No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
Spaulding Rehabilitation Hospital · Other
Who this trial is looking for
This trial is looking for stroke survivors aged 18 to 80 who have difficulty using one arm. Participants will wear sensors and use a smartphone app to help improve arm use in daily activities.
Are You a Good Fit for This Trial?
Rules you outSevere cognitive impairmentSevere dyslexiaSevere aphasiaLegally blindUncontrolled seizures
You may be able to join if
I am a stroke survivor over 12 months post-stroke.
I am between 18 and 80 years old.
I can move my fingers and wrist to certain degrees.
I have limited use of my affected arm.
I actively use at least one smartphone app.
I believe I can control my recovery.
I can read and understand English.
You may not be able to join if
I have cognitive impairments that affect my understanding.
I have serious difficulties with numbers or reading.
I am receiving other motor therapy during the study.
I have participated in certain movement therapy before.
I have recently taken part in other rehabilitation studies.
I have had botulinum toxin treatment in the last 3 months.
I have major health issues that interfere with participation.
I can't put on or take off the sensors independently.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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) in…
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.
Trial Locations
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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 ≥…
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.
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