Impact of Custom Assistive and Adaptive Technology in Rehabilitation

Not Applicable

Completed

Conditions: Disability Physical
Multiple Sclerosis
Stroke
Paralysis
Brain Injuries
Spinal Cord Injuries

Interventions: Device: Using adaptive device.

Registration Number: NCT03567239

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 5

Inclusion Criteria

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

Exclusion Criteria

None.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Using adaptive device	Using adaptive device.	Participants will use a non-commercially available device, designed to meet their needs.

Primary Outcome Measures

Name	Time	Method
The PIADS (Psychosocial Impact of Assistive Devices) Mean Score	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.

Secondary Outcome Measures

Name	Time	Method
Workload	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.
QUEST Questionnaire Form Scores	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.