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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. Identifier: NCT03567239
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : May 3, 2019
Information provided by (Responsible Party):
Chase Pfeifer, Madonna Rehabilitation Hospital

Brief Summary:
Madonna's Rehabilitation Engineering Center of Excellence (REC) is continually developing custom devices for persons with disabilities. These devices are created to improve the independence of individuals living with disabilities at Madonna Rehabilitation Hospitals and in the community. The purpose of this study is to investigate the impact custom assistive and adaptive devices have on patient independence, quality of life, and experience at Madonna Rehabilitation Hospitals.

Condition or disease Intervention/treatment Phase
Disability Physical Brain Injuries Stroke Spinal Cord Injuries Multiple Sclerosis Paralysis Device: Using adaptive device. Not Applicable

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Madonna Inpatient or Outpatient
  • Disability
  • Have need requiring assistive device or adaptation to device not currently on commercial market

Exclusion Criteria:

  • None.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03567239

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Contact: Chase Pfeifer, Ph.D. 402-413-4516
Contact: Judith M. Burnfield, Ph.D. 402-413-4505

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United States, Nebraska
Madonna Rehabilitation Hospitals Recruiting
Lincoln, Nebraska, United States, 68506
Contact: Chase M Pfeifer, PhD    402-413-4516   
Sponsors and Collaborators
Madonna Rehabilitation Hospital

Publications of Results:
Brault, M. W. (2012). Americans with disabilities: 2010 (pp. 1-23). Washington, DC: US Department of Commerce, Economics and Statistics Administration, US Census Bureau.

Other Publications:
Cook, A. M., & Gray, D. B. (2017, May 12). Assistive Technology. Retrieved July 10, 2017, from Encyclopædia Britannica website:
Day, H., & Jutai, J. (1996). Measuring the Psychosocial Impact of Assistive Devices: the PIADS*. Canadian Journal of Rehabilitation, 9(2), 159-168.
Demers, L., Weiss-Lambrou, R., & Ska, B. (2002). The Quebec user evaluation of satisfaction with assistive technology (QUEST 2.0): An overview and recent progress. Technology and Disability, 14, 101-105.
Hart, S. G., & Staveland, L. E. (1988). Development of NASA-TLX (Task Load Index): Results of empirical and theoretical research. Advances in psychology, 52, 139-183.
Jutai, J., & Day, H. (2002). The assessment of assistive technology outcomes, effects and costs. Technology and Disability, 14(3), 107-111.
United States, Congress, House. Assistive Technology Act. Government Printing Office, 2004. 108th Congress, House Document publ364.108
World Health Organization. (2001). International Classification of Functioning, Disability and Health: ICF. World Health Organization

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Responsible Party: Chase Pfeifer, Asst Research Dir, Rehabilitation Engineering Center, Madonna Rehabilitation Hospital Identifier: NCT03567239    
Other Study ID Numbers: 17-009-FB
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chase Pfeifer, Madonna Rehabilitation Hospital:
Rehabilitation Engineering
Adaptive Devices
Assistive Technology
Additional relevant MeSH terms:
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Multiple Sclerosis
Brain Injuries
Spinal Cord Injuries
Wounds and Injuries
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Spinal Cord Diseases
Neurologic Manifestations
Signs and Symptoms