Telerehabilitation Cognitive Impairments Following Chemotherapy Usability Study (NCT04839588) | Clinical Trial Compass
CompletedNot Applicable
Telerehabilitation Cognitive Impairments Following Chemotherapy Usability Study
United States4 participantsStarted 2021-06-07
Plain-language summary
Develop a game-based upper-extremity motor and cognitive rehabilitation system using custom and adaptable virtual reality simulations.
Perform usability study on 2 elderly healthy volunteers and 2 breast cancer survivors with lasting cognitive impairments following chemotherapy, so to improve the product design. The usability evaluation will be done at NJ Bioscience Center (North Brunswick, NJ).
Who can participate
Age range20 Years – 65 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
At NJ Bioscience Center Healthy Volunteers
* Female
* Age 20 to 65;
* Good or corrected hearing;
* Good or corrected vision;
* No motor or cognitive impairments;
* English speakers;
* Those with low propensity for simulation sickness (as determined by the Simulation Sickness Questionnaire \[Kennedy et al, 1993\]).
* Either healthy or having had stage II or stage III breast cancer;
* Montreal Cognitive Assessment (MoCA) Score 10-25 indicating mild to moderate impairment \[Chapman 2016\] or 26-30 indicating normal cognition;
EXCLUSION CRITERIA
* Male;
* Female participants younger than 20 or older than 65;
* High propensity for simulation sickness (as determined by Simulation Sickness Questionnaire screening);
* Those with severe visual neglect or legally blind;
* Those with severe hearing loss or deafness;
* Those with uncontrolled hypertension (\>190/100 mmHg);
* Those with severe cognitive impairment (MoCA score\<10);
* Current diagnosis of moderate-severe depression (Beck Depression Inventory II score of 17-63);
* a history of psychiatric illness, defined as serious psychiatric illness such as bipolar mood disorder and schizophrenia, or requiring psychiatric hospitalization.
* a history of or current substance abuse;
* a previous head injury resulting in loss of consciousness;
* a prior diagnosis of neurological illness;
* a current or prior diagnosis of brain cancer;
* non-English speakers;
* Those unable to reliable participate in pre-study assessment due to any reason…
What they're measuring
1
USE questionnaire to assess the usability of a computerized system
Timeframe: At the end of the 4th evaluation session (about 1 month from enrollment)