StrokeTR-2NCT06682429
Telerehabilitation In The Home After Stroke
A study testing Telerehabilitation in people with Stroke, run by University of California, Los Angeles at 27 sites in United States.
Trial summary
The purpose of this research study is to evaluate whether telerehabilitation targeting arm movement, when added to usual care, improves arm function and reduces global disability after stroke, compared to usual care alone. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Telerehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 27 sitesUnited States
- Study dates
- 22 Aug 2025to Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-85 years at the time of randomization
- The index stroke was radiologically verified, due to ischemia or intracerebral hemorrhage (ICH), and had time of onset 90-270 days prior to randomization
- The stroke caused upper extremity deficits as defined by Action Research Arm Test score 14-44 (out of 57) at Baseline Visit 1
- Box \& Block Test score with affected arm is ≥1 block in 60 seconds at Baseline Visit 1
- Able to successfully perform all 3 rehabilitation exercise test examples (simple commands) at Baseline Visit 1
- Informed consent and behavioral contract signed by the subject (i.e., no surrogate consent)
Who cannot join
- A major, active, coexistent neurological, psychiatric, or medical disease that reduces the likelihood that a subject will be able to comply with all study procedures
- Unable or unwilling to perform study procedures/therapy, or expectation of noncompliance with study procedures/therapy, or expectation that subject cannot participate in all study visits
- A diagnosis (apart from the index stroke) that substantially affects paretic arm function
- Severe depression, defined as Geriatric Depression Scale Score >10/15 at Baseline Visit 1
- Significant cognitive impairment, defined as Montreal Cognitive Assessment score <22 [a lower score is permitted if due to aphasia and allowed by the site PI]
- Deficits in communication that interfere with reasonable study participation
Show all 18Show fewer
- Severe UE spasticity, defined as presence of contracture or modified Ashworth Scale score=4 in either biceps or pectoralis
- Modified Rankin Scale score was >2 prior to the index stroke
- A new symptomatic stroke has occurred since the index stroke, or a separate stroke occurred within 30 days prior to the index stroke
- Lacking visual acuity, with or without corrective lens, of 20/50 or better in at least one eye
- Life expectancy < 9 months
- Pregnant; women of child-bearing potential must have a negative pregnancy test
- Botulinum toxin to the paretic arm: received in the prior 3 months OR expected by the 8-Month Visit
- Concurrent enrollment in another therapy-based investigational study where the duration of the investigational therapy's activity is likely to occur during the subject's participation in the study
- Subject lacks sufficient English or Spanish to comply with study procedures and TR instructions
- Expectation that subject will not have a single domicile address during the 6 weeks of therapy that is within 1.5-hr drive of the central study site [this can be waived at the discretion of the site PI]
- Contraindication to MRI
- On isolation precautions, e.g., due to active COVID-19
Trial locations and contacts
27 sites in 1 country. Contact the study team or a site near you to ask about taking part.
