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Impact of Custom Assistive and Adaptive Technology in Rehabilitation

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

Tracking Information
First Submitted Date  ICMJE May 23, 2018
First Posted Date  ICMJE June 25, 2018
Last Update Posted Date May 3, 2019
Actual Study Start Date  ICMJE June 25, 2018
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03567239 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2018)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Custom Assistive and Adaptive Technology in Rehabilitation
Official Title  ICMJE Evaluating the Impact of Custom Assistive and Adaptive Technology
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.
Detailed Description

Rehabilitation engineering is a relatively new field that encompasses many diverse disciplines in engineering, technology, and medicine. Many hospitals do not have a rehabilitation engineering department and their patients are limited to products that are commercially available. These products are often very expensive and not ideal for the user.

Each individual has unique needs. The REC at Madonna Rehabilitation Hospitals (MRH), as well as other RECs around the world, are focused on efficiently developing novel devices for specific patient needs and creating robust modifications to existing technologies to redirect something designed for the "average" person into something that is customized to the individual.

At Madonna this service is important for individuals with disabilities. Thus, the purpose of this work is to seek input/feedback from end-users regarding the impact of the adaptive device on their function, independence, and quality of life. The investigators expect that the feedback received may guide future design integrations and will document the impact of such services on individuals with disabilities and their caregivers and clinicians. The main goal is that this feedback will demonstrate how a REC, such as the one at MRH, impacts patients' lives and therefore improves patients' outcomes. Enhanced patient outcome measures are valued by all hospitals, and therefore may encourage other hospitals to establish a REC. Additionally, feedback recorded from participants could be integrated into presentations and publications aimed at knowledge dissemination to communities of interest.

Per current REC and MRH procedures, each patient will utilize a device designed or adapted by a rehabilitation engineer within the REC with input from both patient and clinician, along with other relevant experts. These adaptive devices are expected to vary widely and may include items such as toileting tools (for bowel and bladder control), assistive transfer devices, and electronic devices for environmental control.

Individuals in MRH's inpatient and outpatient programs provide care for individuals with a diverse range and level of disabilities. Approximately 2-3 patients each week receive a custom built assistive device to increase their independence and/or hasten their recovery.

A MRH research staff member will meet with the potential participant after the patient has received the requested REC assistive or adaptive device and have indicated to their therapist that they would like to learn more about the study. The participant and a legal guardian (if appropriate) will be asked to fill out the informed consent/assent, Authorization to Disclose Health Information (to assist in understanding the participant's diagnosis and other potential health problems), and photo/video consent.

Information about relevant functional activities (e.g. feeding, transfers, ambulation) are quantified using functional independence and assessment measures (FIM/FAM scores) while the participant is at MRH. FIM(Functional Independence Measure)/FAM(Functional Assessment Measure) scores may be requested from the participant's primary therapist (if the participant allows via the Authorization to Disclose Health Information) for areas that would be influenced by the use of the assistive or adaptive device (e.g., if a device is built to assist a patient in transferring, scores in relation to the Car transfer category may be requested). These scores may be requested for the most recent date prior to receiving the device, when the patient discharges, and periodically throughout their time at Madonna (e.g., daily scores may be requested to help determine the learning curve required to utilize the device).

As part of this study, the participant will meet with a member of the MRH research staff again after using the assistive device for at least 2 days (maximum of 30 days). As appropriate, individuals utilizing the assistive devices (or their designated respondent if unable to personally respond) will also be asked to complete one or more qualitative and quantitative questionnaires to help understand the impact of the adaptive device on their function, independence, and quality of life. Then each participant will be asked to identify the specific need the device addresses and will rate on a 7-point Likert scale how effective the adaptive device is at addressing the specific need. The clinician or a caregiver may also be asked to complete one or more of the questionnaires while thinking about how the assistive device affects their patient/loved one. Qualitative comments and ratings will be collected on the perceived potential value, ease of use, acceptability, and preference for the device.

Individual patient outcomes will be evaluated as well as similar devices that are utilized for different patients and diagnosis will be compared. Data will also be evaluated with regard to diagnosis and type of assistive device (i.e., toileting, transfer, technology access, etc.) to help understand what types of devices certain populations are lacking. Quantitative data will be analyzed through descriptive, parametric, and nonparametric statistics, as appropriate.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Disability Physical
  • Brain Injuries
  • Stroke
  • Spinal Cord Injuries
  • Multiple Sclerosis
  • Paralysis
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Using adaptive device
Participants will use a non-commercially available device, designed to meet their needs.
Intervention: Device: Using adaptive device.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 12, 2018)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • None.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chase Pfeifer, Ph.D. 402-413-4516 cpfeifer@madonna.org
Contact: Judith M. Burnfield, Ph.D. 402-413-4505 jburnfield@madonna.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03567239
Other Study ID Numbers  ICMJE 17-009-FB
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chase Pfeifer, Madonna Rehabilitation Hospital
Study Sponsor  ICMJE Madonna Rehabilitation Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Madonna Rehabilitation Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP