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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Movement Variability | Experimental | 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. |
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| Active Time (Control) | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartwatch App for Movement Variability | Other | This app measures movement variability in the upper extremity as described in our previous study (doi:10.3390/s24165266). |
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| Measure | Description | Time Frame |
|---|---|---|
| Variability Measurement | The amount of variability for the impaired upper extremity will be quantified by the variety of movements performed. | From enrollment to the end of treatment and follow up measurement (9 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Active Time | This outcome measures the active time of the impaired upper extremity in minutes and hours. | From enrollment to the end of treatment and follow up measurement (9 weeks) |
| Fugl-Meyer Arm Motor Assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Geriatric Depression Scale | The Geriatric Depression Scale (GDS) is a screening tool designed to assess depressive symptoms in older adults. | Initial Visit, First follow up, Second follow up |
| Intrinsic Motivation Inventory (IMI) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vicky Chan, DPT | Contact | 9498248423 | vchan2@uci.edu | |
| Natanya Gunn, Medical Student | Contact | natanyag@hs.uci.edu |
| Name | Affiliation | Role |
|---|---|---|
| David Reinkensmeyer, PhD | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Irvine | Recruiting | Irvine | California | 92697 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36146287 | Background | Schwerz de Lucena D, Rowe JB, Okita S, Chan V, Cramer SC, Reinkensmeyer DJ. Providing Real-Time Wearable Feedback to Increase Hand Use after Stroke: A Randomized, Controlled Trial. Sensors (Basel). 2022 Sep 14;22(18):6938. doi: 10.3390/s22186938. |
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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
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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Single (Outcomes Assessor)
| Smartwatch App for Active Time | Other | The other software we are using measures total active time of the upper extremity. |
|
| Motivational Interviewing (Within Subjects) | Behavioral | 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. |
|
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.
| 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. | 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. | 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. | 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 | 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. | 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. | 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. | 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 | 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.
| 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). | Initial Visit, First follow up, Second follow up |
| Visual Analog of Pain Scale | Rating Pain on a scale of 1-10. | 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. | 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. | second visit |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |