Hemiplegia and/or Hemiparesis Following StrokeEOICNCT04498429
Effect of Integrated Cueing on Functional Transfers in Chronic Stroke Survivors
A study testing Integrated Cueing Protocol and Verbal Cueing Protocol in people with Hemiplegia and/or Hemiparesis Following Stroke, run by Loma Linda University at 2 sites in United States.
Trial summary
Physical therapists frequently use manual cueing as a tool to improve movement quality in persons recovering from stroke but evidence to support its effectiveness is lacking. The purpose of this graduate student research study is to determine the immediate and carryover effects of an integrated verbal and manual… Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Hemiplegia and/or Hemiparesis Following Stroke
- What is being tested?
- Integrated Cueing Protocol and Verbal Cueing Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Nov 2020to 24 Aug 2022
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Right CVA with left hemiplegia > 6 Months
- Able to ambulate with no more than help than supervision
- Must be able to stand without an assistive device or ankle foot orthosis
- Must be able to follow two-step verbal commands
Who cannot join
- History of injury from a recent fall within the last 3 months
- Currently participating in rehabilitation during the time frame of their participation in this study
- Additional musculoskeletal or neurological conditions that may impair ability to perform sit to stand safely
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Loma Linda University Health
Loma Linda, California, 92350
Loma Linda University
Loma Linda, California, 92350
About this study
Official title: Effect of Integrated Manual and Verbal Cueing on Functional Transfers in Chronic Stroke Survivors: A Randomized Controlled Study
Physical therapists frequently use manual cueing as a tool to improve movement quality in persons recovering from stroke but evidence to support its effectiveness is lacking.
The purpose of this graduate student research study is to determine the immediate and carryover effects of an integrated verbal and manual facilitation approach used by physical therapists during sit to stand training on the midline alignment, muscle activation and quality of movement in chronic stroke survivors with hemiplegia.
Read the detailed description
Over the last few decades, the profession of physical therapy has heavily relied on manual facilitation to improve motor control and functional movement in persons recovering from stroke or other neurological impairments. In the 1950's, Berta Bobath created Neuro-Developmental Treatment (NDT), a systematic problem-solving approach that is one of the most widely used methodologies in neurorehabilitation. NDT relies heavily on verbal and tactile facilitation as an integrated approach to improve motor control in persons with hemiplegia. However, current systematic reviews have stated that adequate evidence for the effectiveness of neuro facilitation is lacking. In the current climate of evidence-based practice, neurologic physical therapists no longer blindly accept the use of traditional interventions and instead rely on peer-reviewed research studies to support their clinical decision-making.
However, the question remains for many physical therapists: are skilled manual cues really an essential ingredient in the post-stroke recipe? Most practicing neurologic physical therapists would claim that their hands are their most valuable tools and that the way in which they use their hands has a direct effect on movement patterns and functional outcomes with their patients. Ploughman and colleagues reported that manual tactile cues during gait had "robust but short-lived impacts on cadence and time in double support" during gait but their findings are merely a step in the right direction. An integrative approach of both manual and verbal cues have anecdotally shown to be effective to treat impairments from stroke but there continues to be a dearth of evidence to accurately support the pervasive use of manual facilitation by physical therapists. While support for manual tactile cueing is merely beginning to move in the right direction, strong evidence exists that task specific training can improve functional outcomes by focusing training on desired movements and activities. But what part does manual cueing truly play in task specific training? Sit to stand is an essential activity of daily living that is often impaired in stroke survivors and is commonly trained by physical therapists from both task specific training and NDT schools of thought. Physical therapists need further clarification as to which methods are most effective for facilitating maximum learning and recovery during this functional task in order to craft an ideal recipe.
Training correct movement patterns in order to improve functional independence is important at every stage of recovery after stroke. Kerr et al. suggested that successful sit to stand movements require proper training of the critical timing of events as well as improving synergistic activation of the appropriate lower limb musculature. Ultimately, asymmetry can lead to a conditioned suppression of available movement termed "learned non-use". Continual reinforcement of poor movement strategies thus leads to passive suppression of maximally efficient normal movements unless the stroke survivor is actively retrained to unlock masked abilities over time. Teasell and colleagues confirmed the importance of skilled rehabilitation throughout all phases of recovery including the chronic stroke phase, though this important population regularly experiences fewer opportunities to participate in therapy as time progresses. Measurable gains may be slower at this stage but the ability to perform essential mobility tasks remains just as important to the individual.
