StrokeNCT02778087
Mirror Therapy After Stroke: A Dosing Study
A study testing Mirror Box Therapy in people with Stroke, run by Columbia University at 1 site in United States.
Trial summary
It has been suggested that augmenting repetitive task practice with the use of box (mirror) therapy (BT) can enhance the benefits of task practice and may provide stroke survivors an opportunity to engage in self-directed practice outside of normally scheduled therapy sessions. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Stroke
- What is being tested?
- Mirror Box Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 13 Feb 2018
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults status post ischemic or hemorrhagic stroke between the ages 18-85, receiving inpatient rehabilitation
- Using the impaired arm, ability to lift and release a wash cloth off a table with any means of prehension in either the sitting or standing positions
- A score > 21/30 on the Mini-Mental State Exam
- Ability to consent.
Who cannot join
- Serious visual or visual-perceptual deficits, neuropsychological impairments, or orthopedic conditions that would prevent participation in the BT protocol as determined by the treatment team
- Involvement in another study protocol related to motor function after stroke
- Anticipated length of stay less than two weeks
- More than six months post stroke
Trial locations and contacts
1 site in 1 country.
United States1 site
Helen Hayes Hospital (Stroke Unit)
West Haverstraw, New York, 10993
About this study
Official title: Self-directed Box (Mirror) Therapy After Stroke: A Dosing Study
It has been suggested that augmenting repetitive task practice with the use of box (mirror) therapy (BT) can enhance the benefits of task practice and may provide stroke survivors an opportunity to engage in self-directed practice outside of normally scheduled therapy sessions. However, the dosage of BT to be used in clinical practice is unclear. In order for practitioners to begin integrating BT into clinical practice situations more information is needed to determine what defines a therapeutic dose. The aim of this study is to differentiate between two dosages of self-directed BT added to treatment as usual for decreasing arm and hand motor impairments, improving activity level, and increasing self-directed participation after stroke. Forty-five subjects from the Stroke Rehabilitation Unit at Helen Hayes Hospital (HHH) will be randomly assigned into three groups: treatment as usual plus 30 minute dosage of self-directed BT 5x/week; treatment as usual plus 60 minute dosage of self-directed BT 5x/week; treatment as usual plus 30 minutes of self-directed sham BT 5x/week.
Read the detailed description
Approximately 795,000 people in the United States have a stroke each year, and stroke is considered a leading cause of long-term disability. Impairments in arm and hand function are common after stroke and limit engagement in daily life activities, which impacts the overall quality of life of stroke survivors. It has been found that incomplete upper limb recovery predicted health related quality of life in stroke survivors at one year post-stroke in four (self-care, usual activities, pain/discomfort, \& anxiety/depression) out of five domains measured on the EuroQol-5D questionnaire. Thus, evidence-based interventions that improve arm and hand function after stroke are needed. In fact, a recent study identified "treatments for upper extremity recovery" to be one of the top ten research priorities relating to life after stroke according to stroke survivors, caregivers, and health professionals. Evidence suggests task-oriented training interventions such as Repetitive Task Practice (RTP) are effective at improving upper extremity (UE) function and activity, and therapy participation in stroke survivors.
Recently, it has been suggested that augmenting RTP with the use of cognitive strategies, such as Mirror Box Therapy (BT), can enhance the benefits of task practice and may provide stroke survivors an opportunity to engage in self-directed practice outside of normally scheduled therapy sessions. During BT, a person engages in motor activities with the unimpaired limb while watching its mirror reflection superimposed over the (unseen) impaired limb; this process creates a visual illusion whereby activities performed by the unimpaired limb are attributed to the impaired limb. While generating this visual illusion is a common ingredient in published BT effectiveness trials, the actual treatment protocols differ considerably. One important protocol difference seen across published trials relates to the dosage of BT. For instance, the minutes of BT provided range from 10 minutes to 60 minutes per session; session frequencies range from 1 to 7 sessions per week, and the length of the intervention ranges from 3 to 6 weeks. Thus, the dosage of BT to be used in clinical practice is unclear. In order for practitioners to begin integrating BT into clinical practice more information is needed on the effective dosage, as this may vary according to multiple factors (e.g., stage of recovery, the survivor's current functional limitations, or environment in which services are rendered).
