Trial Outcomes & Findings for Smartphone and 3D Printing Based Home Rehabilitation System for Chronic Stroke (NCT NCT04363944)
NCT ID: NCT04363944
Last Updated: 2024-01-23
Results Overview
The total number of repetitions each participant completed for each activity in mRehab during the 6 week home program was recorded. The average total number of repetitions completed for each activity is reported.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
6 week in-home program
Results posted on
2024-01-23
Participant Flow
Participant milestones
| Measure |
Use of mRehab in a Home Program
mRehab incorporates a task-oriented approach and immediate performance-based feedback and longitudinal data. mRehab consists of 3D-printed household items integrated with a smartphone and an app that guides participants through practice of ADLs.
Single subject design with varying lengths of baseline data acquisition and follow-up data acquisition 2 visits to establish baseline Intervention: 6-week in home training program using mRehab 2 visits to establish performance immediately following intervention and 1-3 weeks post. Participants that completed baseline data acquisition, training and follow up were included in the final analyses. If a participant used hand over hand to complete all mrehab activities. Their data was not included in the analyses.
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Use of mRehab in Home Completing All Activities Bilaterally
Participant completed all activities in the six week in home mRehab program bilaterally.
|
|---|---|---|
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Overall Study
STARTED
|
18
|
1
|
|
Overall Study
COMPLETED
|
16
|
1
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Use of mRehab in a Home Program
mRehab incorporates a task-oriented approach and immediate performance-based feedback and longitudinal data. mRehab consists of 3D-printed household items integrated with a smartphone and an app that guides participants through practice of ADLs.
Single subject design with varying lengths of baseline data acquisition and follow-up data acquisition 2 visits to establish baseline Intervention: 6-week in home training program using mRehab 2 visits to establish performance immediately following intervention and 1-3 weeks post. Participants that completed baseline data acquisition, training and follow up were included in the final analyses. If a participant used hand over hand to complete all mrehab activities. Their data was not included in the analyses.
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Use of mRehab in Home Completing All Activities Bilaterally
Participant completed all activities in the six week in home mRehab program bilaterally.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
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Baseline Characteristics
Smartphone and 3D Printing Based Home Rehabilitation System for Chronic Stroke
Baseline characteristics by cohort
| Measure |
Use of mRehab in a Home Program
n=16 Participants
mRehab incorporates a task-oriented approach and immediate performance-based feedback. mRehab consists of 3D-printed household items integrated with a smartphone and an app. The app guides participants through practice of activities of daily living. In each session of exercise participants receive feedback on the number of repetitions they complete for each activity, the average time to complete the activity and the average smoothness to perform the activity. Participants were trained in use of mRehab in lab visits and then took mRehab home to use the system. mRehab recorded longitudinal data. Participants included in this group demonstrate the ability to complete mRehab tasks unilaterally.
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Use of mRehab in a Home Program Completing All Activities Bilaterally
n=1 Participants
Participant completed all activities in data collection and in the six week in home mRehab program bilaterally.
|
Total
n=17 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
62.82 years
STANDARD_DEVIATION 13.22 • n=5 Participants
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22 years
n=7 Participants
|
60.32 years
STANDARD_DEVIATION 15.62 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
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Region of Enrollment
United States
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16 participants
n=5 Participants
|
1 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Time to complete activity in the mRehab home program
Vertical bowl transfer
|
5.04 seconds
STANDARD_DEVIATION .91 • n=5 Participants
|
6.63 seconds