27 sites in 1 country
United States27 sites, 27 recruiting
- Recruiting
University of Michigan University Hospital
Ann Arbor, Michigan, 48108
Danny Shin, (734)615-3904, ddshin@umich.edu
Chandramouli Krishnan, PhD
- Recruiting
Emory Rehabilitation Hospital
Atlanta, Georgia, 30322
Susan Murphy, (404)712-1928, smurph7@emory.edu
Michael Borich, PhD, PT
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Julie DiCarlo, (617)726-1311, jdicarlo2@mgh.harvard.edu
David Lin, MD
- Recruiting
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27514
Jessica Cassidy, (919)843-5774, jcassidy@med.unc.edu
Jessica Cassidy, PhD, PT
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Michelle Shanahan, 843-792-7751, shanaha@musc.edu
Parneet Grewal, MD
- Recruiting
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, 02129
Qing Mei Wang, MD, (617)952-5299, wang.qingmei@mgh.harvard.edu
Qing Mei Wang, MD
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45219
Colin Drury, (513)558-7656, drurycd@ucmail.uc.edu
Oluwole Awosika, MD
- Not yet recruiting
MetroHealth Old Brooklyn Health Center
Cleveland, Ohio, 44109
Krissy Hansen, PT, (216)957-3584, khansen1@metrohealth.org
David Cunningham, PhD
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Heidi Poppendeck, (216)704-3675, poppenh@ccf.org
Christina Xia, MD
- Recruiting
Rancho Los Amigos Research Institute
Downey, California, 90242
Jason Garcia, (562)385-6939, jasong@ranchoresearch.org
Charles Liu, MD
- Recruiting
Duke University Hospital
Durham, North Carolina, 27710
Megan Gonzalez, (919)668-7597, megan.gonzalez@duke.edu
Wayne Feng, MD
- Recruiting
Jefferson Moss Rehabilitation Research Institute
Elkins Park, Pennsylvania, 19027
Paria Arfa-Fatollahkhani, (215)663-6400, tr2trial@mednet.ucla.edu
Dylan Edwards, PhD
- Not yet recruiting
The Institute for Rehabilitation and Research (TIRR) Memorial Hermann
Houston, Texas, 77030
Alyssa Miller, MSc, (713)797-7132, alyssa.miller@uth.tmc.edu
Gerard Francisco, MD
- Recruiting
UT Houston/Memorial Hermann Hospital TMC
Houston, Texas, 77030
Ruth Yanes Bengoa, (713)500-7934, Ruth.S.YanesBengoa@uth.tmc.edu
Sean Savitz, MD
- Recruiting
University of California, Irvine
Irvine, California, 92868
Lucy Dodakian, OT, (949)824-8748, ldodak@hs.uci.edu
An Do, MD
- Recruiting
Brooks Rehabilitation Hospital
Jacksonville, Florida, 32216
Taisiya Matev, (904)345-8973, taisiya.matev@brooksrehab.org
Lauren Shapiro, MD
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Sasha Moores, (913)588-2697, smoores@kumc.edu
Sandra Billinger, PhD, PT
- Recruiting
Keck Medical Center of USC
Los Angeles, California, 90033
Stuti Chakraborty, (626)642-8213, stuticha@usc.edu
Sook-Lei Liew, PhD
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90095
Ryan McCarville, (424)522-7874, tr2trial@mednet.ucla.edu
Steven C Cramer, MD, FAAN, FAHA
- Not yet recruiting
Jackson Memorial Hospital Christine E. Lynn Rehabilitation Center
Miami, Florida, 33136
Dinorah Rodriguez, RN, (305)243-2797, drodriguez5@med.miami.edu
Sony Isaac, MD
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Karolina Roszkowski, 929-637-5818, karolina.roszkowski@mountsinai.org
David Putrino, PhD
- Recruiting
NYP Columbia University Medical Center
New York, New York, 10032
Michael Spinner, (212)305-9416, ms6431@cumc.columbia.edu
Joel Stein, MD
- Recruiting
Casa Colina Hospital and Centers for Healthcare
Pomona, California, 91767
Jeanette Gumarang, (909)596-7733, jgumarang@casacolina.org
Emily Rosario, PhD
- Recruiting
University of Utah Health
Salt Lake City, Utah, 84132
Amit Sethi, MD, (801)585-9292, amit.sethi@utah.edu
Amit Sethi, MD
- Recruiting
Hillcrest Medical Center at UC San Diego Health
San Diego, California, 92103
Theresa McQuaid, (619)543-4666, tmcquaid@health.ucsd.edu
Kunal Agrawal, MD
- Recruiting
Baystate Medical Center
Springfield, Massachusetts, 01199
Abraham Madjidov, (208)571-0434, abraham.madjidov@baystatehealth.org
Gottfried Schlaug, MD
- Recruiting
Medstar Health Research Institute
Washington D.C., District of Columbia, 20010
Gabrielle Edwards, (202)221-9998, gabrielle.edwards@medstar.net
Matthew Edwardson, MD
About this study
Official title: Telerehabilitation In The Home After Stroke: A Randomized, Controlled, Assessor-Blind Clinical Trial
The purpose of this research study is to evaluate whether telerehabilitation targeting arm movement, when added to usual care, improves arm function and reduces global disability after stroke, compared to usual care alone.
