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 range

20 Years – 65 Years

Sex

FEMALE

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

USE questionnaire to assess the usability of a computerized system

Timeframe: At the end of the 4th evaluation session (about 1 month from enrollment)

Trial details

NCT IDNCT04839588

SponsorBright Cloud International Corp

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-12-31

View on ClinicalTrials.gov More Chemotherapy-Related Cognitive Impairment trials