Trial Outcomes & Findings for Impact of Custom Assistive and Adaptive Technology in Rehabilitation (NCT NCT03567239)
NCT ID: NCT03567239
Last Updated: 2024-11-25
Results Overview
The PIADS (Psychosocial Impact of Assistive Devices) questionnaire will be completed by each participant giving feedback on how use of the device impacts 26 different aspects of their life. These 26 questions are answered on a scale of -3 to 3 and are broken into three subscales (Competence, Adaptability, and Self-Esteem). Depending on the question 3 may be most positive, or -3 may be most positive. Through how the PIADS responses are added together, subscales result in a range of -3 to 3 with 3 being the most positive. Details on this questionnaire and how the results are calculated can be found here: https://piads.at/ Each participant will also identify the specific need the device addresses and will rate on a 7-point Likert scale how effective the adaptive device is at addressing that need. This ranged from 1-7 with 7 being the most positive.
COMPLETED
NA
5 participants
2-30 days after receiving device.
2024-11-25
Participant Flow
Participant milestones
| Measure |
Using Adaptive Device
Participants will use a non-commercially available device, designed to meet their needs.
Using adaptive device.: Participant uses the specially designed device for a specified length of time (no less than two days) and feedback is then gathered from the participant through questionnaires. These questionnaires include NASA-TLX, PIADS, QUEST, and a single question asking if the device improved their ability to address their specific need.
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|---|---|
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Overall Study
STARTED
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5
|
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Overall Study
COMPLETED
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5
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Using Adaptive Device
n=5 Participants
Participants will use a non-commercially available device, designed to meet their needs.
Using adaptive device.: Participant uses the specially designed device for a specified length of time (no less than two days) and feedback is then gathered from the participant through questionnaires. These questionnaires include NASA-TLX, PIADS, QUEST, and a single question asking if the device improved their ability to address their specific need.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
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Age, Continuous
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35 years
n=5 Participants
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|
Sex: Female, Male
Female
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1 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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4 Participants
n=5 Participants
|
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Region of Enrollment
United States
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5 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 2-30 days after receiving device.The PIADS (Psychosocial Impact of Assistive Devices) questionnaire will be completed by each participant giving feedback on how use of the device impacts 26 different aspects of their life. These 26 questions are answered on a scale of -3 to 3 and are broken into three subscales (Competence, Adaptability, and Self-Esteem). Depending on the question 3 may be most positive, or -3 may be most positive. Through how the PIADS responses are added together, subscales result in a range of -3 to 3 with 3 being the most positive. Details on this questionnaire and how the results are calculated can be found here: https://piads.at/ Each participant will also identify the specific need the device addresses and will rate on a 7-point Likert scale how effective the adaptive device is at addressing that need. This ranged from 1-7 with 7 being the most positive.
Outcome measures
| Measure |
Received Intervention Technology
n=5 Participants
Individuals who received a device.
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|---|---|
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The PIADS (Psychosocial Impact of Assistive Devices) Mean Score
Competence
|
2.58 score on a scale
Interval 2.0 to 2.92
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The PIADS (Psychosocial Impact of Assistive Devices) Mean Score
Adaptability
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2.07 score on a scale
Interval 1.75 to 3.0
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The PIADS (Psychosocial Impact of Assistive Devices) Mean Score
Self-Esteem
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2.05 score on a scale
Interval 1.75 to 2.62
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The PIADS (Psychosocial Impact of Assistive Devices) Mean Score
Likert
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6.8 score on a scale
Interval 6.0 to 7.0
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SECONDARY outcome
Timeframe: 2-30 days after receiving device.The National Aeronautics and Space Administration - Task Load Index (NASA-TLX) questionnaire will be completed by each participant giving feedback on how demanding the device is mentally, physically, etc. There are six subscales withing the NASA-TLX - Mental Demand, Physical Demand, Temporal Demand, Performance, Effort, and Frustration. Each subscale has 21 gradations with 1 being the best and 21 being the worst. The overall index for each participant was an average of their six subscales.
Outcome measures
| Measure |
Received Intervention Technology
n=5 Participants
Individuals who received a device.
|
|---|---|
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Workload
Overall
|
5.80 score on a scale
Interval 4.17 to 8.83
|
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Workload
Mental Demand
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10.2 score on a scale
Interval 5.0 to 18.0
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Workload
Physical Demand
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4.6 score on a scale
Interval 1.0 to 11.0
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Workload
Temporal Demand
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7.6 score on a scale
Interval 3.0 to 16.0
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Workload
Performance
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4 score on a scale
Interval 1.0 to 11.0
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Workload
Effort
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4.2 score on a scale
Interval 1.0 to 11.0
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Workload
Frustration
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4.2 score on a scale
Interval 2.0 to 5.0
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SECONDARY outcome
Timeframe: 2-30 days after receiving device.The Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) questionnaire will be completed by each participant giving feedback on how satisfied they are with the device and the related services they experienced. This questionnaire included a total of 12 questions, each question was answered on a scale of 1-5 with 1=Not satisfied at all, 5=Very satisfied. The higher the score the better the outcome. Eight of these questions were related to the Device subscale. Four were related to the Services subscale. An Overall score was given taking the average response from ALL 12 questions for each participant. A higher the number on the 1-5 scale indicates a better outcome.
Outcome measures
| Measure |
Received Intervention Technology
n=5 Participants
Individuals who received a device.
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|---|---|
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QUEST Questionnaire Form Scores
Overall
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4.27 score on a scale
Interval 3.83 to 4.75
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QUEST Questionnaire Form Scores
Device
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4.33 score on a scale
Interval 4.0 to 4.63
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QUEST Questionnaire Form Scores
Services
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4.15 score on a scale
Interval 3.25 to 5.0
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Adverse Events
Using Adaptive Device
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