Thus, the purpose of this graduate student research study is to determine the immediate and carryover effects of an integrated verbal and manual facilitation approach during sit to stand training on the midline alignment, muscle activation and quality of movement in chronic stroke survivors with hemiplegia. By determining the essential ingredients that lead to an ideal recipe for success, physical therapists may have more evidence-based tools available to maximize the independence, quality of life and confidence of their patients.
Procedures: Session 1: All participants will complete the initial paperwork and then be randomized into Verbal Cueing Group or Verbal + Manual Cueing Group using envelopes that are predetermined from a random number table. Height will be assessed using a stadiometer and weight using a scale. Subjects will then have trajectory markers and surface electromyographic (EMG) sensors placed according to the chart. This includes 24 individual marker trajectories, two thigh clusters and two shank clusters of four trajectories each for a total of 40 markers and 6 surface EMG sensors that will be placed on major muscle groups of the lower extremities. Once the setup has been completed and verified, the subject will perform two static standing trials, followed by two initial sit to stand (STS) trials to determine their baseline variables. This format will be followed by both the Verbal Cueing and the Verbal + Manual Cueing throughout the treatment session. The first 5 repetitions of both groups will include part to whole task practice of partial sit to stand using scripted verbal cueing to facilitate understanding of the task. The goal of both groups is to improve midline orientation and alignment during the task of moving from sitting to standing.
After the first 5 repetitions, the subject will perform two sit to stand trials on their own following the clinician's scripted verbal commands. Next, five Manual + Verbal Cueing or Verbal Cueing trials will commence followed by another two PostCue trials. This repeated sequence of 5 cued trials followed by 2 assessment trials will continue for a total of 40 sit to stand trials. After a 5-minute rest period the subject will then be asked to perform two additional STS to determine retention of learning over that interval. Next, two isometrically resisted sit to stand trials will be performed for EMG normalization. Once the EMG normalization is completed, the subject will then be told they are done and may get up to leave. When they get up to leave, their sit to stand activity will also be discretely recorded for comparison to their last knowingly observed trial. This is based on the Actual Amount of Use Test (AAOUT) in which subjects are observed under normal circumstances to assess whether the learning was integrated into functional use when the subject doesn't think they are being observed.
At the end of session #1, the investigator will ask the subject what strategy most helped them achieve midline. Based on their feedback, the investigator will create and issue a home exercise program (HEP) handout that incorporates that subjective report. Examples include statements such as, "Feeling the pressure through my left leg" or "Leaning to my left". This cue will be placed on a brightly colored card that will be placed near where the subject practices sitting to standing most often in their home environment. The card will also contain an easy to mark log to encourage practice of the STS task over the next 3-5 days. The subject will be instructed to perform the exercises at the times specified on the card using the subject's subjective to help encourage maximal midline orientation. Permission will be obtained to text the subject on a regular basis to remind them to perform the exercises.
Session 2: Participants who choose to return will come back within 3 to 5 days of Session #1. Subjects will be asked to bring their HEP card to verify compliance via the practice log. After placement of the trajectory markers (but not the EMG), subjects will be asked to perform two trials of sit to stand, regardless of their original group. They will then be assessed with the AAOUT test in the same manner as the end of session #1. Afterward, participants in the Verbal Cueing group will be offered the Integrated Cueing approach if they so choose.
- Being tested
- Integrated Cueing Protocol, Verbal Cueing Protocol
- Keywords
- Facilitation, Sit-to-Stand, Manual Cueing, Verbal Cueing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Cueing ProtocolOther
Also called Manual Cueing Protocol
The first 5 repetitions will include part to whole task practice of partial sit to stand using scripted verbal cueing to facilitate understanding of the task. The goal is to improve midline orientation and alignment during the task of moving from sitting to standing. In addition to verbal cueing, the manual cueing group will receive hands-on tactile facilitation from a trained physical therapist to facilitate appropriate midline weight shift during the sit to stand activity for the series of 40 training repetitions.
