Cerebral Palsy (CP)NCT06945835
High Intensity Exercise and Improving Physical Activity Among People With Neurologic Dysfunction
A study testing Participate in high intensity exercise of at least 20 minutes in 60 minutes session of RPE greater than 6. in people with Cerebral Palsy (CP) and Stroke, run by University of Hartford at 1 site in United States.
Trial summary
The Hawks in Motion (HIM) High Intensity Exercise program is designed to implement the American Physical Therapy Clinical Practice Guidelines and American College of Sports Medicine recommendations for exercise for people with neurologic disability. Read more about this study
- Who is it for?
- Ages 8 to 99 years
- Conditions the study is for
- Cerebral Palsy (CP), Stroke, Spinal Cord Injury
- What is being tested?
- Participate in high intensity exercise of at least 20 minutes in 60 minutes session of RPE greater than 6.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2025to 27 May 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 8 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- physical disability that limits mobility and activities of daily living, and a neurodevelopmental disability OR neurological disability,
- age 8-99 years of age,
- understands verbal instructions,
- able to obtain medical clearance,
- able to obtain transportation to campus,
- have a parent/guardian/caregiver on site if not own legal authorized representative,
- English speaking.
Who cannot join
- no presence of a physical disability that impacts activities of daily living, no neurodevelopmental or neurological disability as an underlying cause,
- no person-centered goals (locomotion, fitness, transfers, and mobility),
- unstable cardiac condition,
- uncontrolled seizures,
- unstable oxygen saturation levels,
- no clearance from primary care physician for exercise,
- unable to read and understand English,
- pursuing active litigation for their physical condition.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Hartford
West Hartford, Connecticut, 06117
About this study
Official title: Can a High Intensity Exercise Program for People With Neurologic Disabilities Run by Doctoral of Physical Therapy Students Improve Mobility in Everyday Life
The Hawks in Motion (HIM) High Intensity Exercise program is designed to implement the American Physical Therapy Clinical Practice Guidelines and American College of Sports Medicine recommendations for exercise for people with neurologic disability. Doctor of Physical Therapy (DPT) students administer the HIM High Intensity Exercise Program. A prior study evaluated the feasibility, safety, and efficacy of the HIM High Intensity Exercise Program and found it feasible, safe, and effective for 30 people with neurologic disabilities between the ages of 8-99 years. The investigators would like to evaluate whether participation in the HIM High Intensity Exercise Program affects mobility in everyday life. Physical activity will be measured one week before program implementation and one week after to assess if the participants' mobility in everyday improved.
Read the detailed description
The neurological conditions of spinal cord injury (SCI), stroke (CVA), traumatic brain injury (TBI), cerebral palsy (CP), Charcot-Marie-Tooth (CMT), and Parkinson's disease (PD) create a variety of physical impairments that make movement difficult. For example, people with SCI can have complete or partial paralysis of the arms, legs, and or trunk depending on the location and severity of injury. People with CMT have paralysis in specific muscles of the hands, feet, and trunk. Similarly, people with TBI, CVA, and CP can experience increased muscle tone, decreased voluntary movement, and difficulty moving at correct speeds. This makes walking, moving surface to surface, and doing other physical activities difficult, frustrating, and tiring. People tend not to move, and end up with chronic pain, heart disease, diabetes, and poor health. Physical inactivity is one of the most concerning issues among individuals with chronic neurological conditions, often resulting in limited community participation and reduced quality of life. Many individuals with these conditions struggle to achieve sufficient physical activity levels necessary for functional independence and movement in the community, essential for maintaining social connections and overall well-being. Despite the known benefits of moderate-to-vigorous physical activity, challenges persist in improving mobility in community settings. It has been hypothesized that by increasing function and endurance, which the HIM High Intensity Program can do, mobility in everyday life may improve. The purpose of the project is to see if physical activity among individuals with chronic neurological disabilities can be increased by participation in a community-based exercise program. The investigators would like to answer the following research question: Does participation in an 8-week, twice-a-week high-intensity exercise program for people with neurologic disability run by Doctor of Physical Therapy students increase physical activity in the everyday life?