n=7 Participants
|
5.13 seconds
STANDARD_DEVIATION .97 • n=5 Participants
|
|
Time to complete activity in the mRehab home program
Horizontal bowl transfer
|
5.03 seconds
STANDARD_DEVIATION 1.32 • n=5 Participants
|
4.87 seconds
n=7 Participants
|
5.02 seconds
STANDARD_DEVIATION 1.28 • n=5 Participants
|
|
Time to complete activity in the mRehab home program
Vertical mug transfer
|
5.22 seconds
STANDARD_DEVIATION 1.22 • n=5 Participants
|
5.39 seconds
n=7 Participants
|
5.23 seconds
STANDARD_DEVIATION 1.09 • n=5 Participants
|
|
Time to complete activity in the mRehab home program
Horizontal mug transfer
|
4.96 seconds
STANDARD_DEVIATION 1.22 • n=5 Participants
|
5.19 seconds
n=7 Participants
|
4.97 seconds
STANDARD_DEVIATION 1.18 • n=5 Participants
|
|
Time to complete activity in the mRehab home program
Simulate sip from mug
|
9.51 seconds
STANDARD_DEVIATION 4.71 • n=5 Participants
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9.38 seconds
n=7 Participants
|
9.50 seconds
STANDARD_DEVIATION 4.64 • n=5 Participants
|
|
Time to complete activity in the mRehab home program
Enter phone number
|
30.86 seconds
STANDARD_DEVIATION 26.28 • n=5 Participants
|
38.22 seconds
n=7 Participants
|
31.29 seconds
STANDARD_DEVIATION 25.50 • n=5 Participants
|
|
Time to complete activity in the mRehab home program
quick tap
|
17.05 seconds
STANDARD_DEVIATION 9.42 • n=5 Participants
|
8.78 seconds
n=7 Participants
|
16.56 seconds
STANDARD_DEVIATION 9.34 • n=5 Participants
|
|
Average smoothness per activity in the mRehab home program
Vertical bowl transfer
|
511.99 jerk score
STANDARD_DEVIATION 297.33 • n=5 Participants
|
1727.74 jerk score
n=7 Participants
|
583.51 jerk score
STANDARD_DEVIATION 412.10 • n=5 Participants
|
|
Average smoothness per activity in the mRehab home program
Horizontal bowl transfer
|
478.53 jerk score
STANDARD_DEVIATION 315.49 • n=5 Participants
|
1015.74 jerk score
n=7 Participants
|
510.13 jerk score
STANDARD_DEVIATION 332.1 • n=5 Participants
|
|
Average smoothness per activity in the mRehab home program
Vertical mug transfer
|
699.24 jerk score
STANDARD_DEVIATION 321.74 • n=5 Participants
|
1254.94 jerk score
n=7 Participants
|
731.93 jerk score
STANDARD_DEVIATION 339.46 • n=5 Participants
|
|
Average smoothness per activity in the mRehab home program
Horizontal mug transfer
|
585.83 jerk score
STANDARD_DEVIATION 233.81 • n=5 Participants
|
485.56 jerk score
n=7 Participants
|
579.93 jerk score
STANDARD_DEVIATION 227.69 • n=5 Participants
|
|
Average smoothness per activity in the mRehab home program
Simulate sip from mug
|
394.17 jerk score
STANDARD_DEVIATION 239.46 • n=5 Participants
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385 jerk score
n=7 Participants
|
393.63 jerk score
STANDARD_DEVIATION 231.86 • n=5 Participants
|
|
Wolf Motor Function Test- Ave time to complete a task over 2 testing sessions using the WMFM
|
17.62 seconds
STANDARD_DEVIATION 22.16 • n=5 Participants
|
96.28 seconds
STANDARD_DEVIATION 0 • n=7 Participants
|
19.90 seconds
STANDARD_DEVIATION 27.96 • n=5 Participants
|
|
Nine hole peg test average time to complete over 2 testing sessions
|
135.52 seconds
STANDARD_DEVIATION 115.91 • n=5 Participants
|
300 seconds
STANDARD_DEVIATION 0 • n=7 Participants
|
144.18 seconds
STANDARD_DEVIATION 118.79 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 week in-home programPopulation: 16 participants with chronic stroke that completed mRehab in-home training with their paretic hand.
The total number of repetitions each participant completed for each activity in mRehab during the 6 week home program was recorded. The average total number of repetitions completed for each activity is reported.
Outcome measures
| Measure |
Use of mRehab in a Home Program
n=16 Participants
mRehab incorporates a task-oriented approach and immediate performance-based feedback. mRehab consists of 3D-printed household items integrated with a smartphone and an app. The app guides participants through practice of activities of daily living. In each session of exercise participants receive feedback on the number of repetitions they complete for each activity, the average time to complete the activity and the average smoothness to perform the activity. Participants were trained in use of mRehab in lab visits and then took mRehab home to use the system. mRehab recorded longitudinal data.
* Participants that met inclusion/exclusion criteria n=19
* Participants that completed baseline data acquisition, training and follow up n=17
* 1 participant withdrew from study prior to home training citing they did not have sufficient time in their schedule to participate.