Patients with arm weakness due to stroke that happened in the past 90-270 days will be randomized into one of two groups: [1] TR and usual care; [2] usual care only (no TR), but people in the usual care group will be offered TR once the study is done. TR consists of 70 minutes/day of activities targeting arm function, 6 days a week for 6 weeks.
Read the detailed description
This is a randomized, assessor-blinded study that involves the use of telerehabilitation to deliver additional therapy for persons with stroke. Patients with arm weakness due to stroke that happened in the past 90-270 days will be randomized into one of two groups: [1] TR and usual care; [2] usual care only (no TR), but people in the usual care group will be offered TR once the study is done. TR consists of 70 minutes/day of activities targeting arm function, 6 days a week 6-8 weeks. The hypothesis of this study is patients receiving TR in addition to their usual care will have significantly greater recovery of arm function compared to patients receiving usual care alone.
Study participation will last approximately 8 months and includes 4 in-person visits. At these visits, patients will undergo a variety of assessments including tests of arm function and a single MRI scan of the brain. Patients undergoing TR will receive arm motor training, which consists of 36 sessions of assigned exercises, games, and stroke education; these total 70 minutes in length and occur 6 days a week for 6 weeks; TR subjects will also continue usual care. Patients in the usual care group only will not engage in TR but will instead continue all of the therapies recommended by their medical team. At the end of the study, participants in the usual care group will be offered TR.
- Conditions
- Stroke
- Being tested
- Telerehabilitation
- Keywords
- stroke, rehabilitation, telehealth
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationDevice
The telerehabilitation system will deliver rehabilitation treatment sessions via a secured internet-connected computer. TR sessions will be a combination of games, exercises, stroke education, assessments, in addition to videoconferencing with therapists to discuss progress, issues, goals, and changes to the treatment plan.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Participants in the usual care group will receive no TR, but will continue with the recommendations made by their care team. All participants in this group will be offered TR at the end of the study. |
| Telerehabilitation + Usual Care | Experimental | Patients will receive 36 telerehabilitation sessions targeting arm motor function in addition to their usual care. TR consists of 70 minutes/day of activities targeting arm function, 6 days/week for 6 weeks. Half of these sessions are supervised by a licensed therapist, and the other half are done independently. Receives: Device: Telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Action Research Arm Test (ARAT) Score from Baseline to 2 Months
The ARAT scale measures arm function using a scale that runs from 0 to 57 points, with higher numbers reflecting better arm function.
Measured: 2 months
Secondary outcomes (1)
Change in modified Rankin Scale (mRS) Score from Baseline to 2 Months
The mRS scale measures global function using a scale that runs from 0 to 6 points, with lower numbers reflecting better global function.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start22 Aug 2025
- Primary completionJun 2029 (estimated)
- Study completionJun 2030 (estimated)
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.
- More trials run by University of California, Los AngelesThe 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
- Model description
- Patients are randomized to TR + usual care or usual care alone
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Moss Rehabilitation Research Institute, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Steven C. Cramer, MD, FAAN, FAHA, FASNR, University of California, Los Angeles
- Investigators
- Steven Cramer, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682429
- Sponsor's protocol ID
- Q221354
- Acronym
- TR-2
- Status last verified
- Sep 2026
- First submitted
- 7 Nov 2024
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Non-PHI data will be shared with appropriate parties after the study is completed and published.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerehabilitation In The Home After Stroke: A Randomized, Controlled, Assessor-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT06682429
- Acronym / sponsor ID
- TR-2 / Q221354
- Conditions
- Stroke
- Keywords
- stroke, rehabilitation, telehealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Moss Rehabilitation Research Institute, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 22 Aug 2025 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 12 Nov 2024 (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 purpose of this research study is to evaluate whether telerehabilitation targeting arm movement, when added to usual care, improves arm function and reduces global disability after stroke, compared to usual care alone.
