maximum score :0-5: high score indicates that walking can be done independently.
Measured: after 7 weeks: when rehabilitation applications ended
Fatigue Severity Score
A score lower than 2.8 indicates no fatigue, a score higher than 6.1 indicates chronic fatigue
Measured: 1st day: when rehabilitation applications started
Fatigue Severity Score
A score lower than 2.8 indicates no fatigue, a score higher than 6.1 indicates chronic fatigue
Measured: after 7 weeks: when rehabilitation applications ended
DN4(Douleur Neuropathique 4 Questions)
Minimum and maximum score: 0-10: A score of 4 and above indicates neuropathic pain.
Measured: 1st day: when rehabilitation applications started
DN4(Douleur Neuropathique 4 Questions)
Minimum and maximum score: 0-10: A score of 4 and above indicates neuropathic pain.
Measured: after 7 weeks: when rehabilitation applications ended
MSWS-12( MS walking scale-12)
minimum and maximum scores: 12-54: low scores indicate that gait disturbance has little effect on disability.
Measured: 1st day: when rehabilitation applications started
MSWS-12( MS walking scale-12)
minimum and maximum scores: 12-54: low scores indicate that gait disturbance has little effect on disability.
Measured: after 7 weeks: when rehabilitation applications ended
FES-1: (Falls Efficay Scale-1)
minimum and maximum score: 16-64: higher score indicates increased anxiety about falling
Measured: 1st day: when rehabilitation applications started
FES-1: (Falls Efficay Scale-1)
minimum and maximum score: 16-64: higher score indicates increased anxiety about falling
Measured: after 7 weeks: when rehabilitation applications ended
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Jun 2023
- Primary completion1 Feb 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MS (Multiple Sclerosis)Studies 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
- classic rehabilitation group vs.deep sensory assisted rehabilitation group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nermin Çalışır
- Sponsor type
- University, hospital or other
- Collaborators
- Bursa Sevket Yilmaz Training and Research Hospital
- Responsible party
- Sponsor-investigator, Nermin Çalışır, Romatem Bursa Hospital
- Investigators
- NERMİN ÇALIŞIR, Study chair, ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITALNURTEN KÜÇÜKÇAKIR, Study director, ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITALMERAL SEFEROĞLU, Study director, Bursa Yuksek Ihtisas Training and Research HospitalALİ ÖZHAN SIVACI, Principal investigator, Bursa Yuksek Ihtisas Training and Research HospitalCELAL BATUHAN GÜNEYSU, Principal investigator, ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITALİSMAİL HACIOĞLU, Principal investigator, ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITALYUSUF ZİYA ŞAHİN, Principal investigator, ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITALMUHAMMED SOC HASANOĞLU, Principal investigator, ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991297
- Sponsor's protocol ID
- ROMATEM-NERMİN ÇALIŞIR 2023
- Status last verified
- Jan 2026
- First submitted
- 26 Jul 2023
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Deep Sensory Assisted Rehabilitation on Gait and Balance in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05991297
- Acronym / sponsor ID
- ROMATEM-NERMİN ÇALIŞIR 2023
- Conditions
- MS (Multiple Sclerosis)
- Keywords
- deep sensory assisted rehabilitation, MS gait and balance, deep sensory walkway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nermin ÇalışırUniversity, hospital or other
- Collaborators
- Bursa Sevket Yilmaz Training and Research Hospital
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 14 Aug 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.
The effect of physical therapy and rehabilitation on improving the gait and balance disorders of patients has been proven. FTR applications in MS patients have become routine in developed countries. However, due to the high patient density in our country, FTR cannot be performed at the rate we want due to different reasons such as the inability to separate areas special for MS patients, the lack of special FTR applications for MS patients, and the inability to perform regular FTR follow-ups. Even if FTR is recommended and performed, our patients think that FTR is not very effective due to the above reasons and they do not continue.
A team of neurology, physical therapy specialists, and physiotherapists was formed, in-service training was completed and a special rehabilitation program for MS patients was created. First of all, we will apply routine classical FTR to our patients. Sensory and deep sensory disorders, which are more common and severe, especially in the lower extremities, also negatively affect gait and balance.