- Conditions
- Stroke
- Being tested
- Mirror Box Therapy, Sham Mirror Box Therapy
- Keywords
- motor recovery, mirror therapy, upper extremity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror Box TherapyBehavioural
The BT intervention will be delivered in 15 minute increments via a self-directed program. The subject will sit comfortably at a table or desk in front of a box, which will be positioned in the mid-sagittal plane. The subject will place his or her affected arm inside the box so that it is out of view. The subject will then place his or her unaffected arm on the table and will be instructed to focus their attention on the mirror reflection of the unaffected arm throughout the intervention. The 15 minute intervention will consist of the following movements/tasks: active range of motion (AROM), functional tasks with objects, and object manipulation.
Sham Mirror Box TherapyBehavioural
The BT intervention will be delivered in 15 minute increments via a self-directed program. The subject will sit comfortably at a table or desk in front of a box, which will be positioned in the mid-sagittal plane. The subject will place his or her affected arm inside the box so that it is out of view. The subject will then place his or her unaffected arm on the table and will be instructed to focus their attention on an opaque mirror throughout the intervention. The 15 minute intervention will consist of the following movements/tasks: AROM, functional tasks with objects, and object manipulation.
| Study group | Role | What they receive |
|---|---|---|
| TAU plus 30 minutes of BT. | Experimental | Intervention: Subjects randomized to the 30 minute intervention will perform the above 15 minute Mirror Box Therapy intervention independently two times per day in addition to their treatment as usual. Receives: Behavioral: Mirror Box Therapy |
| TAU plus 60 minute of BT. | Experimental | Intervention: Subjects randomized to the 60 minute intervention will perform the above 15 minute Mirror Box Therapy intervention independently four times per day in addition to their treatment as usual. Receives: Behavioral: Mirror Box Therapy |
| TAU plus 30 minutes of sham BT. | Sham comparator | Intervention: Subjects randomized to the control (sham) group will perform the above Sham Mirror Box Therapy intervention independently two times per day. The control group will be using a mirror box with an opaque surface as opposed to a reflective mirror. Receives: Behavioral: Sham Mirror Box Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on Action Research Arm Test:
This test examines hand and arm motor function. It consists of 19 movement tasks divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale, ranging from 3 (performs test normally) to 0 (can perform no part of test). Totaled scores range from 0-57 with higher scores indicating higher functioning. Normative data for stroke has been published for this tool (Beebe \& Lang, 2009; van der Lee et al., 2001). This tool has been found to be a valid measure (Platz et al., 2005; van der Lee et al., 2001). This test has excellent test-retest reliability (Platz et al., 2005), as well as inter-rater reliability (Nijland et al., 2010). Minimally clinically important difference (MCID) for this test has been established for both acute (Lang et al., 2008) and chronic stroke survivors (van der Lee et al., 2001).
Measured: pre and post intervention up to 12 months
Secondary outcomes (3)
Score on Stroke Impact Scale
This is a questionnaire including questions regarding whether the stroke has resulted in physical problems, problems with memory and thinking, changes in mood and emotions, problems with communication, daily living skills, mobility, and hand function. Normative data has been published for stroke survivors (Duncan et al., 2002). Several authors have established the validity of this tool (Doyle et al., 2007; Duncan et al., 2002; Huang et al., 2010; Kwon et al., 2006). This measure has adequate to excellent test-retest reliability depending on the domain (Duncan et al., 1999), as well as intra-rater reliability (Carod-Artal et al., 2009).
