Clinical trial NCT06787729: At Home Wearable Sensors and Smartphone for Stroke Survivors With Upper Limb Motor Challenges.
Official title: Motivation-Induced Movement Therapy: Enhancing Upper Limb Engagement in Stroke Survivors Through Ring Sensors and Data Visualization.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Hemiparesis
Upper extremity
Weakness
Arm
Hand
Ring Sensor
Wrist Sensor
mHealth
Stroke
Activities of daily living
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Amherst
name: University of Maryland, College Park
name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2025-01-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: We will use the A (Baseline)-B (Intervention)-A (Retention) or Reversal Design. Each participant will serve as their own control.
Primary purpose: TREATMENT

Brief summary: 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, intervention, and retention 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.

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)-A (Retention) or Reversal Design. The A-B-A design allows for an analysis of the effects of the introduction and subsequent removal of the intervention elements, while providing all participants an opportunity to experience the novel intervention components.

During the baseline phase (week 0 - week 2), study participants will wear the wrist and index finger-worn sensors, bilaterally, for a total of 14 days. The app will also allow study participants to self-annotate their activities approximately every 90 minutes.

During the intervention phase (week 2 - week 6), study participants will be asked to wear the wrist and/or index finger-worn sensors, bilaterally, for the next 4 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 3 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.

During the retention phase (week 6 - week 8), participants will be asked to wear the wrist and/or index finger-worn sensors, bilaterally, for the next 2 weeks. However, the mobile intervention and clinician interactions (i.e., weekly Zoom calls) will be removed, while participants continue to wear sensors to examine the effects of withdrawing feedback.

Clinical assessments will be completed after enrollment and following each phase.

Eligibility criteria: 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 \< 2.5.
* 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.

Primary outcomes:
measure: Motor Activity Log - Amount of Use
timeFrame: Week 0, Week 2, Week 6, Week 8
measure: Use Duration
timeFrame: From enrollment to the end of the retention period at 8 weeks
Secondary outcomes:
measure: Motor Activity Log - Quality of Movement
timeFrame: Week 0, Week 2, Week 6, Week 8
measure: Use Ratio
timeFrame: From enrollment to the end of the retention period at 8 weeks
Other outcomes:
measure: Fugl-Meyer Assessment, Upper Extremity - Motor
timeFrame: Week 0, Week 2, Week 6, Week 8
measure: Wolf Motor Function Test - Functional Ablility
timeFrame: Week 0, Week 2, Week 6, Week 8
measure: Wolf Motor Function Test - Performance Time
timeFrame: Week 0, Week 2, Week 6, Week 8
measure: Box and Block Test
timeFrame: Week 0, Week 2, Week 6, Week 8
Locations:
city: Charlestown
country: United States
facility: Spaulding Rehabilitation Hospital, Motion Analysis Laboratory
state: Massachusetts
Study officials:
affiliation: Director of Motion Analysis Laboratory
name: Paolo Bonato, PhD
role: PRINCIPAL_INVESTIGATOR
References: