StrokePhase 2VA ROBOTICSNCT00372411
Robotic Assisted Upper-Limb Neurorehabilitation in Stroke Patients
A Phase 2 study testing Robot-Assisted Therapy - MIT-MANUS System and Intensive Comparison Therapy in people with Stroke, run by US Department of Veterans Affairs at 5 sites in United States.
Trial summary
This study will compare robotic training with usual care and intensive comparison therapy to attempt to improve upper extremity function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Robot-Assisted Therapy - MIT-MANUS System and Intensive Comparison Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 5 sitesUnited States
- Study dates
- Dec 2005to Aug 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A single new focal unilateral stroke with diagnosis verified by brain imaging (MRI) or CT scan that has occurred at least 6 months prior to enrollment.
- Age 18 years of age and older.
- Upper extremity Fugl-Meyer score >=7 or <=38 (max 66). (These thresholds include neither hemiplegic nor fully recovered motor function in 14 muscles of the shoulder, elbow, and wrist.)
- Cognitive function sufficient to understand the experiments and follow instructions (Mini-Mental Status Score of 22 and higher or interview for aphasic subjects).
- Willingness to avoid any new alternative arm rehabilitative approaches for the duration of the study.
- Written informed consent to participate in the study.
Who cannot join
- A fixed contracture in the affected limb that prevents movement along the entire dynamic range required by either robot-assisted or intensive comparison therapy.
- Joint pain that occurs within the range of motion required by the intervention protocols (intensive comparison therapy and robot-assisted therapy).
- Enrolled in or planning to enroll in another interventional research trial that involves the upper limbs using procedures proposed to enhance or limit the function of the upper extremity (such as adjuvant rehabilitation or Botox injections) during the 36 weeks of participation.
- Prior experience with robot-assisted therapy or intensive comparison therapy for the upper limb as described in this specific study.
- A complicating medical condition that would prevent completion of the trial.
- Unable to complete the nine-month study, e.g., extended planned vacation.
- Any other known pre-existing bone diseases that might increase the risk of bone fracture or other injury from intensive comparison therapy or robot-assisted therapy.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, 21201
North Florida/South Georgia Veterans Health System
Gainesville, Florida, 32608
Providence VA Medical Center
Providence, Rhode Island, 02908-4799
VA Puget Sound Health Care System, Seattle
Seattle, Washington, 98108
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, 06516
About this study
Official title: CSP #558 - Robotic Assisted Upper-Limb Neurorehabilitation in Stroke Patients
This study will compare robotic training with usual care and intensive comparison therapy to attempt to improve upper extremity function.
Read the detailed description
Primary Hypothesis: The primary hypothesis is that robotic training compared with usual care and intensive comparison therapy will lead to improved upper extremity function. Eligible patients will be randomized to one of three treatment arms: 1) usual care, 2) intensive comparison therapy, or 3) robotic training. Participants assigned to intensive comparison therapy or robot-assisted training will receive treatment for 12 weeks consisting of three one-hour sessions a week and then usual care for the remainder of follow-up. Those assigned to usual care will receive the usual stroke care as delivered at each participating medical center for 36 weeks and then will be offered, as compassionate care, their choice of either robot-assisted or intensive comparison therapy.
Secondary Hypothesis: The secondary hypotheses are that compared with usual care and intensive comparison therapy, robotic treatment will lead to improved quality of life and task performance involving proximal and distal control of the paretic arm. If the robotic arm is effective, two other secondary objects are to evaluate its early (less than 12 week) and late (36 week) effects on the primary and secondary outcomes.
Primary Outcome: The primary study outcome is the change in the Fugl-Meyer score of neurological impairment at 12 weeks relative to baseline.
Secondary Outcome: Secondary outcomes include the Stroke Impact Scale and Wolf Motor Function Test. A cost-effectiveness analysis is planned but only will be conducted if robotic training is more effective than usual care.
Study Abstract: CSP #558 will be a randomized, multi-center, outpatient phase II trial to assess the safety and efficacy of robot-assisted therapy for neurorehabilitation in stroke patients with moderate to severe upper extremity impairment.