* 1 participant withdrew during the intervention. Participant felt that their caregiver needed to help with the home program and their schedules did not align well to complete the home program
* Participants included in the analyses n=16
* 1 participant performed mRehab activities hand over hand using assisting the paretic hand. This participant was not considered part of the group that performed all training unilaterally. Their data is not reported.
|
Use of mRehab in a Home Program Completing All Activities Bilaterally
n=1 Participants
Participant completed all activities in data collection and in the six week in-home mRehab program bilaterally.
|
|---|---|---|
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Repetitions Completed for Each Activity in the mRehab Home Program
Vertical bowl transfer
|
282.06 repetitions
Standard Deviation 210.00
|
NA repetitions
Home program data was not obtained from smartphone.
|
|
Repetitions Completed for Each Activity in the mRehab Home Program
Horizontal bowl transfer
|
289.44 repetitions
Standard Deviation 223.34
|
NA repetitions
Home program data was not obtained from smartphone.
|
|
Repetitions Completed for Each Activity in the mRehab Home Program
Vertical mug transfer
|
283.69 repetitions
Standard Deviation 227.94
|
NA repetitions
Home program data was not obtained from smartphone.
|
|
Repetitions Completed for Each Activity in the mRehab Home Program
Horizontal mug transfer
|
292.31 repetitions
Standard Deviation 224.02
|
NA repetitions
Home program data was not obtained from smartphone.
|
|
Repetitions Completed for Each Activity in the mRehab Home Program
Simulate sip from mug
|
202.19 repetitions
Standard Deviation 151.48
|
NA repetitions
Home program data was not obtained from smartphone.
|
|
Repetitions Completed for Each Activity in the mRehab Home Program
Enter phone number
|
153.13 repetitions
Standard Deviation 131.05
|
NA repetitions
Home program data was not obtained from smartphone.
|
|
Repetitions Completed for Each Activity in the mRehab Home Program
Quick tap
|
177.20 repetitions
Standard Deviation 141.26
|
NA repetitions
Home program data was not obtained from smartphone.
|
PRIMARY outcome
Timeframe: last day of the 6 week in home programPopulation: Participants with chronic stroke that completed the mRehab training using their paretic hand.
average time to complete an activity in the mRehab home program
Outcome measures
| Measure |
Use of mRehab in a Home Program
n=16 Participants
mRehab incorporates a task-oriented approach and immediate performance-based feedback. mRehab consists of 3D-printed household items integrated with a smartphone and an app. The app guides participants through practice of activities of daily living. In each session of exercise participants receive feedback on the number of repetitions they complete for each activity, the average time to complete the activity and the average smoothness to perform the activity. Participants were trained in use of mRehab in lab visits and then took mRehab home to use the system. mRehab recorded longitudinal data.
* Participants that met inclusion/exclusion criteria n=19
* Participants that completed baseline data acquisition, training and follow up n=17
* 1 participant withdrew from study prior to home training citing they did not have sufficient time in their schedule to participate.
* 1 participant withdrew during the intervention. Participant felt that their caregiver needed to help with the home program and their schedules did not align well to complete the home program
* Participants included in the analyses n=16
* 1 participant performed mRehab activities hand over hand using assisting the paretic hand. This participant was not considered part of the group that performed all training unilaterally. Their data is not reported.
|
Use of mRehab in a Home Program Completing All Activities Bilaterally
n=1 Participants
Participant completed all activities in data collection and in the six week in-home mRehab program bilaterally.
|
|---|---|---|
|
Time to Complete Activity in the mRehab Home Program
Vertical bowl transfer
|
4.03 seconds
Standard Deviation .46
|
4.17 seconds
|
|
Time to Complete Activity in the mRehab Home Program
Horizontal bowl transfer
|
4.01 seconds
Standard Deviation .60
|
4.71 seconds
|
|
Time to Complete Activity in the mRehab Home Program
Vertical mug transfer
|
5.22 seconds
Standard Deviation 1.22
|
9.28 seconds
|
|
Time to Complete Activity in the mRehab Home Program
Horizontal mug transfer
|
4.00 seconds
Standard Deviation .58
|
4.69 seconds
|
|
Time to Complete Activity in the mRehab Home Program
Simulate sip from mug
|
9.62 seconds
Standard Deviation 1.39
|
9.33 seconds
|
|
Time to Complete Activity in the mRehab Home Program
Enter phone number
|
22.35 seconds
Standard Deviation 14.05
|
25.53 seconds
|
|
Time to Complete Activity in the mRehab Home Program
Quick tap
|
14.75 seconds
Standard Deviation 7.54
|
8.76 seconds
|
PRIMARY outcome
Timeframe: last day of the 6 week in-home programPopulation: 16 participants with chronic stroke performing the in-home rehabilitation unilaterally
The average smoothness per activity in mRehab on the first day of the 6 week home program. Using the acceleration readings from the inertial measurement unit embedded in the smartphone, a normalized jerk score which is dimensionless, allowing comparisons of movements that vary in duration and/or amplitude, can be computed. There are no set upper bounds for the score, as it is dependent on the smoothness. The minimum score is 0, which would indicate no jerk, or perfectly smooth movement. This measurement provides relative information for each movement as a normal range has not been established for each of the movements in this study. Overall, a lower score indicates smoother movement.
