StrokeNCT03425890
Effect of Self-empowered Upper Limb Repetitive Engagement (SURE) Program on Upper Limb Recovery After Stroke
A study testing SURE program in people with Stroke, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial summary
The aim of this study is to investigate the effect of SURE program on UL recovery during first few weeks post-stroke. A randomised blinded controlled pilot trial will be conducted. Twenty people with stroke will be randomly allocated to 4-weeks of SURE program or education program. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- SURE program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSingapore
- Study dates
- 2 Feb 2018to 20 Jun 2019
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of first-ever stroke occurring less than 21 days ago
- Positive motor evoked potential on affected hand extensor carpi radialis during Transcranial Magnetic Stimulation (TMS) investigation
- Clinically moderate to severe UL paresis (ULFM score of less than or equal to 50)
- Montreal Cognitive Assessment>= 19
Who cannot join
- Prior history of central nervous system disorders e.g. Parkinsonism, Spinal Cord Injury, previous stroke
- Structural brain lesions e.g. brain tumors
- Medical history of psychiatric disturbance e.g. schizophrenia
- Bilateral stroke
- Cardiac disease that limit function by exertional dyspnoea, angina or severe fatigue (defined by physicians and treating therapists)
- Hemiplegic shoulder pain VAS >5/10
Show all 9Show fewer
- Existing peripheral nerve or orthopaedic conditions that interfere with affected UL movement e.g. frozen shoulder, peripheral nerve damage to UL
- Severe aphasia, neglect, agitation, or depression (defined by physicians and treating therapists) that can limit participation
- Any contraindications to MRI and TMS.
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Tan Tock Seng Hospital Rehabilitation Centre
Singapore, 569766
About this study
Official title: The Effect of the Self-empowered Upper Limb Repetitive Engagement (SURE) Program on Upper Limb Recovery Compared With Education in People With Stroke Undergoing Inpatient Rehabilitation
The aim of this study is to investigate the effect of SURE program on UL recovery during first few weeks post-stroke. A randomised blinded controlled pilot trial will be conducted. Twenty people with stroke will be randomly allocated to 4-weeks of SURE program or education program. This is to perform on top of their usual care. To determine the clinical benefit, all participants will be assessed pre-, 2 weeks during the training, post-training, 1-month and 3-month follow-up using a range of impairment and activity measures. To determine the cortical activation (fMRI), structural (FLAIR and DTI) and functional (resting state fcMRI) connectivity of cortical motor regions, all participants will undergo a 3T MRI pre-, post- and post-3 months after training.
Read the detailed description
Background:
UL recovery after stroke has been found to be limited. Efforts should be channelled into rehabilitation to improve UL recovery after stroke. First 4-weeks post-stroke is the period when neuroplasticity unfolds and when most rehabilitation occurs. This critical time window should be capitalized to interact with spontaneous biological recovery to facilitate UL recovery. There is growing evidence that shows that early increased UL practice after stroke improves the recovery of upper limb function. However, it has also been found that the level of early UL practice and use during early post-stroke is low. SURE program is a self-exercise program which aims to empower people with stroke and their caregivers to increase early UL practice outside therapy.
Aim:
To investigate the effect of SURE program on UL recovery during first few weeks post-stroke.
Method:
A randomised blinded controlled pilot trial will be conducted. Twenty people with stroke will be randomly allocated to 4-weeks of SURE program or education program.
Intervention Group- SURE Program The intervention group will receive a SURE program booklet and will perform individualized daily self-exercise and functional use of the arm and hand on their own outside of therapy for 60 minutes/day, 6 days/week for 4 weeks. These self-exercises and upper limb functional use will be performed in addition to usual care. Three SURE program booklets have been developed which relate to the affected upper limb motor capability using individual Fugl Meyer (ULFM) score. Each SURE program booklet consists of warm-up exercises, strengthening exercises and motor tasks. The SURE program booklet also includes selected functional motor tasks to be performed by the participants using their affected upper limb. The performance of the exercises and functional motor tasks will be reviewed three times per week for the first 2 weeks, two times for the third week and one time for the fourth week of intervention period.
