Trial Outcomes & Findings for Addressing Arm Non-use by Encouraging Idle-time Activity During Early Recovery From Stroke (NCT NCT05900999)
NCT ID: NCT05900999
Last Updated: 2026-01-16
Results Overview
The RAAD assesses the amount of measured arm activity during cued exercise epochs compared to non-cued epochs. A RAAD value greater than 1.0 indicates that the amount of arm activity in response to Souvenir cues exceeded the amount of activity during non-cued periods of time.
COMPLETED
NA
42 participants
During device use in an inpatient setting (about 1 to 3 weeks of use).
2026-01-16
Participant Flow
Recruitment dates: 11/29/2022 through 7/18/2023. Recruitment location: inpatient rehabilitation facility
Participant milestones
| Measure |
Survivors of Stroke in Early Stages of Recovery
This was a single cohort study. We evaluated the feasibility, functional utility, and subjective user experience of a progressive-challenge cued activity program, delivered via wearable technology, to promote upper limb activity in an inpatient rehabilitation facility during the early days and weeks following stroke.
Quantitative movement data was collected using accelerometry (motion trackers worn on both wrists) to estimate compliance with the cue responses. We assessed user experience using validated quantitative surveys that measure motivation to engage with the system, perceptions of system usability, and the degree of user satisfaction while using the technology.
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|---|---|
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Overall Study
STARTED
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42
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Overall Study
COMPLETED
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30
|
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Overall Study
NOT COMPLETED
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12
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Reasons for withdrawal
| Measure |
Survivors of Stroke in Early Stages of Recovery
This was a single cohort study. We evaluated the feasibility, functional utility, and subjective user experience of a progressive-challenge cued activity program, delivered via wearable technology, to promote upper limb activity in an inpatient rehabilitation facility during the early days and weeks following stroke.
Quantitative movement data was collected using accelerometry (motion trackers worn on both wrists) to estimate compliance with the cue responses. We assessed user experience using validated quantitative surveys that measure motivation to engage with the system, perceptions of system usability, and the degree of user satisfaction while using the technology.
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|---|---|
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Overall Study
Withdrawal by Subject
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9
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Overall Study
transfer to another facility; too complex of a therapy schedule; physician withdrawal
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3
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Baseline Characteristics
12 participants withdrew or were withdrawn
Baseline characteristics by cohort
| Measure |
Survivors of Stroke in Early Stages of Recovery
n=42 Participants
This was a single cohort study. We evaluated the feasibility, functional utility, and subjective user experience of a progressive-challenge cued activity program, delivered via wearable technology, to promote upper limb activity in an inpatient rehabilitation facility during the early days and weeks following stroke.
Quantitative movement data was collected using accelerometry (motion trackers worn on both wrists) to estimate compliance with the cue responses. We assessed user experience using validated quantitative surveys that measure motivation to engage with the system, perceptions of system usability, and the degree of user satisfaction while using the technology.
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|---|---|
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Age, Continuous
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63.2 Years
STANDARD_DEVIATION 14.5 • n=42 Participants
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Sex: Female, Male
Female
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17 Participants
n=42 Participants
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Sex: Female, Male
Male
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25 Participants
n=42 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=42 Participants
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Race (NIH/OMB)
Asian
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=42 Participants
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Race (NIH/OMB)
Black or African American
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13 Participants
n=42 Participants
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|
Race (NIH/OMB)
White
|
28 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=42 Participants
|
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Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=42 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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41 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=42 Participants
|
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Montreal Cognitive Assessment (MoCA)
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25.9 numerical score (ordinal)
STANDARD_DEVIATION 4.2 • n=30 Participants • 12 participants withdrew or were withdrawn
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Fugl-Meyer Upper Extremity Motor Score
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45.6 numerical score (ordinal)
STANDARD_DEVIATION 25.1 • n=42 Participants
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Fugl-Meyer Upper Extremity Sensory Score
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11.5 numerical score (ordinal)
STANDARD_DEVIATION 1.7 • n=42 Participants
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PRIMARY outcome
Timeframe: During device use in an inpatient setting (about 1 to 3 weeks of use).Population: Of the 42 recruited participants, 12 withdrew or were withdrawn. Reasons for withdrawal included: disliking the vibrotactile cues after initial demonstration with the device (4), disliking the cues after 1-2 days of use (5), transfer of care to outside facility (1), complex therapy schedule (1), and physician withdraw (1).
The RAAD assesses the amount of measured arm activity during cued exercise epochs compared to non-cued epochs. A RAAD value greater than 1.0 indicates that the amount of arm activity in response to Souvenir cues exceeded the amount of activity during non-cued periods of time.
Outcome measures
| Measure |
Survivors of Stroke in Early Stages of Recovery
n=30 Participants
This was a single cohort study. We evaluated the feasibility, functional utility, and subjective user experience of a progressive-challenge cued activity program, delivered via wearable technology, to promote upper limb activity in an inpatient rehabilitation facility during the early days and weeks following stroke.
Quantitative movement data was collected using accelerometry (motion trackers worn on both wrists) to estimate compliance with the cue responses. We assessed user experience using validated quantitative surveys that measure motivation to engage with the system, perceptions of system usability, and the degree of user satisfaction while using the technology.
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|---|---|
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Ratio of Average Activity Duration (RAAD)
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1.223 ratio
Standard Deviation 0.63
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PRIMARY outcome
Timeframe: Two time points: After device use in an inpatient setting (after about 1 to 3 weeks of use); after device use in home settings (after 2 days of use).Population: Of the 42 recruited participants, 12 withdrew or were withdrawn. Reasons for withdrawal included: disliking the vibrotactile cues after initial demonstration with the device (4), disliking the cues after 1-2 days of use (5), transfer of care to outside facility (1), complex therapy schedule (1), and physician withdraw (1).