Outcome measures
| Measure |
Use of mRehab in a Home Program
n=16 Participants
mRehab incorporates a task-oriented approach and immediate performance-based feedback. mRehab consists of 3D-printed household items integrated with a smartphone and an app. The app guides participants through practice of activities of daily living. In each session of exercise participants receive feedback on the number of repetitions they complete for each activity, the average time to complete the activity and the average smoothness to perform the activity. Participants were trained in use of mRehab in lab visits and then took mRehab home to use the system. mRehab recorded longitudinal data.
* Participants that met inclusion/exclusion criteria n=19
* Participants that completed baseline data acquisition, training and follow up n=17
* 1 participant withdrew from study prior to home training citing they did not have sufficient time in their schedule to participate.
* 1 participant withdrew during the intervention. Participant felt that their caregiver needed to help with the home program and their schedules did not align well to complete the home program
* Participants included in the analyses n=16
* 1 participant performed mRehab activities hand over hand using assisting the paretic hand. This participant was not considered part of the group that performed all training unilaterally. Their data is not reported.
|
Use of mRehab in a Home Program Completing All Activities Bilaterally
n=1 Participants
Participant completed all activities in data collection and in the six week in-home mRehab program bilaterally.
|
|---|---|---|
|
Average Smoothness Per Activity in the mRehab Home Program
Vertical bowl transfer
|
410.66 jerk score
Standard Deviation 128.81
|
768.17 jerk score
|
|
Average Smoothness Per Activity in the mRehab Home Program
Horizontal bowl transfer
|
375.39 jerk score
Standard Deviation 137.23
|
732.16 jerk score
|
|
Average Smoothness Per Activity in the mRehab Home Program
Vertical mug transfer
|
492.70 jerk score
Standard Deviation 226.60
|
1869.6 jerk score
|
|
Average Smoothness Per Activity in the mRehab Home Program
Horizontal mug transfer
|
431.23 jerk score
Standard Deviation 159.97
|
531.8 jerk score
|
|
Average Smoothness Per Activity in the mRehab Home Program
simulating sipping from mug
|
331.11 jerk score
Standard Deviation 61.77
|
347.17 jerk score
|
SECONDARY outcome
Timeframe: within 1 week of the completion of the in-home programPopulation: Participants with chronic stroke that performed mRehab activities unilaterally.
The Wolf Motor Function Test (WMFT) is used to assess function of the upper extremity. The 17 item version of the WMFT was used. Tasks in the WMFT include tasks that assess gross motor activity (such as lifting hand/arm and placing it on a box), fine motor activity (such as picking up a paper clip) and strength. One timed task is a bilateral task (folding a towel). For timed tasks, participants are given up to 120 seconds to complete the task. If they cannot successfully complete it in that time they are given the max score of 120 seconds. In our papers we only use the timed tasks in the WMFT in our analyses. We report the average time to complete a task in the WMFT. A lower score indicates less time is required to complete the task.
Outcome measures
| Measure |
Use of mRehab in a Home Program
n=16 Participants
mRehab incorporates a task-oriented approach and immediate performance-based feedback. mRehab consists of 3D-printed household items integrated with a smartphone and an app. The app guides participants through practice of activities of daily living. In each session of exercise participants receive feedback on the number of repetitions they complete for each activity, the average time to complete the activity and the average smoothness to perform the activity. Participants were trained in use of mRehab in lab visits and then took mRehab home to use the system. mRehab recorded longitudinal data.