The target sample is 158 patients: 26 usual care, 66 intensive comparison therapy and 66 robot training. This sample size will provide 90% power to detect a 5-point mean difference in the Fugl-Meyer scale between robot training and usual care and 3-point mean difference between robot training and intensive comparison therapy. There will be one interim analysis of the primary endpoint at 12 months for the purpose of sample size re-estimation using an adaptive design. The planned study duration is 33 months with 24 months of intake and nine months of follow-up.
IMPACT STATEMENT
If robotic training proves to be beneficial it will not only provide a functionally-oriented and neurophysiologically appropriate therapy, but also will make more widely available high-quality, evidence-based rehabilitative care at a time when there is a shortage of experienced therapists and a progressively growing rehabilitative need for veterans and all Americans.
- Conditions
- Stroke
- Being tested
- Robot-Assisted Therapy - MIT-MANUS System, Intensive Comparison Therapy, Usual Care
- Keywords
- Stroke, Rehabilitation, Single-blind, Clinical Trial, Randomized controlled trial, Upper extremity, Robotics
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-Assisted Therapy - MIT-MANUS SystemDevice
The MIT-MANUS robot consists of four modules to train the entire upper limb: module A: shoulder-elbow; module B: anti-gravity; module C: wrist, and module D: hand-unit. Training will be given for 12 weeks and is divided into 4 consecutive blocks, with 9 training sessions per block.
Intensive Comparison TherapyOther
Also called ICT
The intensive comparison therapy protocol being used in CSP#558 was developed and field-tested at the Burke Rehabilitation Hospital. It exposes the patient to the identical number of treatments, time, and intensity that robot treated patients will receive (12 weeks, 3 times per week). Therapy sessions can be conducted on back-to-back days if needed and on more than 3 days a week (with approval from the Study Chairman) over a treatment period of up to 14 weeks in order to complete the 36 treatment sessions. During each 1-hour session, subjects participate in therapy in four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques (NDT)/Bobath arm training (Bobath, 1979).
Usual CareOther
The usual chronic stroke care as delivered at each participating medical center
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Robot-Assisted Therapy - MIT-MANUS System Receives: Device: Robot-Assisted Therapy - MIT-MANUS System |
| Arm 2 | Active comparator | Intensive Comparison Therapy Receives: Other: Intensive Comparison Therapy |
| Arm 3 | Other | Usual Care Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment for Motor Recovery (FM) Scale
Fugl-Meyer (FM) is a standard instrument for the quantitative clinical assessment of motor impairment and function. In this study the upper extremity subsection of the FM was used. The FM assesses several impairment dimensions by using a 3 point ordinal scale: 0 = cannot perform, 1 = can perform partially and 2 = can perform fully. These measures are summed to an overall score is Scoring for upper extremity FM ranges from 0 (worst, completely plegic) to 66 (best, normal). Higher scores indicate better functioning. Outcome measure is the change in the FM score at 6, 12, 24 and 36 weeks relative to baseline.
Measured: 6, 12, 24 and 36 weeks minus baseline
Secondary outcomes (4)
Stroke Impact Scale
The Stroke Impact Scale (SIS) is stroke specific, self-reported measure that evaluates function and quality of life in eight clinically relevant domains. The domains of hand function, activities of daily living, instrumental activities of daily living, mobility, and social participation were used; total score ranges from 0 to 100 with higher values indicating better functioning. Outcome is change at 6, 12, 24 and 36 weeks relative to baseline.
Measured: 6, 12, 24 and 36 weeks minus baseline
Wolf Motor Function Test
The Wolf Motor Function Test (WMFT) is a functionally-based test designed to provide an objective measure of both proximal (during tasks such as lifting the hand from table to box top) and distal control (grasping pencil, bringing soda can to mouth) of the paretic arm for patients after stroke or traumatic brain injury. The WMFT consists of 17 items, of which 15 measure time to perform functional tasks. The tasks are averaged to produce a score in seconds that ranges from 0 to 120 seconds, with higher scores indicating worse functioning. Outcome measure is the change in the Wolf score at 6, 12, 24 and 36 weeks relative to baseline.