- Conditions
- Cerebral Palsy (CP), Stroke, Spinal Cord Injury, Traumatic Brain Injury, Charcot Marie Tooth Disease (CMT), Spina Bifida
- Being tested
- Participate in high intensity exercise of at least 20 minutes in 60 minutes session of RPE greater than 6.
- Keywords
- high intensity exercise, physical activity, physical disability
- Medical subject headings
- Cerebral Palsy, Stroke, Spinal Cord Injuries, Brain Injuries, Traumatic, Charcot-Marie-Tooth Disease, Spinal Dysraphism, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participate in high intensity exercise of at least 20 minutes in 60 minutes session of RPE greater than 6.Behavioural
Partticipants will be performing supported and unsupported walking, free weights, rowing, cycling, resistance bands, adaptive bikes and body weight exercises.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Participants will receive two times a week for 8 weeks one hour of individualized exercise program that is based on clinical practice guidelines for high intensity exercise. Receives: Behavioral: Participate in high intensity exercise of at least 20 minutes in 60 minutes session of RPE greater than 6. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Gait Assessment-(FGA)
The Functional Gait Assessment assesses postural stability during walking and assesses an individual's ability to perform multiple motor tasks while walking, with rating of performance on a scale of 0-30, with higher scores indicating better performance. The tool is reliable and valid and has an established minimally clinical important difference (MCID) for the included diagnoses: stroke, vestibular disorders, older adults and geriatric care, Parkinson's Disease, and other non-specific patient populations. For those who cannot complete this test, they will do the Berg Balance Test.
Measured: Baseline and through study completion, an average of 8 weeks
Canadian Occupational Performance Measure (COPM)
The Canadian Occupational Performance Measure is a semi-structured Interview by which participants rate satisfaction and performance on patient-identified goals a scale of 1 to 10, with 1 being the lowest and 10 being the highest.
Measured: Baseline and through study completion, an average of 8 weeks
Berg Balance Scale- (BBS)
The Berg Balance Scale evaluates one's ability to maintain a position and perform a specific task. The scale for scoring is based on a 5-point scale 0 being unable to complete 4 being able to complete, scores ranging 0-70. Higher scores indicate better performance. There are 14 items on the test including; sitting to standing, standing unsupported, sitting with back unsupported, standing to sitting, transfers, standing unsupported with eyes closed, standing unsupported feet together, reaching forward with outstretched arm while standing, pick up object from floor from standing, turning to look behind over both shoulders, 360 turn, toe touch unsupported, tandem unsupported, and single leg stance. The tool is reliable and valid and has an established MCID for the included diagnoses: stroke, SCI, and Parkinson's patients.
Measured: Baseline and through study completion, an average of 8 weeks
Activities-Specific Balance Confidence Scale (ABS)
The Activities Balance Scale is a self-report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness, with 16 items. Each item is rated from 0% to 100%, with 0 indicating no confidence and 100% indicating complete confidence. All items are averaged for a total balance confidence score of 0-100%. Higher scores overall indicate greater balance confidence.
Measured: Baseline and through study completion, an average of 8 weeks
10 Meter Walk Test- (10MWT)
The 10-meter walk test is a clinical assessment used to measure short-duration walking speed in meter per seconds (m/s). It involves measuring the time it takes a participant to walk 10 meters, often with a focus on the middle 6 meters to minimize the effects of acceleration and deceleration. Average gait speed is 1.2 m/s, and can be as low as 0.3 in populations with an assistive device. A faster gait speed, or a score of less time indicates better performance. The test is frequently used to assess gait speed in various populations, including those with conditions like stroke, Parkinson's disease, and dementia.
Measured: Baseline and through study completion, an average of 8 weeks
5 Times Sit to Stand: (5XSTS)
The five time sit to stand aids in quantifying functional lower extremity strength and assessing the participant's movement strategies in performing transitional movements. The participant is instructed to sit up and down five times without using their arms as fast as they can after the clinician says "Go", and the timer stops after the patient sits down for the fifth repetition. Time varies by age group, but scores above 12 seconds may indicate fall risk. A faster speed indicates better performance. This outcome measure can be used within a variety of populations, including vestibular disorders, stroke, Parkinson's Disease, Older Adults, Multiple Sclerosis, Cerebral Palsy, and other non-specific patient populations as well. It has excellent validity and reliability, and the MCID has been established.
