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New treatment option for Stroke
Official title At Home Wearable Sensors and Smartphone for Stroke Survivors With Upper Limb Motor Challenges.
ClinicalTrials.gov ID: NCT06787729
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn if wearable sensor data visualization on smartphones can improve the use of the stroke-affected limb during everyday activities. Chronic stroke survivors (\>12 months from onset) ages 18-80 years old with residual upper extremity motor impairments may be eligible to participate.
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
- Stroke survivor (ischemic or hemorrhagic), \>12 months post stroke, at the time of consent
- Aged between 18 and 80
- Ability to extend ≥ 10° at the metacarpophalangeal joint and one of the interphalangeal joints of each finger, ≥ 10° extension or abduction of the...
- Demonstrating more affected arm nonuse, defined as a MAL-AoU score of \</= 4.5.
- Actively uses at least one smartphone app.
You likely can't join if
- Cognitive impairments that may affect the ability to understand and follow instructions (score \< 24 in the Mini Mental State Examination)
- Difficulties comprehending numbers, dyslexia, severe aphasia, or other neurological conditions that prohibit the use of smartphones for safety...
- Undergoing other types of motor therapy during the study period.
- Previous participation in constraint-induced movement therapy.
- Currently participating in or has participated in the past 3 months in any experimental rehabilitation or drug studies.
- Use of botulinum toxin for motor disability ≤ 3 months before treatment.
See the full eligibility criteria
- Stroke survivor (ischemic or hemorrhagic), \>12 months post stroke, at the time of consent
- Aged between 18 and 80
- Ability to extend ≥ 10° at the metacarpophalangeal joint and one of the interphalangeal joints of each finger, ≥ 10° extension or abduction of the thumb, and ≥ 20° extension of the wrist from a fully flexed starting...
- Demonstrating more affected arm nonuse, defined as a MAL-AoU score of \</= 4.5.
- Actively uses at least one smartphone app.
- Strong beliefs towards being in control of their recovery, indicated by a score of ≤ 10 points on the Internal Recovery Locus of Control (I-RLOC) Scale.
- Participants must be able to read, write, and understand English at a level sufficient to comprehend study materials and provide informed consent.
- Cognitive impairments that may affect the ability to understand and follow instructions (score \< 24 in the Mini Mental State Examination)
- Difficulties comprehending numbers, dyslexia, severe aphasia, or other neurological conditions that prohibit the use of smartphones for safety reasons.
- Undergoing other types of motor therapy during the study period.
- Previous participation in constraint-induced movement therapy.
- Currently participating in or has participated in the past 3 months in any experimental rehabilitation or drug studies.
- Use of botulinum toxin for motor disability ≤ 3 months before treatment.
- Significant changes in pharmacological or treatment plans during the study period that may affect upper-limb use.
- Major medical problems that could interfere with participation.
- History of a disabling stroke (i.e., need more than minimum assistance to perform ADLs).
- Legally blind status.
- Uncontrolled seizures.
- Inability to don/doff sensors independently or with the assistance of a caregiver.
- Implantable medical devices that do not comply with the ISO 14117:2012 and/or ANSI/AAMI PC69 standards for electromagnetic compatibility. people will be asked to provide their medical device record card, and...
The study team makes the final eligibility decision.
Where it's taking place
- Charlestown, Massachusetts, United States
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 Charlestown, Massachusetts, United States. 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.