Impact of Custom Assistive and Adaptive Technology in Rehabilitation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03567239|
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : May 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Disability Physical Brain Injuries Stroke Spinal Cord Injuries Multiple Sclerosis Paralysis||Device: Using adaptive device.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Participants receive adaptive device and provide feedback.|
|Masking:||None (Open Label)|
|Masking Description:||Participants provide feedback of adaptive device they are provided. They, their caregiver, the investigator, and research staff are aware of all phases of the study.|
|Primary Purpose:||Supportive Care|
|Official Title:||Evaluating the Impact of Custom Assistive and Adaptive Technology|
|Actual Study Start Date :||June 25, 2018|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2021|
Experimental: Using adaptive device
Participants will use a non-commercially available device, designed to meet their needs.
Device: 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.
- Quality of Life [ Time Frame: 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. 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.
- Workload [ Time Frame: 2-30 days after receiving device. ]The NASA-TLX (National Aeronautics and Space Administration - Task Load Index ) questionnaire will be completed by each participant giving feedback on how demanding the device is mentally, physically, etc.
- Satisfaction [ Time Frame: 2-30 days after receiving device. ]The QUEST questionnaire will be completed by each participant giving feedback on how satisfied they are with the device and the related services they experienced.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567239
|Contact: Chase Pfeifer, Ph.D.||email@example.com|
|Contact: Judith M. Burnfield, Ph.D.||firstname.lastname@example.org|
|United States, Nebraska|
|Madonna Rehabilitation Hospitals||Recruiting|
|Lincoln, Nebraska, United States, 68506|
|Contact: Chase M Pfeifer, PhD 402-413-4516 email@example.com|