Cerebral InfarctionLASTNCT01467206
Life After STroke - the LAST Study
A study testing Long term follow up by a coordinating physiotherapist in people with Cerebral Infarction and Cerebral Hemorrhage, run by Norwegian University of Science and Technology at 2 sites in Norway.
Trial summary
The LAST study is a Norwegian multi site randomised controlled trial that intends to assess the effect of a long term follow up program after stroke. The program consists of a coordinating physiotherapist who will encourage and motivate included patients to perform at least 60 minutes of intensive motor training every… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Cerebral Infarction, Cerebral Hemorrhage
- What is being tested?
- Long term follow up by a coordinating physiotherapist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 2 sitesNorway
- Study dates
- Nov 2011to Dec 2015
- 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of stroke according to WHO's definition of stroke
- Living in the city of Trondheim or the municipalities of Asker or Bærum
- Included 2.5 - 4 months after stroke
- Modified Rankin Scale 0 - 4
- Living at home
- Mini Mental State Examination > 20 or > 16 if aphasia
- Provide informed consent
Who cannot join
- Are already included in the study
- Are included in other experimental studies
- Unstable coronary function
- Uncompensated heartfailure
- Other diseases that make it difficult to complete the intervention
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Life After STroke - the LAST Study. A Norwegian Multi Centre Randomized Controlled Trial
The LAST study is a Norwegian multi site randomised controlled trial that intends to assess the effect of a long term follow up program after stroke. The program consists of a coordinating physiotherapist who will encourage and motivate included patients to perform at least 60 minutes of intensive motor training every week and 30 minutes of physical activity every day for 18 months after inclusion. The primary hypothesis is that patients receiving a long term follow up program after stroke will have better motor function at end of follow up than patients receiving standard care. A total of 390 home dwelling stroke patients living in the municipality of Trondheim, Asker and Bærum will be included at the out-patient clinic at St. Olavs Hospital or Bærum Hospital three months after their stroke. Included patients will be randomised to an intervention group receiving the long term follow up program or to a control group receiving standard care. Motor function, mental health and physical functioning in daily life will be assessed at inclusion and 18 months later. The LAST study is funded by the Norwegian Research Council, the Norwegian University of Science and Technology and the Central Norway Regional Health Authority and will conclude at the end of 2015.
Read the detailed description
Supplement to the Life After Stroke - the LAST study ClinicalTrials.gov ID: NCT01467206
Changes in the planned statistical analysis, November 9, 2015 The original plan for statistical analysis was published in; Askim T, Langhammer B, Ihle-Hansen H, Magnussen J, Engstad T, Indredavik B. A Long-Term Follow-Up Programme for Maintenance of Motor Function after Stroke: Protocol of the life after Stroke-The LAST Study. Stroke Res Treat. 2012;2012:392101. doi: 10.1155/2012/392101. Epub 2012 Nov 22.
Original plan for statistical analysis Reporting will follow the CONSORT statement for parallel group randomized trials [40]. Descriptive statistics will be performed in order to present the population and the characteristic of the two groups. All analyses will be analysed as intention-to-treat analysis according to the CONSORT instructions. Analysis of covariance (ANCOVA) will be used to study differences between groups according to the primary endpoint, motor assessment scale at 18 months after inclusion. The ANCOVA model will include stroke severity, age, pre stroke disability, treatment group, and motor function at baseline as covariates. Mann-Whitney U test will be used for secondary data not being normal distributed. In all analyses we will control for potential confounding factors, investigate effect modifications, and present both unadjusted and adjusted effects with 95% confidence intervals.
Subanalysis will be performed according to the stratification variables (stroke severity, age above 80 and recruitment site) to explore trends within subgroups of patients.
Revised plan for statistical analysis Reporting will follow the CONSORT statement for parallel group randomized trials [40]. Descriptive statistics will be performed in order to present the population and the characteristic of the two groups. All analyses will be analysed as intention-to-treat analysis according to the CONSORT instructions. Analysis of covariance (ANCOVA) will be used to study differences between groups according to the primary endpoint, motor assessment scale at 18 months after inclusion. The ANCOVA model will include stroke severity, age, pre stroke disability, treatment group, and motor function at baseline as covariates. Similar ANCOVA analyses will be used for the relevant secondary endpoints. Mann-Whitney U test will be used for secondary data not being normal distributed.