A rehabilitation program was created by adding exercises to improve sensation and deep sense, along with muscle strengthening. The results of the 1st and 21st sessions of the patients in the two groups who underwent classical rehabilitation and deep sensory-assisted rehabilitation will be compared. It was planned to evaluate the gait and balance parameters of the patients as numerical data with clinical scales and the C mill device we used in walking and balance exercises.
Detailed description
Muscle strengthening in all four extremities; strengthening of trunk and abdominal muscles; providing and maintaining joint range of motion; independent and safe standing, turning, and stepping; able to walk alone on flat ground and on different surfaces (such as sloping-handicapped-soil-stone-sand-grass-rough-stepped); increase in exercise capacity, duration, distance; An increase in the number of steps per minute and step length is expected.
It was thought that both classical rehabilitation and deep sensory-assisted rehabilitation would improve gait and balance parameters.
There has been previous research showing the effects of FTR. What we will do in addition and new with this research;
- The effects of classical rehabilitation and deep sensory-assisted rehabilitation will be compared
- A new PTR plan called "deep sensory assisted rehabilitation" was created: it was aimed to develop a sensory and deep sense in the adult age group by making use of sensory integration exercises, which are mostly applied in the childhood age group. Whether these exercises are effective on walking and balance will be evaluated. Patients will be dressed in a vest with an equally distributed weight of 4-6 kg according to their weight, and exercises will be done while walking and standing.
- the so-called "deep sensory pathway"; The patients will be given standing and walking exercises on sand and stone floors, soft floors made of sponge, hard plastic floors with different sizes of grooves and shapes, and hot-cold floors formed by placing hot packs and cold packs.
- Most of the previous studies have shown the effect of FTR using clinical scales. In developed countries, gait analysis was performed. In our research, we aimed to measure gait and balance parameters in C-mill walking and balance exercise devices, together with clinical scales, as numerical data and graphics. The patient's standing and walking on the treadmill, stride length, stride symmetry, walking speed, distance, duration, cadence, and percentage deviation from targets during tandem and slalom walking parameters will be recorded as objective numerical data and graphics. These measurements will be recorded in the 1st session and the 21st session.
Changes in patients will be seen with clinical scales and visual evaluations. However, in order to make the evaluation more objective for both the patient and the practitioner, these measurements made with the C mill will also be made.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- classic rehabilitation group vs.deep sensory assisted rehabilitation group
| Arm | Type | Receives |
|---|---|---|
| Classical physical therapy and rehabilitation program | Active comparator | Other: classical rehabilitationClassical rehabilitation program (stretching, strenght, balance and coordination exercise) for fifty minutes. |
| Deep sensory asisted therapy and rehabilitation program | Experimental | Other: Deep sensory assisted rehabilitationDeep sensory asisted rehabilitation program (stretching, strenght, balance and coordination and deep sensory exercises) for fifty minutes. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosed with multiple sclerosis
- 20-60 years old
- EDSS between 3.0-5.5 Those with EDSS 0-2.5 and spinal and/or cerebellar involvement
- Had the last MS attack at least 3 months ago
Key exclusion criteria (5 listed)
- schizoaffective disorder
- lower extremity amputation
- shortness on one side creating asymmetry in the lower extremities
- diabetes mellitus
- cognitive impairment (at a level that may interfere with communication)
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 |
|---|---|---|
| Deep sensory assisted rehabilitationA new PTR plan called "deep sensory assisted rehabilitation" was created: it was aimed to develop a sensory and deep sense in the adult age group by making use of sensory integration exercises, which are mostly applied in the childhood age group. Whether these exercises are effective on walking and balance will be evaluated. Patients will be dressed in a vest with an equally distributed weight of 4-6 kg according to their weight, and exercises will be done while walking and standing. - the so-called "deep sensory pathway"; The patients will be given standing and walking exercises on sand and stone floors, soft floors made of sponge, hard plastic floors with different sizes of grooves and shapes, and hot-cold floors formed by placing hot packs and cold packs. | Other | Deep sensory asisted therapy and rehabilitation program |
| classical rehabilitationMuscle strengthening in all four extremities; strengthening of trunk and abdominal muscles; providing and maintaining joint range of motion; independent and safe standing, turning, and stepping; able to walk alone on flat ground and on different surfaces (such as sloping-handicapped-soil-stone-sand-grass-rough-stepped) | Other | Classical physical therapy and rehabilitation program |
Primary outcome
Multipl sclerosis quality of life-54(MSQOL-54)
Time frame: 1st day: when rehabilitation applications started
: It is calculated with the combined summary scores of physical and mental health. As the total score increases, the quality of life is evaluated positively.
Multipl sclerosis quality of life-54(MSQOL-54)
Time frame: after 7 weeks: when rehabilitation applications ended
: It is calculated with the combined summary scores of physical and mental health. As the total score increases, the quality of life is evaluated positively. The scale has not minimum and maximum value. The change between the participant's prior and values was evaluated.
MiniBest test
Time frame: 1st day: when rehabilitation applications started
minimum and maximum score: 0-28: high score indicates good functional balance
MiniBest test
Time frame: after 7 weeks: when rehabilitation applications ended
minimum and maximum score: 0-28: high score indicates good functional balance
10 meter walking time
Time frame: 1st day: when rehabilitation applications started
The patient's walking time of the determined 10-meter distance is measured.
10 meter walking time
Time frame: after 7 weeks: when rehabilitation applications ended
The patient's walking time of the determined 10-meter distance is measured.
Nottingham Extended Activities of Daily Living Scale
Time frame: 1st day: when rehabilitation applications started
minimum and maximum score: 0-66: high score indicates no restriction in activities of daily living.
Nottingham Extended Activities of Daily Living Scale
Time frame: after 7 weeks: when rehabilitation applications ended
minimum and maximum score: 0-66: high score indicates no restriction in activities of daily living.
Functional Ambulation Classification
Time frame: 1st day: when rehabilitation applications started
minimum and maximum score :0-5: high score indicates that walking can be done independently.
Functional Ambulation Classification
Time frame: after 7 weeks: when rehabilitation applications ended
minimum and maximum score :0-5: high score indicates that walking can be done independently.
Fatigue Severity Score
Time frame: 1st day: when rehabilitation applications started
A score lower than 2.8 indicates no fatigue, a score higher than 6.1 indicates chronic fatigue
Fatigue Severity Score
Time frame: after 7 weeks: when rehabilitation applications ended
A score lower than 2.8 indicates no fatigue, a score higher than 6.1 indicates chronic fatigue
DN4(Douleur Neuropathique 4 Questions)
Time frame: 1st day: when rehabilitation applications started
Minimum and maximum score: 0-10: A score of 4 and above indicates neuropathic pain.
DN4(Douleur Neuropathique 4 Questions)
Time frame: after 7 weeks: when rehabilitation applications ended
Minimum and maximum score: 0-10: A score of 4 and above indicates neuropathic pain.
MSWS-12( MS walking scale-12)
Time frame: 1st day: when rehabilitation applications started
minimum and maximum scores: 12-54: low scores indicate that gait disturbance has little effect on disability.
MSWS-12( MS walking scale-12)
Time frame: after 7 weeks: when rehabilitation applications ended
minimum and maximum scores: 12-54: low scores indicate that gait disturbance has little effect on disability.
FES-1: (Falls Efficay Scale-1)
Time frame: 1st day: when rehabilitation applications started
minimum and maximum score: 16-64: higher score indicates increased anxiety about falling
FES-1: (Falls Efficay Scale-1)
Time frame: after 7 weeks: when rehabilitation applications ended
minimum and maximum score: 16-64: higher score indicates increased anxiety about falling
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
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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.
NERMİN ÇALIŞIR study chair
ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
NURTEN KÜÇÜKÇAKIR study director
ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
MERAL SEFEROĞLU study director
Bursa Yuksek Ihtisas Training and Research Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep sensory assisted rehabilitation and classical rehabilitation in people with MS (Multiple Sclerosis), run by Nermin Çalışır at 2 sites in Turkey (Türkiye).
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 5 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: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multipl sclerosis quality of life-54(MSQOL-54) (time frame: 1st day: when rehabilitation applications started). The study lists 18 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 13 Jan 2026.