Verbal Cueing ProtocolOther
The first 5 repetitions will include part to whole task practice of partial sit to stand using scripted verbal cueing to facilitate understanding of the task. The goal is to improve midline orientation and alignment during the task of moving from sitting to standing. The verbal cueing protocol consists of verbal cueing from a trained physical therapist to facilitate appropriate midline weight shift during the sit to stand activity for the series of 40 training repetitions.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Manual and Verbal Cueing Group | Experimental | A series of 40 training repetitions of sit to stand using the Integrated/Manual Cueing intervention. Receives: Other: Integrated Cueing Protocol |
| Verbal Cueing Group | Experimental | A series of 40 training repetitions of sit to stand using the Verbal Cueing intervention Receives: Other: Verbal Cueing Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Midline Orientation via Symmetry Ratio
The participant's ability to equally distribute their weight throughout the sit to stand task will be measured via two force plates integrated with the Qualisys motion capture system. The ratio is calculated via dividing the weight on the hemiparetic leg by the weight on the non-hemiparetic side. A score of 1 indicates equal weight bearing.
Measured: Baseline and immediately after the intervention
Midline Orientation via Trunk Lateral Lean angle
The participant's ability to maintain an upright trunk throughout the sit to stand task as measured by computations from the Qualisys motion capture system using 40 trajectory markers. Perfect midline orientation would be a value of 0 degrees indicating midline orientation.
Measured: Baseline and immediately after the intervention
Muscle Activation
Comparison of muscle activation between normal and hemiparetic lower extremity extensor muscle groups as measured with surface electromyography (EMG) and processed through the Qualisys motion capture system. Change will be indicated by subtracting max contraction per various extensor muscle groups as a composite measure during the activity from initial max contraction of the same muscle group.
Measured: During after the intervention
Time to complete Sit to Stand Activity
A measurement of the total elapsed time to perform the sit to stand activity as measured from initial movement to highest position of center of mass
Measured: Baseline and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start6 Nov 2020
- Primary completion24 Aug 2022
- Study completion24 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegia and/or Hemiparesis Following StrokeStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Johnson, Loma Linda University
- Investigators
- Eric G Johnson, DSc, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498429
- Sponsor's protocol ID
- 5200090
- Acronym
- EOIC
- Status last verified
- Feb 2024
- First submitted
- 28 Jul 2020
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Integrated Manual and Verbal Cueing on Functional Transfers in Chronic Stroke Survivors: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04498429
- Acronym / sponsor ID
- EOIC / 5200090
- Keywords
- Facilitation, Sit-to-Stand, Manual Cueing, Verbal Cueing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- 24 Aug 2022 (actual)
- Study completion
- 24 Aug 2022 (actual)
- First posted
- 4 Aug 2020 (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.
Physical therapists frequently use manual cueing as a tool to improve movement quality in persons recovering from stroke but evidence to support its effectiveness is lacking.
The purpose of this graduate student research study is to determine the immediate and carryover effects of an integrated verbal and manual facilitation approach used by physical therapists during sit to stand training on the midline alignment, muscle activation and quality of movement in chronic stroke survivors with hemiplegia.
Detailed description
Over the last few decades, the profession of physical therapy has heavily relied on manual facilitation to improve motor control and functional movement in persons recovering from stroke or other neurological impairments. In the 1950's, Berta Bobath created Neuro-Developmental Treatment (NDT), a systematic problem-solving approach that is one of the most widely used methodologies in neurorehabilitation. NDT relies heavily on verbal and tactile facilitation as an integrated approach to improve motor control in persons with hemiplegia. However, current systematic reviews have stated that adequate evidence for the effectiveness of neuro facilitation is lacking. In the current climate of evidence-based practice, neurologic physical therapists no longer blindly accept the use of traditional interventions and instead rely on peer-reviewed research studies to support their clinical decision-making.