Subanalysis will be performed according to the stratification variables (stroke severity, age above 80 and recruitment site), gender, and cognitive status (Mini Mental State below 25), to explore trends within subgroups of patients.
Missing values will be handled using single imputation (typically for items on instrument scales), or by multiple imputation, as appropriate.
- Conditions
- Cerebral Infarction, Cerebral Hemorrhage
- Being tested
- Long term follow up by a coordinating physiotherapist, Standard care
- Keywords
- Stroke, Physiotherapy, Motor training, Rehabilitation
- Medical subject headings
- Cerebral Infarction, Cerebral Hemorrhage, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long term follow up by a coordinating physiotherapistBehavioural
Monthly meetings with an coordinating physiotherapist who motivate and encourage the patient to do 60 minutes of weekly exercise and 30 minutes of daily physical activity
Standard careBehavioural
Standard care as it is given to all stoke patients after stroke
| Study group | Role | What they receive |
|---|---|---|
| Long term follow up program | Experimental | Not described Receives: Behavioral: Long term follow up by a coordinating physiotherapist |
| Standard care | Active comparator | Not described Receives: Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Assessment Scale
A measure of over all motor function
Measured: 18 months after inclusion
Secondary outcomes (28)
Barthel Index
A measure of activities of daily living
Measured: 18 months follow up
Modified Rankin Scale
A measure of dependency/independency
Measured: 18 months follow up
Berg Balance Scale
A measure of balance related to basic movement tasks
Measured: 18 months follow up
Timed Up and Go
A measure of balance related to transfer and walking
Measured: 18 months follow up
Sit to stand test
A measure of dynamic muscle strength according to a sit to stand task
Measured: 18 months follow up
Six minute walk test
A measure of endurance
Measured: 18 months follow up
Stroke Impact Scale
A measure of health related quality of life after stroke
Measured: 18 months follow up
EuroQol 5D
A simple measure of health related quality of life for the general population
Measured: 18 months follow up
Fatigue Severity Scale
A measure of the presence of fatigue
Measured: 18 months follow up
One simple question on fatigue from the HUNT3 questionnaire
A simple question used to assess tiredness in teh general Norwegian population
Measured: 18 months follow up
Hospital Anxiety and Depression Scale
A measure of anxiety and depression
Measured: 18 months follow up
Mini Mental State Examination
A measure of cognitive function
Measured: 18 months follow up
Montreal Cognitive Assessment
A measure of cognitive function related to vascular dementia
Measured: 18 months follow up
falls
Serious falls will be recorded from the patients hospital records
Measured: 6, 12 and 18 months
Readmission to hospital
Number of readmissions to hospital will be recorded from the patients medical records
Measured: 6, 12 and 18 months
Death
Information about death will be collected from the Norwegain Death Registry
Measured: 6, 12 and 18 months
Fractures
Information about fractures during follow up will be collected from the patients medical records
Measured: 6, 12 and 18 months
Cardiovascular events
Information about any cardiovascular events will be collected from the patients medical record
Measured: 6, 12 and 18 months
Cerebrovascular events
Information about any cerebrovascular events during follow up will be collected from teh patient's medical records
Measured: 6, 12 and 18 months
International Physical Activity Questionnaire
A measure of physical activity over the last week
Measured: 6, 12 and 18 months
Physical activity assessed by ActivPAL sensor system
A sensor system to assess the amount of physical activity during a 4-7 day period
Measured: 6, 12 and 18 months
Three simple questions on physical activity from the HUNT questionnaire
A simple measure of physical activity
Measured: 18 months
Health costs
Information about the use of health services will be collected by reviewing the patients' hospital records and records in primary health care system.
Measured: 6, 12 and 18 months
National Institutes of Health Stroke Scale
A measure of stroke severity
Measured: 18 months follow up
Modified Ashworth Scale
A measure to rate the degree of spasticity after stroke
Measured: 18 months follow up
Gait speed
A simple measure of maximum gait speed across a 10 metres distance
Measured: 18 months follow up
Trailmaking test A and B
A simple measure of executive cognitive function
Measured: 18 months follow up
DS-14
A standard assessment of negative affectivity, social inhibition, and type D personality, which might be related to poor cardiovascular prognosis.