Measured: pre and post intervention up to 12 months
Score on Functional Independence Measure
This provides a measurement of a subject's disability based on the International Classification of Impairment, Disabilities and Handicaps, and it indicates how much assistance the individual will need to carry out common basic activities of daily living. It contains 18 items that are rated on a seven point ordinal scale from total assistance to complete independence, and totaled scores range from a low of 18 to a high of 126, with higher scores indicating higher functioning. Normative data has been published for stroke survivors (Inouye et al., 2001). The validity of this measure has established (Inouye et al., 2001; Denti et al., 2008; Hsueh et al., 2002). This test has been found to have excellent test-retest reliability (Pollak et al., 1996; Hobart et al., 2001).
Measured: pre and post intervention up to 12 months
Score on Fugl-Meyer Assessment of Motor Recovery after Stroke (arm/hand section)
This test examines a variety of reaching patterns, wrist and hand function, quality of movement, sensation, and reflexes. Items are scored on a 3-point ordinal scale from 0 (cannot perform) to 2 (performs fully). The domains assessed include: Motor function (UE maximum score = 66), Sensory function (UE maximum score = 12), and Joint pain (maximum score = 24). This tool is one of the most widely used quantitative measures of motor impairment after stroke (Gladstone et al., 2002). Multiple authors have documented the validity of this tool (Malouin et al., 1994; Mao et al., 2002; Shelton et al., 2001). It has excellent inter- and intra-rater reliability (Duncan, 1983). It has been found to be a strong predictor of motor function (Duncan, et al., 1992).
Measured: pre and post intervention up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startJan 2017
- Primary completion13 Feb 2018
- Study completion13 Feb 2018
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 StrokeStudies of the same condition, open and under way.
- More trials run by Columbia 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Helen Hayes Hospital
- Responsible party
- Principal investigator, Glen Gillen, Columbia University
- Investigators
- Glen Gillen, EdD, OTR, Principal investigator, Columbia UniversitySteven W. Lichtman, EdD, Study director, Helen Hayes Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778087
- Sponsor's protocol ID
- AAAQ2004
- Status last verified
- Feb 2018
- First submitted
- 17 May 2016
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Nilsen DM, Gillen G, Geller D, Hreha K, Osei E, Saleem GT. Effectiveness of interventions to improve occupational performance of people with motor impairments after stroke: an evidence-based review. Am J Occup Ther. 2015 Jan-Feb;69(1):6901180030p1-9. doi: 10.5014/ajot.2015.011965.
PubMed 25553742Nilsen DM, DiRusso T. Using mirror therapy in the home environment: a case report. Am J Occup Ther. 2014 May-Jun;68(3):e84-9. doi: 10.5014/ajot.2014.010389.
PubMed 24797202Thieme H, Mehrholz J, Pohl M, Behrens J, Dohle C. Mirror therapy for improving motor function after stroke. Stroke. 2013 Jan;44(1):e1-2. doi: 10.1161/strokeaha.112.673087.
PubMed 23390640Thieme H, Mehrholz J, Pohl M, Behrens J, Dohle C. Mirror therapy for improving motor function after stroke. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD008449. doi: 10.1002/14651858.CD008449.pub2.
PubMed 22419334Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. No abstract available.
PubMed 25520374
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-directed Box (Mirror) Therapy After Stroke: A Dosing Study
- ClinicalTrials.gov ID
- NCT02778087
- Acronym / sponsor ID
- AAAQ2004
- Conditions
- Stroke
- Keywords
- motor recovery, mirror therapy, upper extremity
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Helen Hayes Hospital
- Study start
- Jan 2017
- Primary completion
- 13 Feb 2018 (actual)
- Study completion
- 13 Feb 2018 (actual)
- First posted
- 19 May 2016 (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.