Measured: 6, 12, 24 and 36 weeks minus baseline
Change in the Numeric Rating Scale (NRS) at 12 Weeks Relative to Baseline
The Numeric Rating Scale (NRS) for pain is a self report scale ranging from 0 (no Pain) to 10 (pain as bad as you can imagine).
Measured: 12 weeks minus baseline
Change in the Modified Ashworth Scale for Spasticity at 12 Weeks Relative to Baseline
The Modified Ashworth Scale for spasticity is a measurement of spasticity across 9 muscle groups. Each muscle group is scored on a 0 to 5 scale with higher scores indicating worse functioning. The total score is the average score from the 9 muscle groups and ranges from 0 to 5 with higher scores indicating worse functioning.
Measured: 12 weeks minus baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2006 (estimated)
- Study startDec 2005
- Primary completionJul 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- Burke Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Albert Lo, MD PhD, Study chair, Providence VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372411
- Sponsor's protocol ID
- 558
- Acronym
- VA ROBOTICS
- Status last verified
- Dec 2013
- First submitted
- 5 Sep 2006
- Last updated
- 13 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lo AC, Guarino P, Krebs HI, Volpe BT, Bever CT, Duncan PW, Ringer RJ, Wagner TH, Richards LG, Bravata DM, Haselkorn JK, Wittenberg GF, Federman DG, Corn BH, Maffucci AD, Peduzzi P. Multicenter randomized trial of robot-assisted rehabilitation for chronic stroke: methods and entry characteristics for VA ROBOTICS. Neurorehabil Neural Repair. 2009 Oct;23(8):775-83. doi: 10.1177/1545968309338195. Epub 2009 Jun 18.
PubMed 19541917Lo AC, Guarino PD, Richards LG, Haselkorn JK, Wittenberg GF, Federman DG, Ringer RJ, Wagner TH, Krebs HI, Volpe BT, Bever CT Jr, Bravata DM, Duncan PW, Corn BH, Maffucci AD, Nadeau SE, Conroy SS, Powell JM, Huang GD, Peduzzi P. Robot-assisted therapy for long-term upper-limb impairment after stroke. N Engl J Med. 2010 May 13;362(19):1772-83. doi: 10.1056/NEJMoa0911341. Epub 2010 Apr 16.
PubMed 20400552Wagner TH, Lo AC, Peduzzi P, Bravata DM, Huang GD, Krebs HI, Ringer RJ, Federman DG, Richards LG, Haselkorn JK, Wittenberg GF, Volpe BT, Bever CT, Duncan PW, Siroka A, Guarino PD. An economic analysis of robot-assisted therapy for long-term upper-limb impairment after stroke. Stroke. 2011 Sep;42(9):2630-2. doi: 10.1161/STROKEAHA.110.606442. Epub 2011 Jul 14.
PubMed 21757677Wittenberg GF, Richards LG, Jones-Lush LM, Roys SR, Gullapalli RP, Yang S, Guarino PD, Lo AC. Predictors and brain connectivity changes associated with arm motor function improvement from intensive practice in chronic stroke. F1000Res. 2016 Aug 31;5:2119. doi: 10.12688/f1000research.8603.2. eCollection 2016.
PubMed 28357039
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSP #558 - Robotic Assisted Upper-Limb Neurorehabilitation in Stroke Patients
- ClinicalTrials.gov ID
- NCT00372411
- Acronym / sponsor ID
- VA ROBOTICS / 558
- Conditions
- Stroke
- Keywords
- Stroke, Rehabilitation, Single-blind, Clinical Trial, Randomized controlled trial, Upper extremity, Robotics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- Burke Medical Research Institute
- Study start
- Dec 2005
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 7 Sep 2006 (estimated)
- Results
- Posted 13 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare robotic training with usual care and intensive comparison therapy to attempt to improve upper extremity function.
Detailed description
Primary Hypothesis: The primary hypothesis is that robotic training compared with usual care and intensive comparison therapy will lead to improved upper extremity function. Eligible patients will be randomized to one of three treatment arms: 1) usual care, 2) intensive comparison therapy, or 3) robotic training. Participants assigned to intensive comparison therapy or robot-assisted training will receive treatment for 12 weeks consisting of three one-hour sessions a week and then usual care for the remainder of follow-up. Those assigned to usual care will receive the usual stroke care as delivered at each participating medical center for 36 weeks and then will be offered, as compassionate care, their choice of either robot-assisted or intensive comparison therapy.
