Telerehabilitation Cognitive Impairments Following Chemotherapy Feasibility Study

Summary

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.

Conditions

• Cognitive Impairment, Mild

Interventions

DEVICE

Telerehabilitation Experimental Group

Experimental training will occur in the home. The experimental training will last 8 weeks, each week having up to 4 sessions of therapeutic game play (based on tolerance). Each session will start with vitals and subjective pain level being measured and logged. They will wear a computer system modified with biosensors, then do motor and cognitive baselines. Subsequently, participants will play an increasing number of games, targeted at cognitive domains of executive function (primary), memory and attention. At the end of every session vitals and subjective pain will be measured and logged. Clinical Coordinator will call homes weekly to ascertain general health and issues with participation. At the end of week 4 and 8 participants and their caregivers in the experimental group will fill a subjective evaluation questionnaire to gauge perceived benefits and technical difficulties when using the experimental system. Questions will be scored on a 5-point Likert scale.

OTHER

Telerehabilitation Sham Control Group

Sham control group will train playing web games while wearing a biosensor connected to a laptop provided, showing the web games. However biosensor data will not be used to control game difficulty. Sham group controls will start every session with vitals and subjective pain levels being measured and logged. Then participants will play the same frequency and duration of sessions, however those will consist of web games training the same domains (memory, focusing, executive function). Interaction will be through a mouse, and data will be downloaded to a server maintained by the company doing the web games. Data will then be transferred to the research team. At the end of every session vitals and subjective pain levels will again be measured and logged. Once a week the Clinical Coordinator will call the home to ascertain general health and determine is there were issues with that week participation.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Rutgers, The State University of New Jersey

  collaborator OTHER

• Bright Cloud International Corp

  lead INDUSTRY

Principal Investigators

• Grigore C Burdea, PhD · Bright Cloud Int'l Corp

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-02-09

Primary Completion

2022-09-30

Completion

2022-09-30

Countries

• United States

Study Locations