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NCT Number: NCT07042152

Wearable Device and Behavioral Support for Enhancing Arm Use After Stroke

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

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Key information

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Irvine

Irvine, California, 92697, United States

Location status: Recruiting

Location contact

David Reinkensmeyer, PhD

PRINCIPAL_INVESTIGATOR

Vicky Chan, DPT

CONTACT

[email protected]

949-824-8423

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

Primary outcomes

  1. Variability Measurement

    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.

Secondary outcomes

  1. Active Time

    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.

  2. Fugl-Meyer Arm Motor Assessment

    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.

  3. Box and Blocks Test

    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.

  4. Nine Hole Peg Test

    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.

  5. Motor Activity Log (MAL)

    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.

  6. Open Point

    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

  7. NIH Stroke Scale

    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.

  8. Fatigue Severity Scale (FSS)

    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.

  9. Fugl-Meyer Sensory Assessment: Touch and Proprioception

    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.

  10. Kinect: Sensor-based Upper Extremity Reachable Workspace Evaluation

    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

Other outcomes

  1. Geriatric Depression Scale

    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.

  2. Intrinsic Motivation Inventory (IMI)

    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.

  3. Modified Ashworth Spasticity Scale

    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).

  4. Visual Analog of Pain Scale

    Time frame: Initial Visit, First follow up, Second follow up

    Rating Pain on a scale of 1-10.

  5. Montreal Cognitive Assessment

    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.

  6. System Usability Scale

    Time frame: second visit

    System Usability Scale is a short questionnaire that asks about your experience using a device or system.

Study contacts

Contact information is provided by the study sponsor or research team.

Natanya Gunn, Medical Student

CONTACT

[email protected]

Vicky Chan, DPT

CONTACT

[email protected]

9498248423

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

Sensor Enhanced Activity Motivation After Stroke

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jun 27, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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