Wearable Device and Behavioral Support for Enhancing Arm Use After Stroke
ConditionChronic Stroke Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-84
SponsorUniversity of California, Irvine
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Smartwatch App for Movement Variability
Other interventionThis app measures movement variability in the upper extremity as described in our previous study (doi:10.3390/s24165266).
Smartwatch App for Active Time
Other interventionThe other software we are using measures total active time of the upper extremity.
Motivational Interviewing (Within Subjects)
BehavioralMotivational 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.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Movement VariabilityExperimental treatment 2 interventions
Group B: Active Time (Control)Placebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
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
1
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)2
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 up3
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 up4
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 upOther outcomes
1
Geriatric Depression Scale
The Geriatric Depression Scale (GDS) is a screening tool designed to assess depressive symptoms in older adults.
Time frame
Initial Visit, First follow up, Second follow up2
Intrinsic Motivation Inventory (IMI)
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.
Time frame
Initial Visit, First follow up, Second follow up3
Modified Ashworth Spasticity Scale
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).
Time frame
Initial Visit, First follow up, Second follow up4
Visual Analog of Pain Scale
Rating Pain on a scale of 1-10.
Time frame
Initial Visit, First follow up, Second follow upSponsors and contacts
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Source ClinicalTrials.gov