BridgeMD
New treatment option for Stroke
Official title Telerehabilitation In The Home After Stroke
ClinicalTrials.gov ID: NCT06682429
What this study is testing
- What it's testing
- 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 90-150 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age 18-80 years at the time of randomization
- The index stroke was radiologically verified, due to ischemia or intracerebral hemorrhage (ICH), and had time of onset 120±30 days prior to...
- The stroke caused upper extremity deficits as defined by Action Research Arm Test score 18-44 (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
You likely can't join if
- A major, active, coexistent neurological, psychiatric, or medical disease that reduces the likelihood that a subject will be able to comply with all...
- Unable or unwilling to perform study procedures/therapy, or expectation of noncompliance with study procedures/therapy, or expectation that subject...
- 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...
- Deficits in communication that interfere with reasonable study participation
See the full eligibility criteria
- Age 18-80 years at the time of randomization
- The index stroke was radiologically verified, due to ischemia or intracerebral hemorrhage (ICH), and had time of onset 120±30 days prior to randomization
- The stroke caused upper extremity deficits as defined by Action Research Arm Test score 18-44 (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)
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Downey, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Pomona, California, United States
- San Diego, California, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Kansas City, Kansas, United States
- Boston, Massachusetts, United States
- Charlestown, Massachusetts, United States
- Springfield, Massachusetts, United States
- Ann Arbor, Michigan, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Elkins Park, Pennsylvania, United States
+ 3 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Downey, California, United States; Irvine, California, United States; Los Angeles, California, United States; Pomona, California, United States; San Diego, California, United States; Washington D.C., District of Columbia, United States and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.