Skip to content

Impact of Custom Assistive and Adaptive Technology in Rehabilitation

Evaluating the Impact of Custom Assistive and Adaptive Technology

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03567239
Enrollment
5
Registered
2018-06-25
Start date
2018-06-25
Completion date
2020-02-26
Last updated
2024-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Rehabilitation Engineering, Adaptive Devices, Assistive 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.

Interventions

DEVICEUsing 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.

Sponsors

Madonna Rehabilitation Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

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.

Intervention model description

Participants receive adaptive device and provide feedback.

Eligibility

Sex/Gender
ALL
Age
1 Years to 85 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
The PIADS (Psychosocial Impact of Assistive Devices) Mean Score2-30 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

MeasureTime frameDescription
Workload2-30 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 Scores2-30 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Using Adaptive Device
Participants will use a non-commercially available device, designed to meet their needs. 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.
5
Total5

Baseline characteristics

CharacteristicUsing Adaptive Device
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
5 Participants
Age, Continuous35 years
Race and Ethnicity Not Collected— Participants
Region of Enrollment
United States
5 participants
Sex: Female, Male
Female
1 Participants
Sex: Female, Male
Male
4 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 5
other
Total, other adverse events
0 / 5
serious
Total, serious adverse events
0 / 5

Outcome results

Primary

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.

Time frame: 2-30 days after receiving device.

ArmMeasureGroupValue (MEAN)
Received Intervention TechnologyThe PIADS (Psychosocial Impact of Assistive Devices) Mean ScoreCompetence2.58 score on a scale
Received Intervention TechnologyThe PIADS (Psychosocial Impact of Assistive Devices) Mean ScoreAdaptability2.07 score on a scale
Received Intervention TechnologyThe PIADS (Psychosocial Impact of Assistive Devices) Mean ScoreSelf-Esteem2.05 score on a scale
Received Intervention TechnologyThe PIADS (Psychosocial Impact of Assistive Devices) Mean ScoreLikert6.8 score on a scale
Secondary

QUEST Questionnaire Form Scores

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.

Time frame: 2-30 days after receiving device.

ArmMeasureGroupValue (MEAN)
Received Intervention TechnologyQUEST Questionnaire Form ScoresOverall4.27 score on a scale
Received Intervention TechnologyQUEST Questionnaire Form ScoresDevice4.33 score on a scale
Received Intervention TechnologyQUEST Questionnaire Form ScoresServices4.15 score on a scale
Comparison: The QUEST (Quebec User Evaluation of Satisfaction with Assistive Technology) evaluates a patient's satisfaction with various assistive technologies. It has two subgroups, Device and Service on a scale of 1-5 with 5 being the best score.
Secondary

Workload

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.

Time frame: 2-30 days after receiving device.

ArmMeasureGroupValue (MEAN)
Received Intervention TechnologyWorkloadOverall5.80 score on a scale
Received Intervention TechnologyWorkloadMental Demand10.2 score on a scale
Received Intervention TechnologyWorkloadPhysical Demand4.6 score on a scale
Received Intervention TechnologyWorkloadTemporal Demand7.6 score on a scale
Received Intervention TechnologyWorkloadPerformance4 score on a scale
Received Intervention TechnologyWorkloadEffort4.2 score on a scale
Received Intervention TechnologyWorkloadFrustration4.2 score on a scale
Comparison: The NASA Task Load Index ranges from 1 to 21 with the lower the score the better.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026