However, the question remains for many physical therapists: are skilled manual cues really an essential ingredient in the post-stroke recipe? Most practicing neurologic physical therapists would claim that their hands are their most valuable tools and that the way in which they use their hands has a direct effect on movement patterns and functional outcomes with their patients. Ploughman and colleagues reported that manual tactile cues during gait had "robust but short-lived impacts on cadence and time in double support" during gait but their findings are merely a step in the right direction. An integrative approach of both manual and verbal cues have anecdotally shown to be effective to treat impairments from stroke but there continues to be a dearth of evidence to accurately support the pervasive use of manual facilitation by physical therapists. While support for manual tactile cueing is merely beginning to move in the right direction, strong evidence exists that task specific training can improve functional outcomes by focusing training on desired movements and activities. But what part does manual cueing truly play in task specific training? Sit to stand is an essential activity of daily living that is often impaired in stroke survivors and is commonly trained by physical therapists from both task specific training and NDT schools of thought. Physical therapists need further clarification as to which methods are most effective for facilitating maximum learning and recovery during this functional task in order to craft an ideal recipe.
Training correct movement patterns in order to improve functional independence is important at every stage of recovery after stroke. Kerr et al. suggested that successful sit to stand movements require proper training of the critical timing of events as well as improving synergistic activation of the appropriate lower limb musculature. Ultimately, asymmetry can lead to a conditioned suppression of available movement termed "learned non-use". Continual reinforcement of poor movement strategies thus leads to passive suppression of maximally efficient normal movements unless the stroke survivor is actively retrained to unlock masked abilities over time. Teasell and colleagues confirmed the importance of skilled rehabilitation throughout all phases of recovery including the chronic stroke phase, though this important population regularly experiences fewer opportunities to participate in therapy as time progresses. Measurable gains may be slower at this stage but the ability to perform essential mobility tasks remains just as important to the individual.
Thus, the purpose of this graduate student research study is to determine the immediate and carryover effects of an integrated verbal and manual facilitation approach during sit to stand training on the midline alignment, muscle activation and quality of movement in chronic stroke survivors with hemiplegia. By determining the essential ingredients that lead to an ideal recipe for success, physical therapists may have more evidence-based tools available to maximize the independence, quality of life and confidence of their patients.
Procedures: Session 1: All participants will complete the initial paperwork and then be randomized into Verbal Cueing Group or Verbal + Manual Cueing Group using envelopes that are predetermined from a random number table. Height will be assessed using a stadiometer and weight using a scale. Subjects will then have trajectory markers and surface electromyographic (EMG) sensors placed according to the chart. This includes 24 individual marker trajectories, two thigh clusters and two shank clusters of four trajectories each for a total of 40 markers and 6 surface EMG sensors that will be placed on major muscle groups of the lower extremities. Once the setup has been completed and verified, the subject will perform two static standing trials, followed by two initial sit to stand (STS) trials to determine their baseline variables. This format will be followed by both the Verbal Cueing and the Verbal + Manual Cueing throughout the treatment session. The first 5 repetitions of both groups will include part to whole task practice of partial sit to stand using scripted verbal cueing to facilitate understanding of the task. The goal of both groups is to improve midline orientation and alignment during the task of moving from sitting to standing.
After the first 5 repetitions, the subject will perform two sit to stand trials on their own following the clinician's scripted verbal commands. Next, five Manual + Verbal Cueing or Verbal Cueing trials will commence followed by another two PostCue trials. This repeated sequence of 5 cued trials followed by 2 assessment trials will continue for a total of 40 sit to stand trials. After a 5-minute rest period the subject will then be asked to perform two additional STS to determine retention of learning over that interval. Next, two isometrically resisted sit to stand trials will be performed for EMG normalization. Once the EMG normalization is completed, the subject will then be told they are done and may get up to leave. When they get up to leave, their sit to stand activity will also be discretely recorded for comparison to their last knowingly observed trial. This is based on the Actual Amount of Use Test (AAOUT) in which subjects are observed under normal circumstances to assess whether the learning was integrated into functional use when the subject doesn't think they are being observed.
At the end of session #1, the investigator will ask the subject what strategy most helped them achieve midline. Based on their feedback, the investigator will create and issue a home exercise program (HEP) handout that incorporates that subjective report. Examples include statements such as, "Feeling the pressure through my left leg" or "Leaning to my left". This cue will be placed on a brightly colored card that will be placed near where the subject practices sitting to standing most often in their home environment. The card will also contain an easy to mark log to encourage practice of the STS task over the next 3-5 days. The subject will be instructed to perform the exercises at the times specified on the card using the subject's subjective to help encourage maximal midline orientation. Permission will be obtained to text the subject on a regular basis to remind them to perform the exercises.