Measured: Baseline and through study completion, an average of 8 weeks
Timed 30 second repetition arm curl.
For Individuals who are wheelchair users, and are therefore unable to stand, or who cannot safely perform standing tests a timed arm curl test will be performed. The purpose of this test is to assess upper extremity strength and endurance. The test is conducted using the dominant arm. The participant is seated on a chair with feet flat on the floor, holding a 5-pound weight in a suitcase grip (palm is facing the body) in a vertically down position by the chair (start position). The participant performs an arm curl throughout a full range of motion, gradually turning the palm up and the elbow fully bent. The arm is lowered again to the starting position with the elbow fully straightened. The participant performs as many as possible in 30 seconds. Range of number of arm cults can be from 0-30. The average number varies by age and gender, but a high number repetitions performed in 30 seconds indicates better muscle performance.
Measured: Baseline and through study completion, an average of 8 weeks
Timed 30 second Wheelchair Push Ups.
Participants who use a wheelchair as primary means of locomotion will do timed 30 second wheelchair pushups. The participant demonstrates how many wheelchair pushups can be completed in 30 seconds. A push-up is when the bottom is unweighted from the seat. Range of pushup can be from 0-30. A high number repetitions performed in 30 seconds indicates better muscle performance.
Measured: Baseline and through study completion, an average of 8 weeks
Six minute walk test (6MWT)/6 minute push test)
The 6MWT/push test is a sub-maximal exercise test used to assess walking or locomotion endurance and aerobic capacity. Participants will walk/push a set circuit for a total of six minutes. Distance is measured during the 6MWT or push test. Distances walked can range from 0 to 2500 meters. Longer distances indicate increased endurance and aerobic capacity.
Measured: Baseline and through study completion, an average of 8 weeks
Secondary outcomes (1)
Physical Activity Monitoring
The Actigraph GTX will be used to measure physical activity across 7 days before and after the activity. It will be worn on the waist for people who ambulate and on the wrist for those who use a wheelchair. We will classify the movement patterns into sedentary and moderate to vigorous activity using the software with the accelerometers, and this will be compared pre- and post-intervention. The investigators evaluate average steps, percentage of time in sedentary, light, moderate, vigorous, and very vigorous activity per week. Range of average steps is 0-unlimited and average time spent in sedentary light, moderate, vigorous, and very vigorous activity per week is 0-100% . A higher number of steps with less time in sedentary activity time indicate greater physical activity.
Measured: Baseline and through study completion, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start24 Feb 2025
- Primary completion27 May 2025
- Study completion27 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)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
- Not applicable
- Intervention model
- Single group
- Model description
- Pre test post test design.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hartford
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Gannotti, University of Hartford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945835
- Sponsor's protocol ID
- 24-10-371
- Status last verified
- Oct 2025
- First submitted
- 18 Feb 2025
- Last updated
- 3 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: none at this time
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a High Intensity Exercise Program for People With Neurologic Disabilities Run by Doctoral of Physical Therapy Students Improve Mobility in Everyday Life
- ClinicalTrials.gov ID
- NCT06945835
- Acronym / sponsor ID
- 24-10-371
- Conditions
- Cerebral Palsy (CP), Stroke, Spinal Cord Injury, Traumatic Brain Injury, Charcot Marie Tooth Disease (CMT), Spina Bifida
- Keywords
- high intensity exercise, physical activity, physical disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of HartfordUniversity, hospital or other
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 27 May 2025 (actual)
- Study completion
- 27 May 2025 (actual)
- First posted
- 25 Apr 2025 (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 Hawks in Motion (HIM) High Intensity Exercise program is designed to implement the American Physical Therapy Clinical Practice Guidelines and American College of Sports Medicine recommendations for exercise for people with neurologic disability. Doctor of Physical Therapy (DPT) students administer the HIM High Intensity Exercise Program. A prior study evaluated the feasibility, safety, and efficacy of the HIM High Intensity Exercise Program and found it feasible, safe, and effective for 30 people with neurologic disabilities between the ages of 8-99 years. The investigators would like to evaluate whether participation in the HIM High Intensity Exercise Program affects mobility in everyday life. Physical activity will be measured one week before program implementation and one week after to assess if the participants' mobility in everyday improved.