It has been suggested that augmenting repetitive task practice with the use of box (mirror) therapy (BT) can enhance the benefits of task practice and may provide stroke survivors an opportunity to engage in self-directed practice outside of normally scheduled therapy sessions. However, the dosage of BT to be used in clinical practice is unclear. In order for practitioners to begin integrating BT into clinical practice situations more information is needed to determine what defines a therapeutic dose. The aim of this study is to differentiate between two dosages of self-directed BT added to treatment as usual for decreasing arm and hand motor impairments, improving activity level, and increasing self-directed participation after stroke. Forty-five subjects from the Stroke Rehabilitation Unit at Helen Hayes Hospital (HHH) will be randomly assigned into three groups: treatment as usual plus 30 minute dosage of self-directed BT 5x/week; treatment as usual plus 60 minute dosage of self-directed BT 5x/week; treatment as usual plus 30 minutes of self-directed sham BT 5x/week.
Detailed description
Approximately 795,000 people in the United States have a stroke each year, and stroke is considered a leading cause of long-term disability. Impairments in arm and hand function are common after stroke and limit engagement in daily life activities, which impacts the overall quality of life of stroke survivors. It has been found that incomplete upper limb recovery predicted health related quality of life in stroke survivors at one year post-stroke in four (self-care, usual activities, pain/discomfort, \& anxiety/depression) out of five domains measured on the EuroQol-5D questionnaire. Thus, evidence-based interventions that improve arm and hand function after stroke are needed. In fact, a recent study identified "treatments for upper extremity recovery" to be one of the top ten research priorities relating to life after stroke according to stroke survivors, caregivers, and health professionals. Evidence suggests task-oriented training interventions such as Repetitive Task Practice (RTP) are effective at improving upper extremity (UE) function and activity, and therapy participation in stroke survivors.
Recently, it has been suggested that augmenting RTP with the use of cognitive strategies, such as Mirror Box Therapy (BT), can enhance the benefits of task practice and may provide stroke survivors an opportunity to engage in self-directed practice outside of normally scheduled therapy sessions. During BT, a person engages in motor activities with the unimpaired limb while watching its mirror reflection superimposed over the (unseen) impaired limb; this process creates a visual illusion whereby activities performed by the unimpaired limb are attributed to the impaired limb. While generating this visual illusion is a common ingredient in published BT effectiveness trials, the actual treatment protocols differ considerably. One important protocol difference seen across published trials relates to the dosage of BT. For instance, the minutes of BT provided range from 10 minutes to 60 minutes per session; session frequencies range from 1 to 7 sessions per week, and the length of the intervention ranges from 3 to 6 weeks. Thus, the dosage of BT to be used in clinical practice is unclear. In order for practitioners to begin integrating BT into clinical practice more information is needed on the effective dosage, as this may vary according to multiple factors (e.g., stage of recovery, the survivor's current functional limitations, or environment in which services are rendered).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TAU plus 30 minutes of BT. | Experimental | Behavioral: Mirror Box TherapyIntervention: Subjects randomized to the 30 minute intervention will perform the above 15 minute Mirror Box Therapy intervention independently two times per day in addition to their treatment as usual. |
| TAU plus 60 minute of BT. | Experimental | Behavioral: Mirror Box TherapyIntervention: Subjects randomized to the 60 minute intervention will perform the above 15 minute Mirror Box Therapy intervention independently four times per day in addition to their treatment as usual. |
| TAU plus 30 minutes of sham BT. | Sham comparator | Behavioral: Sham Mirror Box TherapyIntervention: Subjects randomized to the control (sham) group will perform the above Sham Mirror Box Therapy intervention independently two times per day. The control group will be using a mirror box with an opaque surface as opposed to a reflective mirror. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults status post ischemic or hemorrhagic stroke between the ages 18-85, receiving inpatient rehabilitation
- Using the impaired arm, ability to lift and release a wash cloth off a table with any means of prehension in either the sitting or standing positions
- A score > 21/30 on the Mini-Mental State Exam
- Ability to consent.
