Wearable Device and Behavioral Support for Enhancing Arm Use After Stroke

Not Applicable

Not yet recruiting

• Conditions: Chronic Stroke Patients

• Registration Number: NCT07042152
• Lead Sponsor: University of California, Irvine

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

Study Timeline

• Study First Submitted: 2025-05-19
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-19
• Last Update Submitted: 2025-06-19
• Study First Posted: 2025-06-27
• Last Update Posted: 2025-06-27
• Study Start: 2025-07-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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

Trial Locations

Locations (1)

University of California Irvine; 🇺🇸 Irvine, California, United States