Detailed description
The neurological conditions of spinal cord injury (SCI), stroke (CVA), traumatic brain injury (TBI), cerebral palsy (CP), Charcot-Marie-Tooth (CMT), and Parkinson's disease (PD) create a variety of physical impairments that make movement difficult. For example, people with SCI can have complete or partial paralysis of the arms, legs, and or trunk depending on the location and severity of injury. People with CMT have paralysis in specific muscles of the hands, feet, and trunk. Similarly, people with TBI, CVA, and CP can experience increased muscle tone, decreased voluntary movement, and difficulty moving at correct speeds. This makes walking, moving surface to surface, and doing other physical activities difficult, frustrating, and tiring. People tend not to move, and end up with chronic pain, heart disease, diabetes, and poor health. Physical inactivity is one of the most concerning issues among individuals with chronic neurological conditions, often resulting in limited community participation and reduced quality of life. Many individuals with these conditions struggle to achieve sufficient physical activity levels necessary for functional independence and movement in the community, essential for maintaining social connections and overall well-being. Despite the known benefits of moderate-to-vigorous physical activity, challenges persist in improving mobility in community settings. It has been hypothesized that by increasing function and endurance, which the HIM High Intensity Program can do, mobility in everyday life may improve. The purpose of the project is to see if physical activity among individuals with chronic neurological disabilities can be increased by participation in a community-based exercise program. The investigators would like to answer the following research question: Does participation in an 8-week, twice-a-week high-intensity exercise program for people with neurologic disability run by Doctor of Physical Therapy students increase physical activity in the everyday life?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre test post test design.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Participate in high intensity exercise of at least 20 minutes in 60 minutes session of RPE greater than 6.Participants will receive two times a week for 8 weeks one hour of individualized exercise program that is based on clinical practice guidelines for high intensity exercise. |
Who may qualify
- Ages
- 8 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- physical disability that limits mobility and activities of daily living, and a neurodevelopmental disability OR neurological disability,
- age 8-99 years of age,
- understands verbal instructions,
- able to obtain medical clearance,
- able to obtain transportation to campus,
Key exclusion criteria (8 listed)
- no presence of a physical disability that impacts activities of daily living, no neurodevelopmental or neurological disability as an underlying cause,
- no person-centered goals (locomotion, fitness, transfers, and mobility),
- unstable cardiac condition,
- uncontrolled seizures,
- unstable oxygen saturation levels,
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 |
|---|---|---|
| Participate in high intensity exercise of at least 20 minutes in 60 minutes session of RPE greater than 6.Partticipants will be performing supported and unsupported walking, free weights, rowing, cycling, resistance bands, adaptive bikes and body weight exercises. | Behavioural | Intervention Arm |
Primary outcome
Functional Gait Assessment-(FGA)
Time frame: Baseline and through study completion, an average of 8 weeks
The Functional Gait Assessment assesses postural stability during walking and assesses an individual's ability to perform multiple motor tasks while walking, with rating of performance on a scale of 0-30, with higher scores indicating better performance. The tool is reliable and valid and has an established minimally clinical important difference (MCID) for the included diagnoses: stroke, vestibular disorders, older adults and geriatric care, Parkinson's Disease, and other non-specific patient populations. For those who cannot complete this test, they will do the Berg Balance Test.
Canadian Occupational Performance Measure (COPM)
Time frame: Baseline and through study completion, an average of 8 weeks
The Canadian Occupational Performance Measure is a semi-structured Interview by which participants rate satisfaction and performance on patient-identified goals a scale of 1 to 10, with 1 being the lowest and 10 being the highest.
Berg Balance Scale- (BBS)
Time frame: Baseline and through study completion, an average of 8 weeks
The Berg Balance Scale evaluates one's ability to maintain a position and perform a specific task. The scale for scoring is based on a 5-point scale 0 being unable to complete 4 being able to complete, scores ranging 0-70. Higher scores indicate better performance. There are 14 items on the test including; sitting to standing, standing unsupported, sitting with back unsupported, standing to sitting, transfers, standing unsupported with eyes closed, standing unsupported feet together, reaching forward with outstretched arm while standing, pick up object from floor from standing, turning to look behind over both shoulders, 360 turn, toe touch unsupported, tandem unsupported, and single leg stance. The tool is reliable and valid and has an established MCID for the included diagnoses: stroke, SCI, and Parkinson's patients.