The System Usability Scale (SUS) assesses the usability of the activity cueing system and monitoring system within the context of encouraging therapeutic arm activity. Scores are provided on a scale ranging from 1 to 100, with higher scores indicating greater perceived usability. Scores greater than 68 are generally considered to indicate "passable" usability.
Outcome measures
| Measure |
Survivors of Stroke in Early Stages of Recovery
n=30 Participants
This was a single cohort study. We evaluated the feasibility, functional utility, and subjective user experience of a progressive-challenge cued activity program, delivered via wearable technology, to promote upper limb activity in an inpatient rehabilitation facility during the early days and weeks following stroke.
Quantitative movement data was collected using accelerometry (motion trackers worn on both wrists) to estimate compliance with the cue responses. We assessed user experience using validated quantitative surveys that measure motivation to engage with the system, perceptions of system usability, and the degree of user satisfaction while using the technology.
|
|---|---|
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System Usability Scale
SUS obtained after using the device in an inpatient setting
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80.1 units on a scale
Standard Deviation 13.8
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System Usability Scale
SUS obtained after using the device in home settings
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83.3 units on a scale
Standard Deviation 15.2
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PRIMARY outcome
Timeframe: After device use in an inpatient setting (after about 1 to 3 weeks of use).Population: Of the 42 recruited participants, 12 withdrew or were withdrawn. Reasons for withdrawal included: disliking the vibrotactile cues after initial demonstration with the device (4), disliking the cues after 1-2 days of use (5), transfer of care to outside facility (1), complex therapy schedule (1), and physician withdraw (1).
The IMI assesses subjective experience of motivation in response to the system's vibrotactile cues. IMI comprises 37 questions, with answers provided on a Likert scale (1-7). IMI questions span 6 psychosocial dimensions: * interest/enjoyment; higher scores = more interest/enjoyment with cued activities * effort/importance; higher scores = more perceived importance and more effort put into performing cued activities * value/usefulness higher scores = more perceived value and usefulness of cued activities * perceived choice; higher scores = greater degree to which participants felt that they had choice in engaging with the cued activities * perceived competence; higher scores = greater degree of competence performing cued activities * pressure/tension; higher scores = more anxiety/tension performing cued activities. A composite score is computed within each dimension by averaging item responses after reversing specified negative items; a score of 4 separates (+) from (-) experiences.
Outcome measures
| Measure |
Survivors of Stroke in Early Stages of Recovery
n=30 Participants
This was a single cohort study. We evaluated the feasibility, functional utility, and subjective user experience of a progressive-challenge cued activity program, delivered via wearable technology, to promote upper limb activity in an inpatient rehabilitation facility during the early days and weeks following stroke.
Quantitative movement data was collected using accelerometry (motion trackers worn on both wrists) to estimate compliance with the cue responses. We assessed user experience using validated quantitative surveys that measure motivation to engage with the system, perceptions of system usability, and the degree of user satisfaction while using the technology.
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|---|---|
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Intrinsic Motivation Inventory (IMI)
interest/enjoyment dimension
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4.9 units on a scale
Standard Deviation 1.3
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Intrinsic Motivation Inventory (IMI)
effort/importance dimension
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5.4 units on a scale
Standard Deviation 1.4
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Intrinsic Motivation Inventory (IMI)
value/usefulness dimension
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6.2 units on a scale
Standard Deviation 0.9
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Intrinsic Motivation Inventory (IMI)
perceived choice dimension
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6.0 units on a scale
Standard Deviation 0.9
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Intrinsic Motivation Inventory (IMI)
perceived competence dimension
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5.8 units on a scale
Standard Deviation 1.2
|
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Intrinsic Motivation Inventory (IMI)
pressure/tension dimension
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2.8 units on a scale
Standard Deviation 1.0
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PRIMARY outcome
Timeframe: Two time points: After device use in an inpatient setting (after about 1 to 3 weeks of use); after device use in home settings (after 2 days of use).Population: Of the 42 recruited participants, 12 withdrew or were withdrawn. Reasons for withdrawal included: disliking the vibrotactile cues after initial demonstration with the device (4), disliking the cues after 1-2 days of use (5), transfer of care to outside facility (1), complex therapy schedule (1), and physician withdraw (1).
The QUEST assesses user satisfaction with the system and its delivery by the research team.. The QUEST comprises 12 questions, with answers provided on a Likert scale (1-5). For each question, a score of "1" = not at all satisfied where "5" is "very satisfied". A composite score (min = 1; max = 5) is computed for the QUEST by averaging across all questions. A score of 3 separates (+) from (-) experiences.
Outcome measures
| Measure |
Survivors of Stroke in Early Stages of Recovery
n=30 Participants
This was a single cohort study. We evaluated the feasibility, functional utility, and subjective user experience of a progressive-challenge cued activity program, delivered via wearable technology, to promote upper limb activity in an inpatient rehabilitation facility during the early days and weeks following stroke.
Quantitative movement data was collected using accelerometry (motion trackers worn on both wrists) to estimate compliance with the cue responses. We assessed user experience using validated quantitative surveys that measure motivation to engage with the system, perceptions of system usability, and the degree of user satisfaction while using the technology.
|
|---|---|
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Quebec User Evaluation of Satisfaction With Technology (QUEST)
QUEST post-device use in an inpatient setting
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4.52 units on a scale
Standard Deviation 0.46
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Quebec User Evaluation of Satisfaction With Technology (QUEST)
QUEST after use in home settings
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4.5 units on a scale
Standard Deviation 0.5
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Adverse Events
Survivors of Stroke in Early Stages of Recovery
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place