Control Group- Education The control group will receive an education booklet with 10 modules. The education booklet will contain information on stroke, recovery and management strategies after stroke. Participants are to complete 2-3 modules per week and answer 1-2 simple questions after each module. Each module including answering questions takes approximately 5-10 minutes to complete. CPI will review the information with the participants 3 times per week for the first 2 weeks, two times for the third week and one time for the fourth week of intervention period.The participants in the control group will continue with their usual care in the hospital.
To determine the clinical benefit, all participants will be assessed pre-, 2 weeks during the training, post-training, 1-month and 3-month follow-up using a range of impairment and activity measures. To determine the cortical activation (fMRI), structural (FLAIR and DTI) and functional (resting state fcMRI) connectivity of cortical motor regions, all participants will undergo a 3T MRI pre-, post- and post-3 months after training.
- Conditions
- Stroke
- Being tested
- SURE program
- Keywords
- Upper Limb, Self-exercise
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SURE programBehavioural
SURE program is a self-exercise program which aims to empower people with stroke and their caregivers to increase early UL practice outside therapy
| Study group | Role | What they receive |
|---|---|---|
| SURE Program Group | Experimental | The intervention group will receive a SURE program booklet and will perform individualized daily self-exercise and functional use of the arm and hand on their own outside of therapy for 60 minutes/day, 6 days/week for 4 weeks. These self-exercises and upper limb functional use will be performed in addition to usual care. Three SURE program booklets have been developed which relate to the affected upper limb motor capability using individual Fugl Meyer (ULFM) score. Each SURE program booklet consists of warm-up exercises, strengthening exercises and motor tasks. The SURE program booklet also includes selected functional motor tasks to be performed by the participants using their affected upper limb. The performance of the exercises and functional motor tasks will be reviewed three times per week for the first 2 weeks, two times for the third week and one time for the fourth week of intervention period. Receives: Behavioral: SURE program |
| Education Group | Experimental | The control group will receive an education booklet with 10 modules. The education booklet will contain information on stroke, recovery and management strategies after stroke. Participants are to complete 2-3 modules per week and answer 1-2 simple questions after each module. Each module including answering questions takes approximately 5-10 minutes to complete. CPI will review the information with the participants 3 times per week for the first 2 weeks, two times for the third week and one time for the fourth week of intervention period.The participants in the control group will continue with their usual care in the hospital. Receives: Behavioral: SURE program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Upper Limb Fugl Meyer Scale (ULFM)
Change of Upper Limb Motor Impairment
Measured: Change from pre training to immediate post training
Secondary outcomes (26)
Change of Upper Limb Fugl Meyer Scale (ULFM)
Change of Upper Limb Motor Impairment
Measured: Change from pre training to 2 weeks into training
Change of Upper Limb Fugl Meyer Scale (ULFM)
Change of Upper Limb Motor Impairment
Measured: Change from 2 weeks into training to immediate post-training
Change of Upper Limb Fugl Meyer Scale (ULFM)
Change of Upper Limb Motor Impairment
Measured: Change from immediate post training to 1-month post-training
Change of Upper Limb Fugl Meyer Scale (ULFM)
Change of Upper Limb Motor Impairment
Measured: Change from 1-month post-training to 3 month post-training
Change of Action Research Arm Test (ARAT)
Change of Upper Limb Functional Outcome
Measured: Change from pre training to 2 weeks into training
Change of Action Research Arm Test (ARAT)
Change of Upper Limb Functional Outcome
Measured: Change from 2 weeks into training to immediate post training
Change of Action Research Arm Test (ARAT)
Change of Upper Limb Functional Outcome
Measured: Change from immediate post training to 1-month post training
Change of Action Research Arm Test (ARAT)
Change of Upper Limb Functional Outcome
Measured: Change from 1-month post training to 3-month post training
Rating of Everyday Arm-Use in the Community and Home (REACH)
Measure real-world use of the arm in everyday tasks
Measured: Measure at 1-month post training
Rating of Everyday Arm-Use in the Community and Home (REACH)
Measure real-world use of the arm in everyday tasks
Measured: Measure at 3-month post training
Stanford Fatigue Visual Numeric Scale (FVNS)
Measure Fatigue Level from 0 point (minimum) to 10 points (maximum) (the higher the score, the more fatigue the participant experience)
Measured: Measure at pre training
Stanford Fatigue Visual Numeric Scale (FVNS)
Measure Fatigue Level from 0 point (minimum) to 10 points (maximum) (the higher the score, the more fatigue the participant experience)
Measured: Measure at 2 weeks into training
Stanford Fatigue Visual Numeric Scale (FVNS)
Measure Fatigue Level from 0 point (minimum) to 10 points (maximum) (the higher the score, the more fatigue the participant experience)
Measured: Measure immediate post training
Visual Analogue Scale (VAS)
Measure Affected UL Pain from 0 point (minimum) to 10 points (maximum) (the higher the score, the more pain the participant experience)
Measured: Measure at pre training
Visual Analogue Scale (VAS)
Measure Affected UL Pain from 0 point (minimum) to 10 points (maximum) (the higher the score, the more pain the participant experience)
Measured: Measure at 2 weeks into training
Visual Analogue Scale (VAS)
Measure Affected UL Pain from 0 point (minimum) to 10 points (maximum) (the higher the score, the more pain the participant experience)
Measured: Measure at immediate post training
Modified Ashworth Scale (MAS)
Measure tone of Affected UL biceps from 0- point (minimum) to 4 points (maximum) (the higher the score, the higher the muscle tone)
Measured: Measure at pre training
Modified Ashworth Scale (MAS)
Measure tone of Affected UL biceps from 0- point (minimum) to 4 points (maximum) (the higher the score, the higher the muscle tone)
Measured: Measure at 2 weeks into training
Modified Ashworth Scale (MAS)
Measure tone of Affected UL biceps from 0- point (minimum) to 4 points (maximum) (the higher the score, the higher the muscle tone)
Measured: Measure at immediate post training
Duration of Affected Upper Limb activity in hours
Measure Duration of Affected Upper Limb activity in hours using Actigraph GT3X-BT wrist accelerometer
Measured: Measure at 1 week into training
Duration of Affected Upper Limb activity in hours
Measure Duration of Affected Upper Limb activity in hours using Actigraph GT3X-BT wrist accelerometer
Measured: Measure at 2 weeks into training
Duration of Affected Upper Limb activity in hours
Measure Duration of Affected Upper Limb activity in hours using Actigraph GT3X-BT wrist accelerometer
Measured: Measure at 3 weeks into training
Duration of Affected Upper Limb activity in hours
Measure Duration of Affected Upper Limb activity in hours using Actigraph GT3X-BT wrist accelerometer
Measured: Measure at 4 weeks 4 into training
Bilateral Motor Cortex Brain Activation
Measuring bilateral motor cortex cortical activation using functional Magnetic Resonance Imaging using a 3T MRI
Measured: Measure at pre training
Bilateral Motor Cortex Brain Activation
Measuring bilateral motor cortex cortical activation using functional Magnetic Resonance Imaging using a 3T MRI
Measured: Measure at immediate post training
Bilateral Motor Cortex Brain Activation
Measuring bilateral motor cortex cortical activation using functional Magnetic Resonance Imaging using a 3T MRI
Measured: Measure at 3-month post training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start2 Feb 2018
- Primary completion29 Mar 2019
- Study completion20 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Blinded Controlled Pilot Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore, National University Hospital, Singapore
- Responsible party
- Principal investigator, Chin Lay Fong, Tan Tock Seng Hospital
- Investigators
- Lay Fong Chin, Masters, Principal investigator, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425890
- Sponsor's protocol ID
- 2016/00600
- Other IDs
- 2016
- Status last verified
- Aug 2019
- First submitted
- 25 Jan 2018
- Last updated
- 3 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participants data to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Self-empowered Upper Limb Repetitive Engagement (SURE) Program on Upper Limb Recovery Compared With Education in People With Stroke Undergoing Inpatient Rehabilitation
- ClinicalTrials.gov ID
- NCT03425890
- Acronym / sponsor ID
- 2016/00600
- Conditions
- Stroke
- Keywords
- Upper Limb, Self-exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Collaborators
- National University of Singapore, National University Hospital, Singapore
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 29 Mar 2019 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 8 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the effect of SURE program on UL recovery during first few weeks post-stroke. A randomised blinded controlled pilot trial will be conducted. Twenty people with stroke will be randomly allocated to 4-weeks of SURE program or education program. This is to perform on top of their usual care. To determine the clinical benefit, all participants will be assessed pre-, 2 weeks during the training, post-training, 1-month and 3-month follow-up using a range of impairment and activity measures. To determine the cortical activation (fMRI), structural (FLAIR and DTI) and functional (resting state fcMRI) connectivity of cortical motor regions, all participants will undergo a 3T MRI pre-, post- and post-3 months after training.
