Clinical trial · Observational
Telerehabilitation Cognitive Impairments Following Chemotherapy Usability Study
Home-based Virtual Reality System for the Treatment of Chemotherapy-related Cognitive Impairments
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-Related Cognitive Impairment | — | UNRESOLVED | — |
| Healthy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Usability study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Usability study, healthy volunteers and those with cognitive impairments following chemotherapy
- description
- 2 elderly healthy volunteers and 2 participants with lasting cognitive impairments following chemotherapy for breast cancer. All will perform evaluation of a computer-based experimental system. Participants will be * Female Either healthy or breast cancer survivor; * Age 20 to 65 years; * Have st least 12 years of formal education; * Be English speakers;
- interventionNames
- Other: Usability study
Primary outcomes (1)
- measure
- USE questionnaire to assess the usability of a computerized system
- timeFrame
- At the end of the 4th evaluation session (about 1 month from enrollment)
- description
- A standardized questionnaire to assess the usefulness, satisfaction and ease of use of the experimental system \[Lund, 2001\] when evaluated by study participants. The form consists of 30 questions, each rated on a 7-point Likert scale (1 worst 7 best). The score range for this form is 30 (min) to 210 (max). Participants will also be able to comment in free form on aspects they liked most and least about the device.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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; * 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.
References
Publications (0)
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