Measured: 18 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cerebral InfarctionStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Asker & Baerum Hospital, The Research Council of Norway, Helse Midt-Norge
- Responsible party
- Sponsor
- Investigators
- Bent Indredavik, Prof, Study director, National Taiwan Normal UniversityTorunn Askim, PhD, Principal investigator, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467206
- Sponsor's protocol ID
- 205309/H10
- Acronym
- LAST
- Status last verified
- Apr 2020
- First submitted
- 31 Oct 2011
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Askim T, Langhammer B, Ihle-Hansen H, Magnussen J, Engstad T, Indredavik B. A Long-Term Follow-Up Programme for Maintenance of Motor Function after Stroke: Protocol of the life after Stroke-The LAST Study. Stroke Res Treat. 2012;2012:392101. doi: 10.1155/2012/392101. Epub 2012 Nov 22.
PubMed 23227428Askim T, Langhammer B, Ihle-Hansen H, Gunnes M, Lydersen S, Indredavik B; LAST Collaboration Group. Efficacy and Safety of Individualized Coaching After Stroke: the LAST Study (Life After Stroke): A Pragmatic Randomized Controlled Trial. Stroke. 2018 Feb;49(2):426-432. doi: 10.1161/STROKEAHA.117.018827. Epub 2017 Dec 28.
PubMed 29284737Dohl O, Halsteinli V, Askim T, Gunnes M, Ihle-Hansen H, Indredavik B, Langhammer B, Phan A, Magnussen J. Factors contributing to post-stroke health care utilization and costs, secondary results from the life after stroke (LAST) study. BMC Health Serv Res. 2020 Apr 6;20(1):288. doi: 10.1186/s12913-020-05158-w.
PubMed 32252739Saunders DH, Mead GE, Fitzsimons C, Kelly P, van Wijck F, Verschuren O, Backx K, English C. Interventions for reducing sedentary behaviour in people with stroke. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD012996. doi: 10.1002/14651858.CD012996.pub2.
PubMed 34184251Gunnes M, Indredavik B, Langhammer B, Lydersen S, Ihle-Hansen H, Dahl AE, Askim T; LAST Collaboration group. Associations Between Adherence to the Physical Activity and Exercise Program Applied in the LAST Study and Functional Recovery After Stroke. Arch Phys Med Rehabil. 2019 Dec;100(12):2251-2259. doi: 10.1016/j.apmr.2019.04.023. Epub 2019 Jul 30.
PubMed 31374191
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Life After STroke - the LAST Study. A Norwegian Multi Centre Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01467206
- Acronym / sponsor ID
- LAST / 205309/H10
- Conditions
- Cerebral Infarction, Cerebral Hemorrhage
- Keywords
- Stroke, Physiotherapy, Motor training, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Asker & Baerum Hospital, The Research Council of Norway, Helse Midt-Norge
- Study start
- Nov 2011 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Nov 2011 (estimated)
- 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 LAST study is a Norwegian multi site randomised controlled trial that intends to assess the effect of a long term follow up program after stroke. The program consists of a coordinating physiotherapist who will encourage and motivate included patients to perform at least 60 minutes of intensive motor training every week and 30 minutes of physical activity every day for 18 months after inclusion. The primary hypothesis is that patients receiving a long term follow up program after stroke will have better motor function at end of follow up than patients receiving standard care. A total of 390 home dwelling stroke patients living in the municipality of Trondheim, Asker and Bærum will be included at the out-patient clinic at St. Olavs Hospital or Bærum Hospital three months after their stroke. Included patients will be randomised to an intervention group receiving the long term follow up program or to a control group receiving standard care. Motor function, mental health and physical functioning in daily life will be assessed at inclusion and 18 months later. The LAST study is funded by the Norwegian Research Council, the Norwegian University of Science and Technology and the Central Norway Regional Health Authority and will conclude at the end of 2015.
