At Home Wearable Sensors and Smartphone for Stroke Survivors With Upper Limb Motor Challenges.

Motivation-Induced Movement Therapy: Enhancing Upper Limb Engagement in Stroke Survivors Through Ring Sensors and Data Visualization.

The goal of this clinical trial is to learn if wearable sensor data visualization on smartphones can improve the use of the stroke-affected limb during everyday activities. Chronic stroke survivors (>12 months from onset) ages 18-80 years old with residual upper extremity motor impairments may be eligible to participate. The main question it aims to answer is:

Does the mobile health (mHealth) intervention help to improve the use of the stroke-affected upper-limb during daily living?

The study is designed so each participant serves as their own control. Researchers will compare information from the baseline and intervention time periods to see if visualizing the data on the smartphone impacts the participant's daily use of the arm.

Participants will be asked to wear a set of wearable ring and wrist sensors and interact with a custom-designed smartphone app, aiming to increase the use of their stroke-affected limb during daily activities as much as possible. They will receive feedback from the app, communicate with study therapists, participate in goal setting, complete clinical assessments, and share about their experience using the system during a virtual interview.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: mHealth

Detailed Description

To test the efficacy of the mHealth intervention elements (i.e., feedback, goal setting, and communication), we will use the A (Baseline)-B (Intervention) design. The A-B design allows for an analysis of the effects of the introduction of the intervention elements, while providing all participants an opportunity to experience the novel intervention components.

During the baseline phase (week 0 - week 1), study participants will wear the wrist and index finger-worn sensors, bilaterally, for a total of 7 days. The app will also allow study participants to self-annotate their activities approximately every 90 minutes.

During the intervention phase (week 1 - week 4), study participants will be asked to wear the wrist and/or index finger-worn sensors, bilaterally, for the next 3 weeks, similar to the baseline phase. The primary difference is that the patient will be asked to actively interact with the Intervention app, which will provide visualization of the patient's limb activity level. The platform will send auto-reminders to subjects every day at their preferred morning time to remind them to wear the wearable sensors and interact with the app. Using the sensor data collected from the wearable devices, the app will visualize the daily and weekly summary of the participants' limb activity data and the goals set by the therapist and patient. Additionally, the app will allow participants to annotate their activities and show the annotations along with the data. During the intervention phase, the participant will engage in 2 separate Zoom calls with a research therapist to 1) review the limb activity during the week, 2) discuss barriers to using the more impaired arm and ways to overcome them, 3) adjust the goal setting for the following week, and 4) document the discussions.

Clinical assessments will be completed after enrollment and following the intervention phase.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kathy Piela, PT, DPT; Phone Number: 617-952-6388; Email: kpiela@mgb.org

Study Locations

• United States
  • Massachusetts
    • Charlestown, Massachusetts, United States, 02474
      • Recruiting
      • Spaulding Rehabilitation Hospital, Motion Analysis Laboratory
      • Principal Investigator: Paolo Bonato, PhD
      • Contact: Kathy Piela, PT, DPT; Phone Number: 617-952-6388; Email: kpiela@mgb.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Stroke survivor (ischemic or hemorrhagic), >12 months post stroke, at the time of consent
• Aged between 18 and 80
• Ability to extend ≥ 10° at the metacarpophalangeal joint and one of the interphalangeal joints of each finger, ≥ 10° extension or abduction of the thumb, and ≥ 20° extension of the wrist from a fully flexed starting position.
• Demonstrating more affected arm nonuse, defined as a MAL-AoU score of </= 4.5.
• Actively uses at least one smartphone app.
• Strong beliefs towards being in control of their recovery, indicated by a score of ≤ 10 points on the Internal Recovery Locus of Control (I-RLOC) Scale.
• Participants must be able to read, write, and understand English at a level sufficient to comprehend study materials and provide informed consent.

Exclusion Criteria:

• Cognitive impairments that may affect the ability to understand and follow instructions (score < 24 in the Mini Mental State Examination)
• Difficulties comprehending numbers, dyslexia, severe aphasia, or other neurological conditions that prohibit the use of smartphones for safety reasons.
• Undergoing other types of motor therapy during the study period.
• Previous participation in constraint-induced movement therapy.
• Currently participating in or has participated in the past 3 months in any experimental rehabilitation or drug studies.
• Use of botulinum toxin for motor disability ≤ 3 months before treatment.
• Significant changes in pharmacological or treatment plans during the study period that may affect upper-limb use.
• Major medical problems that could interfere with participation.
• History of a disabling stroke (i.e., need more than minimum assistance to perform ADLs).
• Legally blind status.
• Uncontrolled seizures.
• Inability to don/doff sensors independently or with the assistance of a caregiver.
• Implantable medical devices that do not comply with the ISO 14117:2012 and/or ANSI/AAMI PC69 standards for electromagnetic compatibility. Subjects will be asked to provide their medical device record card, and non-compliant devices will result in exclusion from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: mHealth Intervention; Members of this group will receive the wearable sensors and mHealth smartphone application.

Device: mHealth; The experimental design is composed of two phases: baseline and intervention. During the first week (baseline), subjects will wear sensors, but no additional features (e.g., feedback, goal-setting, and weekly Zoom calls with clinicians) will be provided. For the next three weeks (intervention), subjects will wear sensors and have access to all intervention features, including weekly Zoom calls and goal-setting with clinicians. They will be encouraged to use the more impaired arm as much as possible.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor Activity Log - Amount of Use	This outcome measure assesses upper extremity function and use through patient report. Items are scored using a 6-point ordinal scale. For the Amount Scale, 0=the weaker arm was not used at all for that activity (not used), while 5=the weaker arm was used as often as before the stroke (same as pre-stroke). The score is calculated by adding the rating scores for each item and dividing by the number of items asked.	Week 0, Week 1, Week 4
Use Duration	This measure evaluates the duration for which a patient actively uses their stroke-affected limb during daily activities, as recorded by a wearable accelerometer placed on the stroke-affected index finger. The unit is minutes, with a range from 0 to 3600. A value of 0 indicates no use of the stroke-affected limb during the 24-hour period, while 3600 indicates continuous activity of the limb throughout the day. To compute Use Duration, the continuous accelerometer data is segmented into short intervals (e.g., one second), and the duration is calculated by counting the time intervals where the acceleration magnitude exceeds a threshold (e.g., > 1.134 g).	From enrollment to the end of the intervention period at 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor Activity Log - Quality of Movement	This outcome measure assesses upper extremity function and use through patient report. Items are scored using a 6-point ordinal scale. For the How Well Scale, 0=the weaker arm was not used at all for that activity (not used), while 5=the ability to use the weaker arm for that activity was as good as before the stroke (normal). The score is calculated by adding the rating scores for each item and dividing by the number of items asked.	Week 0, Week 1, Week 4
Use Ratio	This measure compares the activity levels of the stroke-affected limb to the less-affected limb. The range is from -log(3600) to log(3600). where -log(3600) indicates exclusive use of the stroke-affected limb, log(3600) indicates exclusive use of the less-affected limb, and 0 represents equal use of both limbs. Use Ratio is computed by first determining the Use Duration for both the stroke-affected and less-affected limbs using wearable accelerometers placed on their respective index fingers. The relationship is then calculated as the logarithm of the ratio of Use Durations: log(stroke-affected use duration/less-affected use duration).	From enrollment to the end of the intervention period at 4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer Assessment, Upper Extremity - Motor	This is a motor function assessment for stroke survivors who have hemiplegia. Items are scored on a 3-point ordinal scale where 0=cannot perform, 1=performs partially, and 2=performs fully. Higher scores are indicative of higher function. Maximum score=66.	Week 0, Week 1, Week 4
Wolf Motor Function Test - Functional Ablility	This assessment evaluates motor ability of the upper extremity during timed and functional tasks. Functional ability scores are assigned using a 6-point ordinal scale, and the maximum score is 75. A score of 0=does not attempt with the involved arm and a score of 5=arm does participate; movement appears to be normal. Higher scores are indicative of higher function.	Week 0, Week 1, Week 4
Wolf Motor Function Test - Performance Time	This assessment evaluates motor ability of the upper extremity during timed and functional tasks. Performance time is measured in seconds, with up to 120 seconds allowed.	Week 0, Week 1, Week 4
Box and Block Test	The test is an assessment of unilateral gross manual dexterity. It is performed with each hand separately, the stroke-affected hand and the non-affected hand. The scored is calculated by counting the number of blocks that were carried over the partition from one side of the box to the other side of the box in 1 minute. Higher scores are indicative of better gross manual dexterity.	Week 0, Week 1, Week 4

Collaborators and Investigators

• Sponsor: Spaulding Rehabilitation Hospital
• Collaborators: National Institute for Biomedical Imaging and Bioengineering (NIBIB); University of Massachusetts, Amherst; University of Maryland, College Park
• Investigators: Principal Investigator: Paolo Bonato, PhD, Director of Motion Analysis Laboratory

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: January 16, 2025
• First Submitted That Met QC Criteria: January 16, 2025
• First Posted (Actual): January 22, 2025

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Stroke; Activities of daily living; Upper extremity; mHealth; Hand; Hemiparesis; Arm; Weakness; Ring Sensor; Wrist Sensor
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Stroke; Paresis; Asthenia
• Other Study ID Numbers: 2024P003628; 5R01EB027777-05 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is not included in the study participant consent form.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No