Detailed description
Background:
UL recovery after stroke has been found to be limited. Efforts should be channelled into rehabilitation to improve UL recovery after stroke. First 4-weeks post-stroke is the period when neuroplasticity unfolds and when most rehabilitation occurs. This critical time window should be capitalized to interact with spontaneous biological recovery to facilitate UL recovery. There is growing evidence that shows that early increased UL practice after stroke improves the recovery of upper limb function. However, it has also been found that the level of early UL practice and use during early post-stroke is low. SURE program is a self-exercise program which aims to empower people with stroke and their caregivers to increase early UL practice outside therapy.
Aim:
To investigate the effect of SURE program on UL recovery during first few weeks post-stroke.
Method:
A randomised blinded controlled pilot trial will be conducted. Twenty people with stroke will be randomly allocated to 4-weeks of SURE program or education program.
Intervention Group- SURE Program The intervention group will receive a SURE program booklet and will perform individualized daily self-exercise and functional use of the arm and hand on their own outside of therapy for 60 minutes/day, 6 days/week for 4 weeks. These self-exercises and upper limb functional use will be performed in addition to usual care. Three SURE program booklets have been developed which relate to the affected upper limb motor capability using individual Fugl Meyer (ULFM) score. Each SURE program booklet consists of warm-up exercises, strengthening exercises and motor tasks. The SURE program booklet also includes selected functional motor tasks to be performed by the participants using their affected upper limb. The performance of the exercises and functional motor tasks will be reviewed three times per week for the first 2 weeks, two times for the third week and one time for the fourth week of intervention period.
Control Group- Education The control group will receive an education booklet with 10 modules. The education booklet will contain information on stroke, recovery and management strategies after stroke. Participants are to complete 2-3 modules per week and answer 1-2 simple questions after each module. Each module including answering questions takes approximately 5-10 minutes to complete. CPI will review the information with the participants 3 times per week for the first 2 weeks, two times for the third week and one time for the fourth week of intervention period.The participants in the control group will continue with their usual care in the hospital.
To determine the clinical benefit, all participants will be assessed pre-, 2 weeks during the training, post-training, 1-month and 3-month follow-up using a range of impairment and activity measures. To determine the cortical activation (fMRI), structural (FLAIR and DTI) and functional (resting state fcMRI) connectivity of cortical motor regions, all participants will undergo a 3T MRI pre-, post- and post-3 months after training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised Blinded Controlled Pilot Trial
| Arm | Type | Receives |
|---|---|---|
| SURE Program Group | Experimental | Behavioral: SURE programThe intervention group will receive a SURE program booklet and will perform individualized daily self-exercise and functional use of the arm and hand on their own outside of therapy for 60 minutes/day, 6 days/week for 4 weeks. These self-exercises and upper limb functional use will be performed in addition to usual care. Three SURE program booklets have been developed which relate to the affected upper limb motor capability using individual Fugl Meyer (ULFM) score. Each SURE program booklet consists of warm-up exercises, strengthening exercises and motor tasks. The SURE program booklet also includes selected functional motor tasks to be performed by the participants using their affected upper limb. The performance of the exercises and functional motor tasks will be reviewed three times per week for the first 2 weeks, two times for the third week and one time for the fourth week of intervention period. |
| Education Group | Experimental | Behavioral: SURE programThe control group will receive an education booklet with 10 modules. The education booklet will contain information on stroke, recovery and management strategies after stroke. Participants are to complete 2-3 modules per week and answer 1-2 simple questions after each module. Each module including answering questions takes approximately 5-10 minutes to complete. CPI will review the information with the participants 3 times per week for the first 2 weeks, two times for the third week and one time for the fourth week of intervention period.The participants in the control group will continue with their usual care in the hospital. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of first-ever stroke occurring less than 21 days ago