Session 2: Participants who choose to return will come back within 3 to 5 days of Session #1. Subjects will be asked to bring their HEP card to verify compliance via the practice log. After placement of the trajectory markers (but not the EMG), subjects will be asked to perform two trials of sit to stand, regardless of their original group. They will then be assessed with the AAOUT test in the same manner as the end of session #1. Afterward, participants in the Verbal Cueing group will be offered the Integrated Cueing approach if they so choose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Manual and Verbal Cueing Group | Experimental | Other: Integrated Cueing ProtocolA series of 40 training repetitions of sit to stand using the Integrated/Manual Cueing intervention. |
| Verbal Cueing Group | Experimental | Other: Verbal Cueing ProtocolA series of 40 training repetitions of sit to stand using the Verbal Cueing intervention |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic Right CVA with left hemiplegia > 6 Months
- Able to ambulate with no more than help than supervision
- Must be able to stand without an assistive device or ankle foot orthosis
- Must be able to follow two-step verbal commands
Key exclusion criteria (3 listed)
- History of injury from a recent fall within the last 3 months
- Currently participating in rehabilitation during the time frame of their participation in this study
- Additional musculoskeletal or neurological conditions that may impair ability to perform sit to stand safely
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 |
|---|---|---|
| Integrated Cueing ProtocolAlso: Manual Cueing ProtocolThe first 5 repetitions will include part to whole task practice of partial sit to stand using scripted verbal cueing to facilitate understanding of the task. The goal is to improve midline orientation and alignment during the task of moving from sitting to standing. In addition to verbal cueing, the manual cueing group will receive hands-on tactile facilitation from a trained physical therapist to facilitate appropriate midline weight shift during the sit to stand activity for the series of 40 training repetitions. | Other | Integrated Manual and Verbal Cueing Group |
| Verbal Cueing ProtocolThe first 5 repetitions will include part to whole task practice of partial sit to stand using scripted verbal cueing to facilitate understanding of the task. The goal is to improve midline orientation and alignment during the task of moving from sitting to standing. The verbal cueing protocol consists of verbal cueing from a trained physical therapist to facilitate appropriate midline weight shift during the sit to stand activity for the series of 40 training repetitions. | Other | Verbal Cueing Group |
Primary outcome
Midline Orientation via Symmetry Ratio
Time frame: Baseline and immediately after the intervention
The participant's ability to equally distribute their weight throughout the sit to stand task will be measured via two force plates integrated with the Qualisys motion capture system. The ratio is calculated via dividing the weight on the hemiparetic leg by the weight on the non-hemiparetic side. A score of 1 indicates equal weight bearing.
Midline Orientation via Trunk Lateral Lean angle
Time frame: Baseline and immediately after the intervention
The participant's ability to maintain an upright trunk throughout the sit to stand task as measured by computations from the Qualisys motion capture system using 40 trajectory markers. Perfect midline orientation would be a value of 0 degrees indicating midline orientation.
Muscle Activation
Time frame: During after the intervention
Comparison of muscle activation between normal and hemiparetic lower extremity extensor muscle groups as measured with surface electromyography (EMG) and processed through the Qualisys motion capture system. Change will be indicated by subtracting max contraction per various extensor muscle groups as a composite measure during the activity from initial max contraction of the same muscle group.
Time to complete Sit to Stand Activity
Time frame: Baseline and immediately after the intervention
A measurement of the total elapsed time to perform the sit to stand activity as measured from initial movement to highest position of center of mass
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 2 Feb 2024.
- Individual participant dataSharing planned: No. Individual data will not be shared
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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.
Eric G Johnson, DSc principal investigator
Loma Linda University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Cueing Protocol and Verbal Cueing Protocol in people with Hemiplegia and/or Hemiparesis Following Stroke, run by Loma Linda University at 2 sites 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 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: finished, as of the sponsor's last update on 2 Feb 2024. 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 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?
Midline Orientation via Symmetry Ratio (time frame: Baseline and immediately after the intervention). The study lists 4 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 2 Feb 2024.