* Participants that met inclusion/exclusion criteria n=19
* Participants that completed baseline data acquisition, training and follow up n=17
* 1 participant withdrew from study prior to home training citing they did not have sufficient time in their schedule to participate.
* 1 participant withdrew during the intervention. Participant felt that their caregiver needed to help with the home program and their schedules did not align well to complete the home program
* Participants included in the analyses n=16
* 1 participant performed mRehab activities hand over hand using assisting the paretic hand. This participant was not considered part of the group that performed all training unilaterally. Their data is not reported.
|
Use of mRehab in a Home Program Completing All Activities Bilaterally
n=1 Participants
Participant completed all activities in data collection and in the six week in-home mRehab program bilaterally.
|
|---|---|---|
|
Wolf Motor Function Test
|
15.25 seconds
Standard Deviation 21.31
|
96.27 seconds
|
SECONDARY outcome
Timeframe: within 1 week of the end of the in-home programPopulation: Participants with stroke that participated in a home rehabilitation program using mRehab.
A timed clinical assessment used to measure finger dexterity. Lower times represent better performance. Participants place 9 pegs in 9 holes and then remove the pegs and place them in a container. The stop watch starts when the participant touches the first peg and stops when they place the last peg in the container. If participants could not complete placing the pegs in the holes they were given a score of 300 seconds.
Outcome measures
| Measure |
Use of mRehab in a Home Program
n=16 Participants
mRehab incorporates a task-oriented approach and immediate performance-based feedback. mRehab consists of 3D-printed household items integrated with a smartphone and an app. The app guides participants through practice of activities of daily living. In each session of exercise participants receive feedback on the number of repetitions they complete for each activity, the average time to complete the activity and the average smoothness to perform the activity. Participants were trained in use of mRehab in lab visits and then took mRehab home to use the system. mRehab recorded longitudinal data.
* Participants that met inclusion/exclusion criteria n=19
* Participants that completed baseline data acquisition, training and follow up n=17
* 1 participant withdrew from study prior to home training citing they did not have sufficient time in their schedule to participate.
* 1 participant withdrew during the intervention. Participant felt that their caregiver needed to help with the home program and their schedules did not align well to complete the home program
* Participants included in the analyses n=16
* 1 participant performed mRehab activities hand over hand using assisting the paretic hand. This participant was not considered part of the group that performed all training unilaterally. Their data is not reported.
|
Use of mRehab in a Home Program Completing All Activities Bilaterally
n=1 Participants
Participant completed all activities in data collection and in the six week in-home mRehab program bilaterally.
|
|---|---|---|
|
Nine Hole Peg Test
|
136.36 seconds
Standard Deviation 108.96
|
300 seconds
|
SECONDARY outcome
Timeframe: within 1 - 3 weeks of the end of the programPopulation: Participants with stroke that participated in a 6 week home program using mRehab.
A scale used to elicit user opinions on ease of use of the 3D printed objects (mug, bowl, key, and doorknob). It was a 7 point likert scale ranging from Very Difficult to Very Easy. The range was -3 to 3. A score of -3 represented the three-dimensional printed object was very difficult to use and a score of 3 representing the object was easy to use. The scores for the mug, bowl, key and door knob are included in the mean score given below.
Outcome measures
| Measure |
Use of mRehab in a Home Program
n=12 Participants
mRehab incorporates a task-oriented approach and immediate performance-based feedback. mRehab consists of 3D-printed household items integrated with a smartphone and an app. The app guides participants through practice of activities of daily living. In each session of exercise participants receive feedback on the number of repetitions they complete for each activity, the average time to complete the activity and the average smoothness to perform the activity. Participants were trained in use of mRehab in lab visits and then took mRehab home to use the system. mRehab recorded longitudinal data.
* Participants that met inclusion/exclusion criteria n=19
* Participants that completed baseline data acquisition, training and follow up n=17
* 1 participant withdrew from study prior to home training citing they did not have sufficient time in their schedule to participate.
* 1 participant withdrew during the intervention. Participant felt that their caregiver needed to help with the home program and their schedules did not align well to complete the home program
* Participants included in the analyses n=16
* 1 participant performed mRehab activities hand over hand using assisting the paretic hand. This participant was not considered part of the group that performed all training unilaterally. Their data is not reported.
|
Use of mRehab in a Home Program Completing All Activities Bilaterally
Participant completed all activities in data collection and in the six week in-home mRehab program bilaterally.
|
|---|---|---|
|
Difficulty Rating Scale
|
1.07 units on a scale
Standard Deviation 1.07
|
—
|
SECONDARY outcome
Timeframe: within 1-3 weeks of completion of home programPopulation: Participants with stroke that completed a 6 week home program using mRehab.
