Adaptive and Individualized AAC
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Natick, Massachusetts, United States, 01760
- Altec Inc.
-
-
Nebraska
-
Lincoln, Nebraska, United States, 68506
- Madonna Rehabilitation Hospital Institute for Rehabilitation Science and Engineering
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Control Subjects:
- Adults and Children; >12yo
- Male or Female
- All participants will be: (a) able to spell, (b) able to follow 2-3 step directions, (c) have functional vision sufficient to read 40 point text
- No history of communication disorders;
- No history of neurological disorders affecting speech or head movement.
Subjects with SPI:
- Adults or Children; age>12yo
- Male or Female
- All participants will be: (a) able to spell, (b) able to follow 2-3 step directions, (c) have functional vision sufficient to read 40 point text, and (d) have a motor impairment that requires the use of an alternative access strategy to communicate and/or use technology.
- Current or prospective AAC user with complex communication needs representing a broad spectrum of developmental and acquired SPI disabilities resulting from high spinal cord injury, chronic Guillain-Barré syndrome, brain stem stroke, cerebral palsy, locked-in syndrome, among others;
- Sufficient head control and voluntary facial muscle activation (on the basis of clinical evaluation by Dr. Susan Fager and her team) to use the proposed wearable EMG/IMU sensor for the purposes of this study;
- Evidence of at least partial voluntary head movement in at least 2 degrees of freedom (Individual differences in providing controlled movements of the head in various degrees of freedom due to their disease or trauma is not only acceptable but desirable);
- Sufficient stamina and developmental maturity (on the basis of clinical evaluation by Dr. Susan Fager) to attend to the approximately 1-hour protocol outlined in Aims 1 and 3 without excess fatigue or distraction;
- Availability for at least 3-4 testing sessions over the study period;
- No medical or safety restrictions of active head and neck movement (as determined by Dr. Susan Fager in consultation with her clinical team);
- Clinical evidence of preserved cognition by a score of 0 or 1 on NIHSS Consciousness and Communication item;
- Ability to voluntarily blink eyes or raise eyebrows on command.
Exclusion Criteria:
Control Subjects
- Non-English speaker;
- Inability to follow simple instructions in English;
- Restricted ROM of the head or neck;
- Pain with head movement
- Medical history of cardiac or respiratory complications, or disorders that would place the subject at risk for conducting the different motor activities;
- Skin disorders that result in open lesions or hyper-sensitive/fragile skin on the forehead, preventing the use of medical-grade adhesive tapes to secure the sensors to the skin;
- Unable to provide informed consent in English.
Subjects with SPI
- Non-English speaker;
- Inability to follow simple instructions in English;
- Medical history of musculoskeletal conditions (arthritis, spondylosis, etc.) that severely limit head movement or causes pain on head movement;
- Restricted active or passive rotation of head and neck resulting from unstable vertebral, spinal cord, or nerve roots that places the subject at risk;
- Medical history of cardiac or respiratory complications, or similar disorders that would severely reduce stamina and/or place the subject at risk for conducting the different motor activities;
- Skin disorders that result in open lesions or hyper-sensitive/fragile skin on the forehead, preventing the use of medical-grade adhesive tapes to secure the sensors to the skin;
- Unable to provide informed consent in English.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Experimental and Generic Communication Interfaces for AAC
Receives both Experimental and Generic AAC systems to communicate.
Each participant will receive both devices, with Experimental AAC presented first (Day 1) and Generic AAC presented second (Day 2; reference).
|
Participant receives an AAC system comprising a single hybrid wearable sensor for head-mediated cursor control that is integrated with an adaptive and individualized keyboard to test communication performance.
Participant receives an AAC system comprising a single hybrid wearable sensor for head-mediated cursor control that is integrated with a generic QWERTY keyboard to test communication performance.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Movement Time
Time Frame: 1 Day
|
Time needed to navigate a cursor to and select a target on a computer screen by control of head movement and facial muscle contractions for each AAC device, wherein lower movement times equate to better performance.
|
1 Day
|
|
Path-to-Target Movement Variability
Time Frame: 1 Day
|
Path smoothness relative to the optimal, straight path between targets on a computer screen by control of head movement and facial muscle contractions for each AAC device.
Variability is estimated as a distance of pixels as estimated from a computer screen operating with a resolution of 1920 pixels x 1080 pixels, wherein smaller variability scores equate to better performance.
|
1 Day
|
|
Target Selection Accuracy
Time Frame: 1 Day
|
Percentage of accurate selections of targets on a computer screen by control of head movement and facial muscle contractions for each AAC device, wherein higher accuracy scores equate to better performance.
|
1 Day
|
|
Information Transfer Rate
Time Frame: 1 Day
|
Human motor performance relative to the speed and accuracy of cursor-to-target movements on a computer screen by control of head movement and facial muscle contractions for each AAC device, wherein higher information transfer rates equate to better performance.
|
1 Day
|
|
AAC Device Usability
Time Frame: 1 Day
|
Self-report of perceived AAC device usability as captured via a Likert scale anchored from 1 ("very difficult") to 7 ("very easy"), wherein higher usability scores equate to better performance.
|
1 Day
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Paola Contessa, PhD, Altec Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- AAC Phase I
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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