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Recruiting NCT07042152

Wearable Device and Behavioral Support for Enhancing Arm Use After Stroke

No phase Interventional Chronic Stroke Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Smartwatch App for Movement Variability, Smartwatch App for Active Time, Motivational Interviewing (Within Subjects).
Who it may be relevant to
Registry conditions: Chronic Stroke Patients. Basic parameters: 18 years — 84 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Sensor Enhanced Activity Motivation After Stroke

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

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

  • Other Smartwatch App for Movement Variability
    This app measures movement variability in the upper extremity as described in our previous study (doi:10.3390/s24165266).
  • Other Smartwatch App for Active Time
    The other software we are using measures total active time of the upper extremity.
  • Behavioral Motivational 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.

Primary outcome measures

  • Variability Measurement [Time frame: From enrollment to the end of treatment and follow up measurement (9 weeks)]
Secondary outcome measures (10)
  • Active Time [Time frame: From enrollment to the end of treatment and follow up measurement (9 weeks)]
  • Fugl-Meyer Arm Motor Assessment [Time frame: Initial Visit, First follow up, Second follow up]
  • Box and Blocks Test [Time frame: Initial Visit, First follow up, second follow up]
  • Nine Hole Peg Test [Time frame: Initial Visit, First follow up, Second follow up]
  • Motor Activity Log (MAL) [Time frame: Initial Visit, First follow up, Second follow up]
  • Open Point [Time frame: Initial Visit, First follow up, Second follow up]
  • NIH Stroke Scale [Time frame: Initial Visit, First follow up, Second follow up]
  • Fatigue Severity Scale (FSS) [Time frame: Initial Visit, First follow up, Second follow up]
  • Fugl-Meyer Sensory Assessment: Touch and Proprioception [Time frame: Initial Visit, First follow up, Second follow up]
  • Kinect: Sensor-based Upper Extremity Reachable Workspace Evaluation [Time frame: Initial Visit, First follow up, Second follow up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of California Irvine — Irvine

Publications

  • 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. PMID 36146287

Identifiers

NCT: NCT07042152 · 2621

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