Telerehabilitation Cognitive Impairments Following Chemotherapy Usability Study
Completed
Conditions studied: Chemotherapy-Related Cognitive Impairment, Healthy
In brief
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).
Key facts
- Study ID
- NCT04839588
- Run by
- Bright Cloud International Corp
- People needed
- 4
- Starts
- 2021-06-07
- Expected to finish
- 2021-12-31
- Last updated by the study team
- 2022-04-28
Who can join
Age: 20 and older, up to 65. Sex: female. Healthy volunteers: accepted.
You may not qualify if…
- 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;
- Those with co-morbidities limiting arm and neck motor function (ex. lymphedema, chronic pain, severe arthritis);
- Less than 1 month post first chemotherapy regimen or starting chemotherapy during 16 weeks post screening (as chemotherapy during study participation is a confounding factor);
- Those with Stage IV (metastatic) breast cancer will be excluded;
- Those presenting with multiple cancers, such as breast and arm bone cancer, or breast and brain cancer;
- Those who are unwilling to allow a home inspection to ascertain Internet quality, determine best placement for the experimental or sham systems, for installation and removal of the systems and necessary repairs.
Where it is running
- Bright Cloud Int'l Corp — North Brunswick, New Jersey, United States
- New Jersey Bioscience Center — North Brunswick, New Jersey, United States
Full record on ClinicalTrials.gov
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