Secondary Hypothesis: The secondary hypotheses are that compared with usual care and intensive comparison therapy, robotic treatment will lead to improved quality of life and task performance involving proximal and distal control of the paretic arm. If the robotic arm is effective, two other secondary objects are to evaluate its early (less than 12 week) and late (36 week) effects on the primary and secondary outcomes.
Primary Outcome: The primary study outcome is the change in the Fugl-Meyer score of neurological impairment at 12 weeks relative to baseline.
Secondary Outcome: Secondary outcomes include the Stroke Impact Scale and Wolf Motor Function Test. A cost-effectiveness analysis is planned but only will be conducted if robotic training is more effective than usual care.
Study Abstract: CSP #558 will be a randomized, multi-center, outpatient phase II trial to assess the safety and efficacy of robot-assisted therapy for neurorehabilitation in stroke patients with moderate to severe upper extremity impairment.
The target sample is 158 patients: 26 usual care, 66 intensive comparison therapy and 66 robot training. This sample size will provide 90% power to detect a 5-point mean difference in the Fugl-Meyer scale between robot training and usual care and 3-point mean difference between robot training and intensive comparison therapy. There will be one interim analysis of the primary endpoint at 12 months for the purpose of sample size re-estimation using an adaptive design. The planned study duration is 33 months with 24 months of intake and nine months of follow-up.
IMPACT STATEMENT
If robotic training proves to be beneficial it will not only provide a functionally-oriented and neurophysiologically appropriate therapy, but also will make more widely available high-quality, evidence-based rehabilitative care at a time when there is a shortage of experienced therapists and a progressively growing rehabilitative need for veterans and all Americans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: Robot-Assisted Therapy - MIT-MANUS SystemRobot-Assisted Therapy - MIT-MANUS System |
| Arm 2 | Active comparator | Other: Intensive Comparison TherapyIntensive Comparison Therapy |
| Arm 3 | Other | Other: Usual CareUsual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A single new focal unilateral stroke with diagnosis verified by brain imaging (MRI) or CT scan that has occurred at least 6 months prior to enrollment.
- Age 18 years of age and older.
- Upper extremity Fugl-Meyer score >=7 or <=38 (max 66). (These thresholds include neither hemiplegic nor fully recovered motor function in 14 muscles of the shoulder, elbow, and wrist.)
- Cognitive function sufficient to understand the experiments and follow instructions (Mini-Mental Status Score of 22 and higher or interview for aphasic subjects).
- Willingness to avoid any new alternative arm rehabilitative approaches for the duration of the study.
Key exclusion criteria (7 listed)
- A fixed contracture in the affected limb that prevents movement along the entire dynamic range required by either robot-assisted or intensive comparison therapy.
- Joint pain that occurs within the range of motion required by the intervention protocols (intensive comparison therapy and robot-assisted therapy).
- Enrolled in or planning to enroll in another interventional research trial that involves the upper limbs using procedures proposed to enhance or limit the function of the upper extremity (such as adjuvant rehabilitation or Botox injections) during the 36 weeks of participation.
- Prior experience with robot-assisted therapy or intensive comparison therapy for the upper limb as described in this specific study.
- A complicating medical condition that would prevent completion of the trial.
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 |
|---|---|---|
| Robot-Assisted Therapy - MIT-MANUS SystemThe MIT-MANUS robot consists of four modules to train the entire upper limb: module A: shoulder-elbow; module B: anti-gravity; module C: wrist, and module D: hand-unit. Training will be given for 12 weeks and is divided into 4 consecutive blocks, with 9 training sessions per block. | Device | Arm 1 |
| Intensive Comparison TherapyAlso: ICTThe intensive comparison therapy protocol being used in CSP#558 was developed and field-tested at the Burke Rehabilitation Hospital. It exposes the patient to the identical number of treatments, time, and intensity that robot treated patients will receive (12 weeks, 3 times per week). Therapy sessions can be conducted on back-to-back days if needed and on more than 3 days a week (with approval from the Study Chairman) over a treatment period of up to 14 weeks in order to complete the 36 treatment sessions. During each 1-hour session, subjects participate in therapy in four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques (NDT)/Bobath arm training (Bobath, 1979). | Other | Arm 2 |
| Usual CareThe usual chronic stroke care as delivered at each participating medical center | Other | Arm 3 |
Primary outcome
Fugl-Meyer Assessment for Motor Recovery (FM) Scale
Time frame: 6, 12, 24 and 36 weeks minus baseline
Fugl-Meyer (FM) is a standard instrument for the quantitative clinical assessment of motor impairment and function. In this study the upper extremity subsection of the FM was used. The FM assesses several impairment dimensions by using a 3 point ordinal scale: 0 = cannot perform, 1 = can perform partially and 2 = can perform fully. These measures are summed to an overall score is Scoring for upper extremity FM ranges from 0 (worst, completely plegic) to 66 (best, normal). Higher scores indicate better functioning. Outcome measure is the change in the FM score at 6, 12, 24 and 36 weeks relative to baseline.
4 secondary outcomes
Stroke Impact Scale
Time frame: 6, 12, 24 and 36 weeks minus baseline
Wolf Motor Function Test
Time frame: 6, 12, 24 and 36 weeks minus baseline
Change in the Numeric Rating Scale (NRS) at 12 Weeks Relative to Baseline
Time frame: 12 weeks minus baseline
Change in the Modified Ashworth Scale for Spasticity at 12 Weeks Relative to Baseline
Time frame: 12 weeks minus baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19541917Lo AC, Guarino P, Krebs HI, Volpe BT, Bever CT, Duncan PW, Ringer RJ, Wagner TH, Richards LG, Bravata DM, Haselkorn JK, Wittenberg GF, Federman DG, Corn BH, Maffucci AD, Peduzzi P. Multicenter randomized trial of robot-assisted rehabilitation for chronic stroke: methods and entry characteristics for VA ROBOTICS. Neurorehabil Neural Repair. 2009 Oct;23(8):775-83. doi: 10.1177/1545968309338195. Epub 2009 Jun 18.
- Results publication: PubMed 20400552Lo AC, Guarino PD, Richards LG, Haselkorn JK, Wittenberg GF, Federman DG, Ringer RJ, Wagner TH, Krebs HI, Volpe BT, Bever CT Jr, Bravata DM, Duncan PW, Corn BH, Maffucci AD, Nadeau SE, Conroy SS, Powell JM, Huang GD, Peduzzi P. Robot-assisted therapy for long-term upper-limb impairment after stroke. N Engl J Med. 2010 May 13;362(19):1772-83. doi: 10.1056/NEJMoa0911341. Epub 2010 Apr 16.
- Results publication: PubMed 21757677Wagner TH, Lo AC, Peduzzi P, Bravata DM, Huang GD, Krebs HI, Ringer RJ, Federman DG, Richards LG, Haselkorn JK, Wittenberg GF, Volpe BT, Bever CT, Duncan PW, Siroka A, Guarino PD. An economic analysis of robot-assisted therapy for long-term upper-limb impairment after stroke. Stroke. 2011 Sep;42(9):2630-2. doi: 10.1161/STROKEAHA.110.606442. Epub 2011 Jul 14.
- Derived from this study: PubMed 28357039Wittenberg GF, Richards LG, Jones-Lush LM, Roys SR, Gullapalli RP, Yang S, Guarino PD, Lo AC. Predictors and brain connectivity changes associated with arm motor function improvement from intensive practice in chronic stroke. F1000Res. 2016 Aug 31;5:2119. doi: 10.12688/f1000research.8603.2. eCollection 2016.
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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.
Albert Lo, MD PhD study chair
Providence VA Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Robot-Assisted Therapy - MIT-MANUS System and Intensive Comparison Therapy in people with Stroke, run by US Department of Veterans Affairs at 5 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 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Fugl-Meyer Assessment for Motor Recovery (FM) Scale (time frame: 6, 12, 24 and 36 weeks minus baseline). 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 NCT00372411, which also lists 4 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 Jan 2014.