University of California Irvine
Irvine, California, 92697, United States
Location status: Recruiting
Location contact
David Reinkensmeyer, PhD
PRINCIPAL_INVESTIGATOR
Vicky Chan, DPT
CONTACT
NCT Number: NCT07042152
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
Interested in participating?
Request Info18 year–84 year
All sexes
Interventional
Not applicable
Irvine, California, 92697, United States
Location status: Recruiting
David Reinkensmeyer, PhD
PRINCIPAL_INVESTIGATOR
Vicky Chan, DPT
CONTACT
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: From enrollment to the end of treatment and follow up measurement (9 weeks)
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)
This outcome measures the active time of the impaired upper extremity in minutes and hours.
Time frame: Initial Visit, First follow up, Second follow up
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
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
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
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 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
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
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
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
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
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
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
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
Rating Pain on a scale of 1-10.
Time frame: Initial Visit, First follow up, Second follow up
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: second visit
System Usability Scale is a short questionnaire that asks about your experience using a device or system.
Contact information is provided by the study sponsor or research team.
Natanya Gunn, Medical Student
CONTACT
Vicky Chan, DPT
CONTACT
University of California, Irvine
Other
Sensor Enhanced Activity Motivation After Stroke
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