Activities-Specific Balance Confidence Scale (ABS)
Time frame: Baseline and through study completion, an average of 8 weeks
The Activities Balance Scale is a self-report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness, with 16 items. Each item is rated from 0% to 100%, with 0 indicating no confidence and 100% indicating complete confidence. All items are averaged for a total balance confidence score of 0-100%. Higher scores overall indicate greater balance confidence.
10 Meter Walk Test- (10MWT)
Time frame: Baseline and through study completion, an average of 8 weeks
The 10-meter walk test is a clinical assessment used to measure short-duration walking speed in meter per seconds (m/s). It involves measuring the time it takes a participant to walk 10 meters, often with a focus on the middle 6 meters to minimize the effects of acceleration and deceleration. Average gait speed is 1.2 m/s, and can be as low as 0.3 in populations with an assistive device. A faster gait speed, or a score of less time indicates better performance. The test is frequently used to assess gait speed in various populations, including those with conditions like stroke, Parkinson's disease, and dementia.
5 Times Sit to Stand: (5XSTS)
Time frame: Baseline and through study completion, an average of 8 weeks
The five time sit to stand aids in quantifying functional lower extremity strength and assessing the participant's movement strategies in performing transitional movements. The participant is instructed to sit up and down five times without using their arms as fast as they can after the clinician says "Go", and the timer stops after the patient sits down for the fifth repetition. Time varies by age group, but scores above 12 seconds may indicate fall risk. A faster speed indicates better performance. This outcome measure can be used within a variety of populations, including vestibular disorders, stroke, Parkinson's Disease, Older Adults, Multiple Sclerosis, Cerebral Palsy, and other non-specific patient populations as well. It has excellent validity and reliability, and the MCID has been established.
Timed 30 second repetition arm curl.
Time frame: Baseline and through study completion, an average of 8 weeks
For Individuals who are wheelchair users, and are therefore unable to stand, or who cannot safely perform standing tests a timed arm curl test will be performed. The purpose of this test is to assess upper extremity strength and endurance. The test is conducted using the dominant arm. The participant is seated on a chair with feet flat on the floor, holding a 5-pound weight in a suitcase grip (palm is facing the body) in a vertically down position by the chair (start position). The participant performs an arm curl throughout a full range of motion, gradually turning the palm up and the elbow fully bent. The arm is lowered again to the starting position with the elbow fully straightened. The participant performs as many as possible in 30 seconds. Range of number of arm cults can be from 0-30. The average number varies by age and gender, but a high number repetitions performed in 30 seconds indicates better muscle performance.
Timed 30 second Wheelchair Push Ups.
Time frame: Baseline and through study completion, an average of 8 weeks
Participants who use a wheelchair as primary means of locomotion will do timed 30 second wheelchair pushups. The participant demonstrates how many wheelchair pushups can be completed in 30 seconds. A push-up is when the bottom is unweighted from the seat. Range of pushup can be from 0-30. A high number repetitions performed in 30 seconds indicates better muscle performance.
Six minute walk test (6MWT)/6 minute push test)
Time frame: Baseline and through study completion, an average of 8 weeks
The 6MWT/push test is a sub-maximal exercise test used to assess walking or locomotion endurance and aerobic capacity. Participants will walk/push a set circuit for a total of six minutes. Distance is measured during the 6MWT or push test. Distances walked can range from 0 to 2500 meters. Longer distances indicate increased endurance and aerobic capacity.
1 secondary outcome
Physical Activity Monitoring
Time frame: Baseline and through study completion, an average of 8 weeks
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 3 Nov 2025.
- Individual participant dataSharing planned: No. none at this time
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participate in high intensity exercise of at least 20 minutes in 60 minutes session of RPE greater than 6. in people with Cerebral Palsy (CP) and Stroke, run by University of Hartford at 1 site in United States.
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 8 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 3 Nov 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 United States. 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?
Functional Gait Assessment-(FGA) (time frame: Baseline and through study completion, an average of 8 weeks). The study lists 9 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 3 Nov 2025.