Chronic Stroke Patients
Conditions
Keywords
Sensor, SmartWatch, Stroke Recovery, Stroke Rehabilitation, Motivational Interviewing
Brief summary
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
Detailed description
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
Interventions
OTHERSmartwatch App for Movement Variability
This app measures movement variability in the upper extremity as described in our previous study (doi:10.3390/s24165266).
OTHERSmartwatch App for Active Time
The other software we are using measures total active time of the upper extremity.
BEHAVIORALMotivational Interviewing (Within Subjects)
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.
Sponsors
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Single (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 85 years of age * Experienced a single or multiple, ischemic or hemorrhagic stroke, with unilateral weakness, over six months previously * An ability to score at least 3 blocks on the Box and Block Test. BBT score of the affected arm is at least 5% worse than that present with the unaffected arm. * Absence of major depression, as defined by DSM V criteria or a score on the Geriatric Depression Scale \< 10.
Exclusion criteria
* Any substantial decrease in alertness, language reception, or attention * Single or multiple, ischemic or hemorrhagic stroke less than 6 months ago * Severe muscle tone at the upper extremity (score ≥ 3 on the Modified Ashworth Spasticity scale) * Pregnant or lactating * Advanced liver, kidney, cardiac, or pulmonary disease * Coexistent major neurological disease * Coexistent major psychiatric disease * Plans to alter any current participation in other rehabilitation therapy in the time period of the study * A terminal medical diagnosis consistent with survival \< 1 year * A history of significant alcohol or drug abuse in the prior 3 years * Current enrollment in another study related to stroke or stroke recovery * Any other medical contraindication to participation in the study, as evaluated by our team physician. * Visual Analog of Pain Scale Score of 7 or greater
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variability Measurement | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Arm Motor Assessment | 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. |
| Motor Activity Log (MAL) | 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. |
| Open Point | 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 |
| NIH Stroke Scale | 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. |
| Fatigue Severity Scale (FSS) | 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. |
| Fugl-Meyer Sensory Assessment: Touch and Proprioception | 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. |
| Kinect: Sensor-based Upper Extremity Reachable Workspace Evaluation | 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 |
| Nine Hole Peg Test | 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. |
| Active Time | 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. |
| Box and Blocks Test | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Modified Ashworth Spasticity Scale | 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). |
| Visual Analog of Pain Scale | Initial Visit, First follow up, Second follow up | Rating Pain on a scale of 1-10. |
| Montreal Cognitive Assessment | 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. |
| System Usability Scale | second visit | System Usability Scale is a short questionnaire that asks about your experience using a device or system. |
| Geriatric Depression Scale | 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. |
| Intrinsic Motivation Inventory (IMI) | 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. |
Countries
United States
Contacts
Primary ContactVicky Chan, DPT
Backup ContactNatanya Gunn, Medical Student
Outcome results
None listed