Telerehabilitation Cognitive Impairments Following Chemotherapy Feasibility Study

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Cognitive Impairment, Mild

In brief

Develop a game-based upper-extremity motor and cognitive rehabilitation system using custom and adaptable virtual reality simulations on a wearable device enhanced with biosensors. Participants are stage II and stage III breast cancer survivors with lasting cognitive impairments following their first round of chemotherapy. They will be randomized 1:1 into an experimental group and a sham control group. Each group will train in the home for 8 weeks, during which they will perform up to 4 rehabilitation sessions/week (based on tolerance). Each session will start with vitals being measured and logged. Each group will have three clinical evaluations: 1) at baseline; 2) at 8 weeks post-baseline; and 3) at 16 weeks from baseline for follow up. Experimental group sessions will consist of increasingly more difficult cognitive training tasks in the form of simulated tasks. Biosensors will be sampled while participants interact with these games while wearing the computer system. Sham control group will have the same number, suration and frequency of sessions, however they will play web games while wearing some the same biosensors. Caregivers of all subjects will receive a laptop to be used in filling subjective evaluation forms and sending messages to research team. Training will be in the home, so caregivers will need to support the trials by ensuring compliance with the protocol. All subjects will undergo standardized clinical evaluations at baseline, at 8 weeks and at 16 weeks from baseline. The subjects in the experimental group will have computerized measures taken during each session, and will fill subjective evaluation forms every 4 weeks of active training.

Key facts

Study ID
NCT04972019
Run by
Bright Cloud International Corp
People needed
40
Starts
2022-02-09
Expected to finish
2022-09-30
Last updated by the study team
2022-05-02

Who can join

Age: 20 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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