Impact of Custom Assistive and Adaptive Technology in Rehabilitation

NCT03567239 | Completed Results

• 1 other identifier: 17-009-FB
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Disability Physical; Brain Injuries; Stroke; Spinal Cord Injuries; Multiple Sclerosis; Paralysis

Keywords

Rehabilitation Engineering; Adaptive Devices; Assistive Technology

Outcome Measures

Primary Outcomes (1)

• The PIADS (Psychosocial Impact of Assistive Devices) Mean Score

  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.

  2-30 days after receiving device.

Secondary Outcomes (2)

• Workload

  2-30 days after receiving device.

• QUEST Questionnaire Form Scores

  2-30 days after receiving device.

Study Arms (1)

Using adaptive device

EXPERIMENTAL

Participants will use a non-commercially available device, designed to meet their needs.

Device: Using adaptive device.

Interventions

Using adaptive device. 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.

Using adaptive device

Eligibility Criteria

• Age: 1 Year - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None.

Sponsors & Collaborators

• Madonna Rehabilitation Hospital: lead

Study Sites (1)

Madonna Rehabilitation Hospitals

Lincoln, Nebraska, 68506, United States

Location

Related Publications (10)

• Brod M, Tesler LE, Christensen TL. Qualitative research and content validity: developing best practices based on science and experience. Qual Life Res. 2009 Nov;18(9):1263-78. doi: 10.1007/s11136-009-9540-9. Epub 2009 Sep 27.

  PMID: 19784865 BACKGROUND

• Cook, A. M., & Gray, D. B. (2017, May 12). Assistive Technology. Retrieved July 10, 2017, from Encyclopædia Britannica website: http://www.britannica.com/topic/assistive-technology

  BACKGROUND

• Day, H., & Jutai, J. (1996). Measuring the Psychosocial Impact of Assistive Devices: the PIADS*. Canadian Journal of Rehabilitation, 9(2), 159-168.

  BACKGROUND

• Day H, Jutai J, Campbell KA. Development of a scale to measure the psychosocial impact of assistive devices: lessons learned and the road ahead. Disabil Rehabil. 2002 Jan 10-Feb 15;24(1-3):31-7. doi: 10.1080/09638280110066343.

  PMID: 11827152 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Jutai, J., & Day, H. (2002). The assessment of assistive technology outcomes, effects and costs. Technology and Disability, 14(3), 107-111.

  BACKGROUND

• United States, Congress, House. Assistive Technology Act. Government Printing Office, 2004. 108th Congress, House Document publ364.108

  BACKGROUND

• World Health Organization. (2001). International Classification of Functioning, Disability and Health: ICF. World Health Organization

  BACKGROUND

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

  RESULT

MeSH Terms

Conditions

Brain Injuries; Stroke; Spinal Cord Injuries; Multiple Sclerosis; Paralysis

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Spinal Cord Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Chase Pfeifer, Ph.D.
• Organization: Madonna Rehabilitation Hospital

cpfeifer@madonna.org

402-413-4504

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst Research Dir, Rehabilitation Engineering Center

Model Details: Participants receive adaptive device and provide feedback.

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 25, 2018
• Study Start: June 25, 2018
• Primary Completion: September 1, 2019
• Study Completion: February 26, 2020
• Last Updated: November 25, 2024
• Results First Posted: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)