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

NCT06787729 | Recruiting

• 2 other identifiers: 2024P0036285R01EB027777-05
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Stroke

Keywords

Hemiparesis; Upper extremity; Weakness; Arm; Hand; Ring Sensor; Wrist Sensor; mHealth; Stroke; Activities of daily living

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Motor Activity Log - Quality of Movement

  Week 0, Week 1, Week 4

• Use Ratio

  From enrollment to the end of the intervention period at 4 weeks

Other Outcomes (4)

• Fugl-Meyer Assessment, Upper Extremity - Motor

  Week 0, Week 1, Week 4

• Wolf Motor Function Test - Functional Ablility

  Week 0, Week 1, Week 4

• Wolf Motor Function Test - Performance Time

  Week 0, Week 1, Week 4

Study Arms (1)

mHealth Intervention

EXPERIMENTAL

Members of this group will receive the wearable sensors and mHealth smartphone application.

Device: mHealth

Interventions

mHealth DEVICE

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.

mHealth Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Massachusetts, Amherst: collaborator
• University of Maryland, College Park: collaborator
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator
• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Rehabilitation Hospital, Motion Analysis Laboratory

Charlestown, Massachusetts, 02474, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Paresis; Asthenia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paolo Bonato, PhD

  Director of Motion Analysis Laboratory

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathy Piela, PT, DPT

CONTACT

617-952-6388; kpiela@mgb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Motion Analysis Laboratory

Model Details: We will use the A (Baseline)-B (Intervention) design. Each participant will serve as their own control.

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 22, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)