Wearable Device and Behavioral Support for Enhancing Arm Use After Stroke

University of California, Irvine32 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Chronic Stroke Patients

Interventions

Smartwatch App for Movement VariabilityOTHER

This app measures movement variability in the upper extremity as described in our previous study (doi:10.3390/s24165266).

Smartwatch App for Active TimeOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 84 Years

Medical Language ↔ Plain English

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

Locations (1)

University of California Irvine

Irvine, California, United States

RECRUITING

Outcomes

Primary Outcomes

Variability Measurement

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)

Secondary Outcomes

Active Time

This outcome measures the active time of the impaired upper extremity in minutes and hours.

Time frame: From enrollment to the end of treatment and follow up measurement (9 weeks)

Fugl-Meyer Arm Motor Assessment

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

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.

Time frame: 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.

Time frame: 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.

Central Contacts

Vicky Chan, DPT

CONTACT

9498248423 vchan2@uci.edu

Natanya Gunn, Medical Student

CONTACT

natanyag@hs.uci.edu

Data from ClinicalTrials.gov

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