Inpatient Stroke Recovery Using Sensors
ConditionStroke
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShirley Ryan AbilityLab
About this trial
This observational trial seeks to assess the feasibility of using non-invasive, portable, real-time body-worn sensors to continuously monitor, quantify, and interpret recovery during inpatient treatment of stroke
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patient group
Individuals diagnosed with stroke admitted to the Shirley Ryan AbilityLab (inpatient), or individuals in the community who had a stroke (chronic)
Age 18 or older
Able and willing to give written consent and comply with study procedures
Disqualifiers
Patient group
Neurological degenerative pathologies as co-morbidities (such as multiple sclerosis, Alzheimer's disease, Parkinson's disease, etc.)
Pregnant or nursing
Skin allergies or irritation; open wounds
Trial population
The patient cohort will consist of stroke survivors both admitted as inpatients to the Shirley Ryan AbilityLab and individuals in the community who had a stroke. The healthy control cohort will be recruited from the community sample.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Wearable sensors
Diagnostic testUtilizing wireless wearable sensors, to capture quantitative biometric and movement-based data.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Patient Group1 intervention
Group B: Healthy Control Group1 intervention
Trial outcomes
Primary outcomes
1
Discharge clinical scores estimation
Error between clinical scores estimated from machine learning algorithms trained on sensor data from the Admission time-point, and true scores assessed at the discharge from the hospital.
Time frame
Discharge from inpatient stay. Average length of stay is 22 days.Secondary outcomes
1
Change in 6-Minute Walk Test (6MWT)
The 6MWT measures the distance a subject can walk indoors on a flat, hard surface in 6 minutes, using assistive devices as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The minimal detectable change for people with sub-acute stroke is 60.98 meters. Wearable sensors are used to monitor the movement of the subject during the test.
Time frame
From Admission time-point to 1-2 weeks, 1 month, 3 months, 6 months, 12 months post-stroke2
Change in 10-Meter Walk Test (10MWT)
The 10MWT measures the amount of time it takes to walk 10 meters. Time will be recorded using a stopwatch and recorded to the one hundredth of a second. The effects of acceleration and deceleration are minimized by adding 1 meter at the beginning and end of the course to isolate the subject's steady state speed. The test will be recorded 3 times each at a normal self-selected pace and at a faster pace, with adequate rest in between. Results will be averaged from 3 trials. Any assistive devices or orthotics should be kept consistent throughout and documented. Wearable sensors are used to monitor the movement of the subject during the test.
Time frame
From Admission time-point to 1-2 weeks, 1 month, 3 months, 6 months, 12 months post-stroke3
Change in Berg Balance Scale (BBS)
The BBS is a 14-item test, scored on a 5-level ordinal scale and validated against length of stay and discharge destination for stroke patients. The total score is expressed as a number between 0 and 56, where lower score mean increased balance impairment. It measures functional balance in a clinical setting during static and dynamic tasks (sitting, standing, transitioning from sit to stand, etc.). Wearable sensors are used to monitor the movement of the subject during the test.
Time frame
From Admission time-point to 1-2 weeks, 1 month, 3 months, 6 months, 12 months post-stroke4
Change in Timed Up and Go (TUG)
The TUG assesses mobility by measuring the time a person take to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. It can detect longitudinal changes in mobility in stroke patients. The subject wears their routine footwear and orthotics and can use their mobility aids. Wearable sensors are used to monitor the movement of the subject during the test.
Time frame
From Admission time-point to 1-2 weeks, 1 month, 3 months, 6 months, 12 months post-strokeSponsors and contacts
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Source ClinicalTrials.gov