- Positive motor evoked potential on affected hand extensor carpi radialis during Transcranial Magnetic Stimulation (TMS) investigation
- Clinically moderate to severe UL paresis (ULFM score of less than or equal to 50)
- Montreal Cognitive Assessment>= 19
Key exclusion criteria (9 listed)
- Prior history of central nervous system disorders e.g. Parkinsonism, Spinal Cord Injury, previous stroke
- Structural brain lesions e.g. brain tumors
- Medical history of psychiatric disturbance e.g. schizophrenia
- Bilateral stroke
- Cardiac disease that limit function by exertional dyspnoea, angina or severe fatigue (defined by physicians and treating therapists)
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 |
|---|---|---|
| SURE programSURE program is a self-exercise program which aims to empower people with stroke and their caregivers to increase early UL practice outside therapy | Behavioural | Education Group, SURE Program Group |
Primary outcome
Change of Upper Limb Fugl Meyer Scale (ULFM)
Time frame: Change from pre training to immediate post training
Change of Upper Limb Motor Impairment
26 secondary outcomes
Change of Upper Limb Fugl Meyer Scale (ULFM)
Time frame: Change from pre training to 2 weeks into training
Change of Upper Limb Fugl Meyer Scale (ULFM)
Time frame: Change from 2 weeks into training to immediate post-training
Change of Upper Limb Fugl Meyer Scale (ULFM)
Time frame: Change from immediate post training to 1-month post-training
Change of Upper Limb Fugl Meyer Scale (ULFM)
Time frame: Change from 1-month post-training to 3 month post-training
Change of Action Research Arm Test (ARAT)
Time frame: Change from pre training to 2 weeks into training
Change of Action Research Arm Test (ARAT)
Time frame: Change from 2 weeks into training to immediate post training
Change of Action Research Arm Test (ARAT)
Time frame: Change from immediate post training to 1-month post training
Change of Action Research Arm Test (ARAT)
Time frame: Change from 1-month post training to 3-month post training
Rating of Everyday Arm-Use in the Community and Home (REACH)
Time frame: Measure at 1-month post training
Rating of Everyday Arm-Use in the Community and Home (REACH)
Time frame: Measure at 3-month post training
Stanford Fatigue Visual Numeric Scale (FVNS)
Time frame: Measure at pre training
Stanford Fatigue Visual Numeric Scale (FVNS)
Time frame: Measure at 2 weeks into training
Stanford Fatigue Visual Numeric Scale (FVNS)
Time frame: Measure immediate post training
Visual Analogue Scale (VAS)
Time frame: Measure at pre training
Visual Analogue Scale (VAS)
Time frame: Measure at 2 weeks into training
Visual Analogue Scale (VAS)
Time frame: Measure at immediate post training
Modified Ashworth Scale (MAS)
Time frame: Measure at pre training
Modified Ashworth Scale (MAS)
Time frame: Measure at 2 weeks into training
Modified Ashworth Scale (MAS)
Time frame: Measure at immediate post training
Duration of Affected Upper Limb activity in hours
Time frame: Measure at 1 week into training
Duration of Affected Upper Limb activity in hours
Time frame: Measure at 2 weeks into training
Duration of Affected Upper Limb activity in hours
Time frame: Measure at 3 weeks into training
Duration of Affected Upper Limb activity in hours
Time frame: Measure at 4 weeks 4 into training
Bilateral Motor Cortex Brain Activation
Time frame: Measure at pre training
Bilateral Motor Cortex Brain Activation
Time frame: Measure at immediate post training
Bilateral Motor Cortex Brain Activation
Time frame: Measure at 3-month post training
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 Sep 2019.
- Individual participant dataSharing planned: No. No plan to share individual participants data to other researchers
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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.
Lay Fong Chin, Masters principal investigator
Tan Tock Seng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SURE program in people with Stroke, run by Tan Tock Seng Hospital at 1 site in Singapore.
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 9 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 Sep 2019. 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 Singapore. 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?
Change of Upper Limb Fugl Meyer Scale (ULFM) (time frame: Change from pre training to immediate post training). 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 Sep 2019.