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N/A N=30 Other

Adaptive and Individualized AAC

Communication Disorders

Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Movement Time — 2.5; 2.9 Seconds

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Experimental AAC (Device); Generic AAC (Device)
Age
Pediatric, Adult, Older Adult · 12+ yrs
Sex
All
Sponsor
Altec Inc.
Primary completion
Aug 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Movement Time
2.5; 2.9
PRIMARY
Path-to-Target Movement Variability
49.7; 74.0
PRIMARY
Target Selection Accuracy
96.3; 94.5
PRIMARY
Information Transfer Rate
45.8; 36.6
PRIMARY
AAC Device Usability
4.7; 4.3

Summary

This project will test the feasibility of developing a smart augmentative or alternative communication (AAC) system that is effective in delivering communication capabilities that automatically adapt to the users' physical abilities.

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04247828). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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