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.
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.
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.
Single group
mHealth
DeviceThe 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.
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.
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).
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.
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).
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.
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.
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.
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.
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Spaulding Rehabilitation Hospital
Lead sponsor
University of Massachusetts, Amherst
Collaborator
University of Maryland, College Park
Collaborator
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Collaborator
