Recruiting

mHealth Intervention

Sponsor:

Spaulding Rehabilitation Hospital

Code:

NCT06787729

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

mHealth

Study Details

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

Study ID

NCT06787729

Start date

Apr 20, 2026

Status verified date

Jul, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: mHealth Intervention

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

Interventions

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.

Primary outcome measure

  • Motor Activity Log - Amount of Use [ Time Frame: Week 0, Week 1, Week 4 ]
  • Use Duration [ Time Frame: From enrollment to the end of the intervention period at 4 weeks ]

Central Contacts and Locations

Central contacts

Kathy Piela, PT, DPT

617-952-6388kpiela@mgb.org

Locations

Spaulding Rehabilitation Hospital, Motion Analysis Laboratory

Recruiting

Charlestown, Massachusetts, United States, 02474

Contacts

Kathy Piela, PT, DPT

617-952-6388kpiela@mgb.org

Principal Investigator:

Paolo Bonato, PhD

More Information

Sponsor

Spaulding Rehabilitation Hospital

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Spaulding Rehabilitation Hospital on 2026-07-13.