Key exclusion criteria (4 listed)
- Serious visual or visual-perceptual deficits, neuropsychological impairments, or orthopedic conditions that would prevent participation in the BT protocol as determined by the treatment team
- Involvement in another study protocol related to motor function after stroke
- Anticipated length of stay less than two weeks
- More than six months post stroke
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 |
|---|---|---|
| Mirror Box TherapyThe BT intervention will be delivered in 15 minute increments via a self-directed program. The subject will sit comfortably at a table or desk in front of a box, which will be positioned in the mid-sagittal plane. The subject will place his or her affected arm inside the box so that it is out of view. The subject will then place his or her unaffected arm on the table and will be instructed to focus their attention on the mirror reflection of the unaffected arm throughout the intervention. The 15 minute intervention will consist of the following movements/tasks: active range of motion (AROM), functional tasks with objects, and object manipulation. | Behavioural | TAU plus 30 minutes of BT., TAU plus 60 minute of BT. |
| Sham Mirror Box TherapyThe BT intervention will be delivered in 15 minute increments via a self-directed program. The subject will sit comfortably at a table or desk in front of a box, which will be positioned in the mid-sagittal plane. The subject will place his or her affected arm inside the box so that it is out of view. The subject will then place his or her unaffected arm on the table and will be instructed to focus their attention on an opaque mirror throughout the intervention. The 15 minute intervention will consist of the following movements/tasks: AROM, functional tasks with objects, and object manipulation. | Behavioural | TAU plus 30 minutes of sham BT. |
Primary outcome
Score on Action Research Arm Test:
Time frame: pre and post intervention up to 12 months
This test examines hand and arm motor function. It consists of 19 movement tasks divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale, ranging from 3 (performs test normally) to 0 (can perform no part of test). Totaled scores range from 0-57 with higher scores indicating higher functioning. Normative data for stroke has been published for this tool (Beebe \& Lang, 2009; van der Lee et al., 2001). This tool has been found to be a valid measure (Platz et al., 2005; van der Lee et al., 2001). This test has excellent test-retest reliability (Platz et al., 2005), as well as inter-rater reliability (Nijland et al., 2010). Minimally clinically important difference (MCID) for this test has been established for both acute (Lang et al., 2008) and chronic stroke survivors (van der Lee et al., 2001).
3 secondary outcomes
Score on Stroke Impact Scale
Time frame: pre and post intervention up to 12 months
Score on Functional Independence Measure
Time frame: pre and post intervention up to 12 months
Score on Fugl-Meyer Assessment of Motor Recovery after Stroke (arm/hand section)
Time frame: pre and post intervention up to 12 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Background: PubMed 25553742Nilsen DM, Gillen G, Geller D, Hreha K, Osei E, Saleem GT. Effectiveness of interventions to improve occupational performance of people with motor impairments after stroke: an evidence-based review. Am J Occup Ther. 2015 Jan-Feb;69(1):6901180030p1-9. doi: 10.5014/ajot.2015.011965.
- Background: PubMed 24797202Nilsen DM, DiRusso T. Using mirror therapy in the home environment: a case report. Am J Occup Ther. 2014 May-Jun;68(3):e84-9. doi: 10.5014/ajot.2014.010389.
- Background: PubMed 23390640Thieme H, Mehrholz J, Pohl M, Behrens J, Dohle C. Mirror therapy for improving motor function after stroke. Stroke. 2013 Jan;44(1):e1-2. doi: 10.1161/strokeaha.112.673087.
- Background: PubMed 22419334Thieme H, Mehrholz J, Pohl M, Behrens J, Dohle C. Mirror therapy for improving motor function after stroke. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD008449. doi: 10.1002/14651858.CD008449.pub2.
- Background: PubMed 25520374Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. No abstract available.
- Individual participant dataSharing planned: No
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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.
Glen Gillen, EdD, OTR principal investigator
Columbia University
Steven W. Lichtman, EdD study director
Helen Hayes 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 Mirror Box Therapy in people with Stroke, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 was stopped early. Results are not available in the source record.
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?
Score on Action Research Arm Test: (time frame: pre and post intervention up to 12 months). 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 NCT02778087, 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 14 Feb 2018.