Chronic Stroke PatientsNCT07042152
Wearable Device and Behavioral Support for Enhancing Arm Use After Stroke
A study testing Smartwatch App for Movement Variability, Smartwatch App for Active Time and Motivational Interviewing (Within Subjects) in people with Chronic Stroke Patients, run by University of California, Irvine at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Chronic Stroke Patients
- What is being tested?
- Smartwatch App for Movement Variability, Smartwatch App for Active Time and Motivational Interviewing (Within Subjects)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2025to 29 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Natanya Gunn, Medical Student contact
United States1 site, 1 recruiting
- Recruiting
University of California Irvine
Irvine, California, 92697
Vicky Chan, DPT, 949-824-8423, vchan2@uci.edu
David Reinkensmeyer, PhD
About this study
Official title: Sensor Enhanced Activity Motivation 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
Read the 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
- Conditions
- Chronic Stroke Patients
- Being tested
- Smartwatch App for Movement Variability, Smartwatch App for Active Time, Motivational Interviewing (Within Subjects)
- Keywords
- Sensor, SmartWatch, Stroke Recovery, Stroke Rehabilitation, Motivational Interviewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Movement Variability | Experimental | The movement variability group will have a smartwatch app that records movement variability. Their movement goal will be centered on increasing their total movement variability as measured by the watch. Receives: Other: Smartwatch App for Movement Variability; Behavioral: Motivational Interviewing (Within Subjects) |
| Active Time (Control) | Placebo comparator | This group will only receive active-time feedback (the number of minutes and hours moving the upper extremity). Their goal will focus on increasing their total movement time. Receives: Other: Smartwatch App for Active Time; Behavioral: Motivational Interviewing (Within Subjects) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variability Measurement
The amount of variability for the impaired upper extremity will be quantified by the variety of movements performed.
Measured: From enrollment to the end of treatment and follow up measurement (9 weeks)
Secondary outcomes (10)
Active Time
This outcome measures the active time of the impaired upper extremity in minutes and hours.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Initial Visit, First follow up, Second follow up
Open Point
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
Measured: Initial Visit, First follow up, Second follow up
NIH Stroke Scale
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.
Measured: Initial Visit, First follow up, Second follow up
Fatigue Severity Scale (FSS)
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.
Measured: Initial Visit, First follow up, Second follow up
Fugl-Meyer Sensory Assessment: Touch and Proprioception
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.
Measured: Initial Visit, First follow up, Second follow up
Kinect: Sensor-based Upper Extremity Reachable Workspace Evaluation
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
Measured: Initial Visit, First follow up, Second follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start20 Aug 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion29 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Stroke PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Reinkensmeyer, University of California, Irvine
- Investigators
- David Reinkensmeyer, PhD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042152
- Sponsor's protocol ID
- 2621
- Status last verified
- Aug 2025
- First submitted
- 19 May 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share Individual Participant Data (IPD) with external researchers to ensure compliance with UCI's data management requirements, maintain participant confidentiality, and restrict access to approved UCI researchers using only deidentified data within our institution
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.
PubMed 36146287
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensor Enhanced Activity Motivation After Stroke
- ClinicalTrials.gov ID
- NCT07042152
- Acronym / sponsor ID
- 2621
- Conditions
- Chronic Stroke Patients
- Keywords
- Sensor, SmartWatch, Stroke Recovery, Stroke Rehabilitation, Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 20 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 29 Jan 2026 (estimated)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Movement Variability | Experimental | Other: Smartwatch App for Movement Variability, Behavioral: Motivational Interviewing (Within Subjects)The movement variability group will have a smartwatch app that records movement variability. Their movement goal will be centered on increasing their total movement variability as measured by the watch. |
| Active Time (Control) | Placebo comparator | Other: Smartwatch App for Active Time, Behavioral: Motivational Interviewing (Within Subjects)This group will only receive active-time feedback (the number of minutes and hours moving the upper extremity). Their goal will focus on increasing their total movement time. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartwatch App for Movement VariabilityThis app measures movement variability in the upper extremity as described in our previous study (doi:10.3390/s24165266). | Other | Movement Variability |
| Smartwatch App for Active TimeThe other software we are using measures total active time of the upper extremity. | Other | Active Time (Control) |
| 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. | Behavioural | Active Time (Control), Movement Variability |
Primary outcome
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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Background: PubMed 36146287Schwerz 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.
- Individual participant dataSharing planned: No. We do not plan to share Individual Participant Data (IPD) with external researchers to ensure compliance with UCI's data management requirements, maintain participant confidentiality, and restrict access to approved UCI researchers using only deidentified data within our institution
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Natanya Gunn, Medical Student contact
David Reinkensmeyer, PhD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartwatch App for Movement Variability, Smartwatch App for Active Time and Motivational Interviewing (Within Subjects) in people with Chronic Stroke Patients, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vicky Chan, DPT (9498248423, vchan2@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variability Measurement (time frame: From enrollment to the end of treatment and follow up measurement (9 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07042152, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.