A reliable tool for measuring usability. The Systems Usability Scale (SUS) consists of 10 questions, each rated on a 5-point Likert scale ranging from Strongly agree to Strongly disagree. The SUS was used to assess the participant's satisfaction with the mRehab system. A higher score represents a more positive perception of the device. A score of 50 would represent the strongest agreement that mRehab is a usable system. A score of 10 would represent the strongest disagreement that mRehab is a usable system.
Outcome measures
| Measure |
Use of mRehab in a Home Program
n=16 Participants
mRehab incorporates a task-oriented approach and immediate performance-based feedback. mRehab consists of 3D-printed household items integrated with a smartphone and an app. The app guides participants through practice of activities of daily living. In each session of exercise participants receive feedback on the number of repetitions they complete for each activity, the average time to complete the activity and the average smoothness to perform the activity. Participants were trained in use of mRehab in lab visits and then took mRehab home to use the system. mRehab recorded longitudinal data.
* Participants that met inclusion/exclusion criteria n=19
* Participants that completed baseline data acquisition, training and follow up n=17
* 1 participant withdrew from study prior to home training citing they did not have sufficient time in their schedule to participate.
* 1 participant withdrew during the intervention. Participant felt that their caregiver needed to help with the home program and their schedules did not align well to complete the home program
* Participants included in the analyses n=16
* 1 participant performed mRehab activities hand over hand using assisting the paretic hand. This participant was not considered part of the group that performed all training unilaterally. Their data is not reported.
|
Use of mRehab in a Home Program Completing All Activities Bilaterally
Participant completed all activities in data collection and in the six week in-home mRehab program bilaterally.
|
|---|---|---|
|
Systems Usability Scale (SUS)
|
31.25 units on a scale
Standard Deviation 3.80
|
—
|
SECONDARY outcome
Timeframe: within 1-3 weeks of completion of the 6 week in-home programPopulation: Participants with stroke that used mRehab in a 6 week home program.
The mRehab (mobile Rehab) acceptance questionnaire was designed to assess the participants perception of the mRehab system we designed for this study. The questionnaire is based upon the Technology Acceptance model using a seven-point Likert scale - highly disagree (1) to highly agree (7)- for each question. Participants responded to 16 questions that probed the user's perceception of how they interacted with technology (3 questions) and their perceived usefulness, perceived ease of use, and behavioral intention to use the mRehab system in the future (13 questions). The total score is calculated as the sum of the response to each question. A score demonstrating the participant highly agreed that they would interact with technology and that they found mRehab useful, easy to use and that they would use in in the future would be 112. The minimum total score would be 16 (with a rating of highly disagree for each question). Higher scores would indicate better acceptance/interaction.
Outcome measures
| Measure |
Use of mRehab in a Home Program
n=16 Participants
mRehab incorporates a task-oriented approach and immediate performance-based feedback. mRehab consists of 3D-printed household items integrated with a smartphone and an app. The app guides participants through practice of activities of daily living. In each session of exercise participants receive feedback on the number of repetitions they complete for each activity, the average time to complete the activity and the average smoothness to perform the activity. Participants were trained in use of mRehab in lab visits and then took mRehab home to use the system. mRehab recorded longitudinal data.
* Participants that met inclusion/exclusion criteria n=19
* Participants that completed baseline data acquisition, training and follow up n=17
* 1 participant withdrew from study prior to home training citing they did not have sufficient time in their schedule to participate.
* 1 participant withdrew during the intervention. Participant felt that their caregiver needed to help with the home program and their schedules did not align well to complete the home program
* Participants included in the analyses n=16
* 1 participant performed mRehab activities hand over hand using assisting the paretic hand. This participant was not considered part of the group that performed all training unilaterally. Their data is not reported.
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Use of mRehab in a Home Program Completing All Activities Bilaterally
n=1 Participants
Participant completed all activities in data collection and in the six week in-home mRehab program bilaterally.
|
|---|---|---|
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mRehab Acceptance Questionnaire
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91.56 units on a scale
Standard Deviation 11.79
|
106 units on a scale
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Adverse Events
Use of mRehab in a Home Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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