An interventional study of Smartwatch App for Movement Variability and Smartwatch App for Active Time in Chronic Stroke Patients, sponsored by University of California, Irvine. Recruiting at 1 site in United States. Open to participants aged 18 Years to 84 Years. Per ClinicalTrials.gov, last updated 2025-08-19.
Sponsored by University of California, Irvine · Not applicable, Interventional, and Treatment
The goal of this study is to determine the effectiveness of behavioral support and feedback from a wearable device that senses arm movement in improving upper extremity function in a pilot, randomized controlled trial with chronic stroke patients
In this randomized controlled trial, the investigators will evaluate two telerehabilitation strategies for increasing arm use at home: a smartwatch app and a psychological intervention. The psychological intervention aims to address ambivalence and enhance motivation, while the smartwatch provides feedback on arm movement variability. The investigators hypothesize that combining the psychological intervention with smartwatch feedback will lead to greater improvements in arm use and upper extremity recovery
University of California, Irvine is the lead sponsor of 466 studies on the registry; 96 are open to participants now.
Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The movement variability group will have a smartwatch app that records movement variability. Their movement goal will be centered on increasing their total movement variability as measured by the watch.
Other: Smartwatch App for Movement Variability · Behavioral: Motivational Interviewing (Within Subjects)
This group will only receive active-time feedback (the number of minutes and hours moving the upper extremity). Their goal will focus on increasing their total movement time.
Other: Smartwatch App for Active Time · Behavioral: Motivational Interviewing (Within Subjects)
This app measures movement variability in the upper extremity as described in our previous study (doi:10.3390/s24165266).
The other software we are using measures total active time of the upper extremity.
Motivational Interviewing is an established therapeutic technique designed to increase patient adherence to therapy by addressing ambivalence. The motivational Interviewing sessions will include a variety of techniques such as: Open ended questions, Active Listening, Affirmation, Summarization, Questions focused on change talk, and Providing Information.
Variability Measurement
The amount of variability for the impaired upper extremity will be quantified by the variety of movements performed.
Time frame: From enrollment to the end of treatment and follow up measurement (9 weeks)
Active Time
This outcome measures the active time of the impaired upper extremity in minutes and hours.
Time frame: From enrollment to the end of treatment and follow up measurement (9 weeks)
Fugl-Meyer Arm Motor Assessment
The Fugl-Meyer Arm Motor Assessment measures motor impairment, movement coordination, reflexes, and functional ability of the upper limb in stroke patients, providing a quantitative evaluation of motor recovery based on a standardized scoring system.
Time frame: Initial Visit, First follow up, Second follow up
Box and Blocks Test
The Box and Blocks Test (BBT) measures manual dexterity, unilateral gross motor function, and upper limb coordination in stroke patients by assessing the number of blocks transferred within a set time, providing an objective indicator of motor recovery and functional hand use.
Time frame: Initial Visit, First follow up, second follow up
Nine Hole Peg Test
The 9-Hole Peg Test (9HPT) measures fine motor coordination, dexterity, and finger-hand function by assessing the speed at which a participant can place and remove pegs from a board.
Time frame: Initial Visit, First follow up, Second follow up
Motor Activity Log (MAL)
The Motor Activity Log (MAL) measures the amount and quality of spontaneous arm use in daily activities in stroke patients with hemiparesis, using patient-reported ratings on a structured questionnaire to assess real-world upper limb function.
Time frame: Initial Visit, First follow up, Second follow up
Open Point
Open Point measures proprioception in patients with impaired upper extremity function due to stroke. Cornella-Barba, G., Farrens, A. J., Johnson, C. A., Garcia-Fernandez, L., Chan, V., \& Reinkensmeyer, D. J. (2024). Using a Webcam to Assess Upper Extremity Proprioception: Experimental Validation and Application to Persons Post Stroke. Sensors (Basel, Switzerland), 24(23), 7434. https://doi.org/10.3390/s24237434
Time frame: Initial Visit, First follow up, Second follow up
NIH Stroke Scale
The NIH Stroke Scale (NIHSS) measures stroke severity by assessing neurological function, including consciousness, motor and sensory abilities, language, vision, and inattention to quantify impairment.
Time frame: Initial Visit, First follow up, Second follow up
Fatigue Severity Scale (FSS)
The Fatigue Severity Scale (FSS) measures the impact of fatigue on daily functioning and quality of life, assessing both the severity and the effect of fatigue on physical and cognitive activities through a self-reported questionnaire.
Time frame: Initial Visit, First follow up, Second follow up
Fugl-Meyer Sensory Assessment: Touch and Proprioception
The Fugl-Meyer Sensory Assessment evaluates sensory function in stroke patients by assessing light touch sensitivity and joint position sense (proprioception) in the affected limbs.
Time frame: Initial Visit, First follow up, Second follow up
Kinect: Sensor-based Upper Extremity Reachable Workspace Evaluation
The Kinect workspace measures the three-dimensional reachable space of the upper limb in hemiplegic stroke patients by tracking movement using a Kinect sensor, providing an objective assessment of functional reaching ability. Lee, Y. M., Lee, S., Uhm, K. E., Kurillo, G., Han, J. J., \& Lee, J. (2020). Upper Limb Three-Dimensional Reachable Workspace Analysis Using the Kinect Sensor in Hemiplegic Stroke Patients: A Cross-Sectional Observational Study. American journal of physical medicine \& rehabilitation, 99(5), 397-403. https://doi.org/10.1097/PHM.0000000000001350
Time frame: Initial Visit, First follow up, Second follow up
Geriatric Depression Scale
The Geriatric Depression Scale (GDS) is a screening tool designed to assess depressive symptoms in older adults.
Time frame: Initial Visit, First follow up, Second follow up
Intrinsic Motivation Inventory (IMI)
The Intrinsic Motivation Inventory (IMI) measures a person's subjective experience of motivation in a given activity, assessing factors such as interest/enjoyment, perceived competence, effort, value/usefulness, and relatedness through a self-report questionnaire.
Time frame: Initial Visit, First follow up, Second follow up
Modified Ashworth Spasticity Scale
The Modified Ashworth Spasticity Scale measures muscle spasticity by assessing resistance to passive movement in a limb, grading it on a scale from 0 (no increase in tone) to 4 (rigid in flexion or extension).
Time frame: Initial Visit, First follow up, Second follow up
Visual Analog of Pain Scale
Rating Pain on a scale of 1-10.
Time frame: Initial Visit, First follow up, Second follow up
Montreal Cognitive Assessment
The Montreal Cognitive Assessment (MoCA) is a screening tool that evaluates cognitive function by assessing domains such as memory, attention, language, visuospatial skills, and executive function to detect mild cognitive impairment.
Time frame: Initial Visit, First follow up, Second follow up
System Usability Scale
System Usability Scale is a short questionnaire that asks about your experience using a device or system.
Time frame: second visit
Plan to share: No — We do not plan to share Individual Participant Data (IPD) with external researchers to ensure compliance with UCI's data management requirements, maintain participant confidentiality, and restrict access to approved UCI researchers using only deidentified data within our institution
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of California, Irvine