Detailed description
Supplement to the Life After Stroke - the LAST study ClinicalTrials.gov ID: NCT01467206
Changes in the planned statistical analysis, November 9, 2015 The original plan for statistical analysis was published in; Askim T, Langhammer B, Ihle-Hansen H, Magnussen J, Engstad T, Indredavik B. A Long-Term Follow-Up Programme for Maintenance of Motor Function after Stroke: Protocol of the life after Stroke-The LAST Study. Stroke Res Treat. 2012;2012:392101. doi: 10.1155/2012/392101. Epub 2012 Nov 22.
Original plan for statistical analysis Reporting will follow the CONSORT statement for parallel group randomized trials [40]. Descriptive statistics will be performed in order to present the population and the characteristic of the two groups. All analyses will be analysed as intention-to-treat analysis according to the CONSORT instructions. Analysis of covariance (ANCOVA) will be used to study differences between groups according to the primary endpoint, motor assessment scale at 18 months after inclusion. The ANCOVA model will include stroke severity, age, pre stroke disability, treatment group, and motor function at baseline as covariates. Mann-Whitney U test will be used for secondary data not being normal distributed. In all analyses we will control for potential confounding factors, investigate effect modifications, and present both unadjusted and adjusted effects with 95% confidence intervals.
Subanalysis will be performed according to the stratification variables (stroke severity, age above 80 and recruitment site) to explore trends within subgroups of patients.
Revised plan for statistical analysis Reporting will follow the CONSORT statement for parallel group randomized trials [40]. Descriptive statistics will be performed in order to present the population and the characteristic of the two groups. All analyses will be analysed as intention-to-treat analysis according to the CONSORT instructions. Analysis of covariance (ANCOVA) will be used to study differences between groups according to the primary endpoint, motor assessment scale at 18 months after inclusion. The ANCOVA model will include stroke severity, age, pre stroke disability, treatment group, and motor function at baseline as covariates. Similar ANCOVA analyses will be used for the relevant secondary endpoints. Mann-Whitney U test will be used for secondary data not being normal distributed.
Subanalysis will be performed according to the stratification variables (stroke severity, age above 80 and recruitment site), gender, and cognitive status (Mini Mental State below 25), to explore trends within subgroups of patients.
Missing values will be handled using single imputation (typically for items on instrument scales), or by multiple imputation, as appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long term follow up program | Experimental | Behavioral: Long term follow up by a coordinating physiotherapist |
| Standard care | Active comparator | Behavioral: Standard care |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of stroke according to WHO's definition of stroke
- Living in the city of Trondheim or the municipalities of Asker or Bærum
- Included 2.5 - 4 months after stroke
- Modified Rankin Scale 0 - 4
- Living at home
Key exclusion criteria (5 listed)
- Are already included in the study
- Are included in other experimental studies
- Unstable coronary function
- Uncompensated heartfailure
- Other diseases that make it difficult to complete the intervention
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 |
|---|---|---|
| Long term follow up by a coordinating physiotherapistMonthly meetings with an coordinating physiotherapist who motivate and encourage the patient to do 60 minutes of weekly exercise and 30 minutes of daily physical activity | Behavioural | Long term follow up program |
| Standard careStandard care as it is given to all stoke patients after stroke | Behavioural | Standard care |
Primary outcome
Motor Assessment Scale
Time frame: 18 months after inclusion
A measure of over all motor function
28 secondary outcomes
Barthel Index
Time frame: 18 months follow up
Modified Rankin Scale
Time frame: 18 months follow up
Berg Balance Scale
Time frame: 18 months follow up
Timed Up and Go
Time frame: 18 months follow up
Sit to stand test
Time frame: 18 months follow up
Six minute walk test
Time frame: 18 months follow up
Stroke Impact Scale
Time frame: 18 months follow up
EuroQol 5D