Patients with arm weakness due to stroke that happened in the past 90-270 days will be randomized into one of two groups: [1] TR and usual care; [2] usual care only (no TR), but people in the usual care group will be offered TR once the study is done. TR consists of 70 minutes/day of activities targeting arm function, 6 days a week for 6 weeks.
Detailed description
This is a randomized, assessor-blinded study that involves the use of telerehabilitation to deliver additional therapy for persons with stroke. Patients with arm weakness due to stroke that happened in the past 90-270 days will be randomized into one of two groups: [1] TR and usual care; [2] usual care only (no TR), but people in the usual care group will be offered TR once the study is done. TR consists of 70 minutes/day of activities targeting arm function, 6 days a week 6-8 weeks. The hypothesis of this study is patients receiving TR in addition to their usual care will have significantly greater recovery of arm function compared to patients receiving usual care alone.
Study participation will last approximately 8 months and includes 4 in-person visits. At these visits, patients will undergo a variety of assessments including tests of arm function and a single MRI scan of the brain. Patients undergoing TR will receive arm motor training, which consists of 36 sessions of assigned exercises, games, and stroke education; these total 70 minutes in length and occur 6 days a week for 6 weeks; TR subjects will also continue usual care. Patients in the usual care group only will not engage in TR but will instead continue all of the therapies recommended by their medical team. At the end of the study, participants in the usual care group will be offered TR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients are randomized to TR + usual care or usual care alone
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Participants in the usual care group will receive no TR, but will continue with the recommendations made by their care team. All participants in this group will be offered TR at the end of the study. |
| Telerehabilitation + Usual Care | Experimental | Device: TelerehabilitationPatients will receive 36 telerehabilitation sessions targeting arm motor function in addition to their usual care. TR consists of 70 minutes/day of activities targeting arm function, 6 days/week for 6 weeks. Half of these sessions are supervised by a licensed therapist, and the other half are done independently. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-85 years at the time of randomization
- The index stroke was radiologically verified, due to ischemia or intracerebral hemorrhage (ICH), and had time of onset 90-270 days prior to randomization
- The stroke caused upper extremity deficits as defined by Action Research Arm Test score 14-44 (out of 57) at Baseline Visit 1
- Box \& Block Test score with affected arm is ≥1 block in 60 seconds at Baseline Visit 1
- Able to successfully perform all 3 rehabilitation exercise test examples (simple commands) at Baseline Visit 1
Key exclusion criteria (18 listed)
- A major, active, coexistent neurological, psychiatric, or medical disease that reduces the likelihood that a subject will be able to comply with all study procedures
- Unable or unwilling to perform study procedures/therapy, or expectation of noncompliance with study procedures/therapy, or expectation that subject cannot participate in all study visits
- A diagnosis (apart from the index stroke) that substantially affects paretic arm function
- Severe depression, defined as Geriatric Depression Scale Score >10/15 at Baseline Visit 1
- Significant cognitive impairment, defined as Montreal Cognitive Assessment score <22 [a lower score is permitted if due to aphasia and allowed by the site PI]
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 |
|---|---|---|
| TelerehabilitationThe telerehabilitation system will deliver rehabilitation treatment sessions via a secured internet-connected computer. TR sessions will be a combination of games, exercises, stroke education, assessments, in addition to videoconferencing with therapists to discuss progress, issues, goals, and changes to the treatment plan. | Device | Telerehabilitation + Usual Care |
Primary outcome
Change in Action Research Arm Test (ARAT) Score from Baseline to 2 Months
Time frame: 2 months
The ARAT scale measures arm function using a scale that runs from 0 to 57 points, with higher numbers reflecting better arm function.
1 secondary outcome
Change in modified Rankin Scale (mRS) Score from Baseline to 2 Months
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes. Non-PHI data will be shared with appropriate parties after the study is completed and published.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Steven Cramer, MD principal investigator
University of California, Los Angeles
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation in people with Stroke, run by University of California, Los Angeles at 27 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 18 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steven Cramer, MD ((424)522-7874, tr2trial@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Action Research Arm Test (ARAT) Score from Baseline to 2 Months (time frame: 2 months). 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 5 Nov 2026.