Time frame: 18 months follow up
Fatigue Severity Scale
Time frame: 18 months follow up
One simple question on fatigue from the HUNT3 questionnaire
Time frame: 18 months follow up
Hospital Anxiety and Depression Scale
Time frame: 18 months follow up
Mini Mental State Examination
Time frame: 18 months follow up
Montreal Cognitive Assessment
Time frame: 18 months follow up
falls
Time frame: 6, 12 and 18 months
Readmission to hospital
Time frame: 6, 12 and 18 months
Death
Time frame: 6, 12 and 18 months
Fractures
Time frame: 6, 12 and 18 months
Cardiovascular events
Time frame: 6, 12 and 18 months
Cerebrovascular events
Time frame: 6, 12 and 18 months
International Physical Activity Questionnaire
Time frame: 6, 12 and 18 months
Physical activity assessed by ActivPAL sensor system
Time frame: 6, 12 and 18 months
Three simple questions on physical activity from the HUNT questionnaire
Time frame: 18 months
Health costs
Time frame: 6, 12 and 18 months
National Institutes of Health Stroke Scale
Time frame: 18 months follow up
Modified Ashworth Scale
Time frame: 18 months follow up
Gait speed
Time frame: 18 months follow up
Trailmaking test A and B
Time frame: 18 months follow up
DS-14
Time frame: 18 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Background: PubMed 23227428Askim T, Langhammer B, Ihle-Hansen H, Magnussen J, Engstad T, Indredavik B. A Long-Term Follow-Up Programme for Maintenance of Motor Function after Stroke: Protocol of the life after Stroke-The LAST Study. Stroke Res Treat. 2012;2012:392101. doi: 10.1155/2012/392101. Epub 2012 Nov 22.
- Results publication: PubMed 29284737Askim T, Langhammer B, Ihle-Hansen H, Gunnes M, Lydersen S, Indredavik B; LAST Collaboration Group. Efficacy and Safety of Individualized Coaching After Stroke: the LAST Study (Life After Stroke): A Pragmatic Randomized Controlled Trial. Stroke. 2018 Feb;49(2):426-432. doi: 10.1161/STROKEAHA.117.018827. Epub 2017 Dec 28.
- Results publication: PubMed 32252739Dohl O, Halsteinli V, Askim T, Gunnes M, Ihle-Hansen H, Indredavik B, Langhammer B, Phan A, Magnussen J. Factors contributing to post-stroke health care utilization and costs, secondary results from the life after stroke (LAST) study. BMC Health Serv Res. 2020 Apr 6;20(1):288. doi: 10.1186/s12913-020-05158-w.
- Derived from this study: PubMed 34184251Saunders DH, Mead GE, Fitzsimons C, Kelly P, van Wijck F, Verschuren O, Backx K, English C. Interventions for reducing sedentary behaviour in people with stroke. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD012996. doi: 10.1002/14651858.CD012996.pub2.
- Derived from this study: PubMed 31374191Gunnes M, Indredavik B, Langhammer B, Lydersen S, Ihle-Hansen H, Dahl AE, Askim T; LAST Collaboration group. Associations Between Adherence to the Physical Activity and Exercise Program Applied in the LAST Study and Functional Recovery After Stroke. Arch Phys Med Rehabil. 2019 Dec;100(12):2251-2259. doi: 10.1016/j.apmr.2019.04.023. Epub 2019 Jul 30.
Related trials for Cerebral Infarction
Recruiting
Effects of Mirror Therapy and Motor Imagery on Upper Limb Motor Functions in Middle Cerebral Artery Stroke
Stroke
Not yet recruitingPhase 3
Cilostazol for Prevention of Recurrent Stroke Trial
Stroke Recurrence, Myocardial Infarction
Recruiting
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Brainstem Stroke, ALS
Not yet recruiting
Pilot Study to Determine the Optimal Protocol for Preoperative Transcutaneous Vagal Neurostimulation
Atrial Fibrillation (AF), Cerebral Vascular Accident (CVA)
RecruitingObservational study
Registry for CADASIL
Cerebral Autosomal Dominant Ateriopathy With Subcortical Infarcts and Leukoencephalopathy
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.
Bent Indredavik, Prof study director
National Taiwan Normal University
Torunn Askim, PhD principal investigator
National Taiwan Normal 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 Long term follow up by a coordinating physiotherapist in people with Cerebral Infarction and Cerebral Hemorrhage, run by Norwegian University of Science and Technology at 2 sites in Norway.
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 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2020. 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 Norway. 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?
Motor Assessment Scale (time frame: 18 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01467206, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2020.