Recruiting

Telerehabilitation

Sponsor:

Bright Cloud International Corp

Code:

NCT04972019

Conditions

Cognitive Impairment, Mild

Eligibility Criteria

Sex: Female

Age: 20 - 65

Healthy Volunteers: Not accepted

Interventions

Telerehabilitation Experimental Group

Telerehabilitation Sham Control Group

Study Details

Brief 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

Study ID

NCT04972019

Start date

Feb 9, 2022

Status verified date

Apr, 2022

Completion date

Sep 30, 2022

Anticipated

Primary completion date

Sep 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 20 - 65

Healthy Volunteers: Not accepted

Recruitment will be at Robert Wood Johnson Medical School and at Rutgers NJ Cancer Institute.

INCLUSION CRITERIA FOR CANCER SURVIVORS WITH CRCI SUBSEQUENT TO CHEMOTHERAPY

  • Female breast cancer survivor;
  • Age 20 to 65 years;
  • At least 12 years of formal education;
  • Not participating in other studies;
  • Generally healthy and active pre-diagnosis (based on self-report);
  • Chemotherapy related cognitive impairments with a Montreal Cognitive Assessment (MoCA) Score 10-25 indicating mild to moderate impairment \[Chapman 2016\];
  • Having had invasive (Stages II and III) breast cancer;
  • Had completed standard course of chemotherapy with Anthracyclines: doxorubicin (Adriamycin) \& epirubicin (Ellence), or Taxanes: docetalex (Taxotere) \& paclitaxel (Taxol), or Combination therapies with like carboplatin, cyclophosphamide (Cytoxan), and fluorouracil (5-FU).
  • At least one month post completion of first chemotherapy regimen.
  • English speakers so as to comprehend game instructions, feedback forms, clinical exam questionnaires, and neuropsychological testing;
  • Adult caregivers male or female can be either spouse, child, or a significant other living in the same home and available for the study;
  • Absence of lymphedema or other co-morbidity limiting upper extremity function;
  • Low propensity for simulation sickness (as measured by Simulation Sickness questionnaire);
  • Living in the community in Central Jersey so to facilitate researchers travel to home for system installation and/or repairs,
  • Living with a caregiver willing to support trials and be present during sessions;
  • Good upper extremity motor function, able to move arms (at least 30 degrees shoulder, 30 degrees elbow and 30 degrees index finger); 20
  • Willing to allow home inspections to ascertain internet conditions in the home, to determine best placement for the experimental system, to install and remove system, and to provide repairs if needed.

EXCLUSION CRITERIA FOR PARTICIPANTS WITH CRCI POST CHEMOTHERAPY

  • 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.

INCLUSION CRITERIA FOR CAREGIVERS OF PARTICIPANTS WITH CRCI POST CHEMOTHERAPY

  • Age 18 or older;
  • Generally in good overall health; 21
  • Able to converse in English;
  • Willing and able to participate in the study;
  • Lives with the individual with CRCI post chemotherapy, or comes at least 4 days a week or at least present during home sessions;
  • Willing to report on standard of care (e. g. any other treatments during the study) on a weekly basis while enrolled;
  • Willing to report on experimental system issues and to fill periodic evaluation questionnaires.

EXCLUSION CRITERIA FOR CAREGIVERS OF INDIVIDUALS WITH CRCI POST CHEMOTHERAPY

  • Cardiac, orthopedic, neurologic, psychiatric symptoms limiting participation;
  • Dementia;
  • Aggressive behaviors (observation);
  • Domestic disputes or unstable home environment limiting home based training.

Reasons for exclusion based on these impairments relate to the nature of the virtual rehabilitation training, where participants need to be able to perceive the graphics scene on a head-mounted display, be able to hold game controllers in both hands and interact with therapeutic games, hear the simulation sounds, be aware of their surroundings and be able to sustain rapid arm/fingers movement. While the proposed system is considered safe, malignancies in the upper body, cardiac, orthopedic or neurologic issues can pose bodily risks due to intense activity, risks which we want to minimize. Pregnancy is an exclusion since pregnant women are more prone to simulation sickness. The evaluation instruments are in English, thus subjects who do not speak the language will not comprehend the evaluation questions or instructions, which will bias responses.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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 being measured and logged. Data will be uploaded on a secure cloud server to which clinicians will have access.

sham comparator: Telerehabilitation control group

Participants will perform web-based game play while wearing sham equipment. Duration of sessions will be fixed and frequency of sessions will equal that of the experimental group training. Over the total training the control group will have an equal duration of training with the experimental group.

Interventions

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.

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.

Primary outcome measure

  • Change in Montreal Cognitive Assessment (MoCA) [ Time Frame: Change from Screening at baseline, to 8 weeks and to 16 weeks from baseline ]
  • Change in Test of Pre-morbid Functioning [ Time Frame: Change from baseline, to 8 weeks and to 16 weeks from baseline ]
  • Change in NAB Attention Module [ Time Frame: Change from baseline, to 8 weeks and to 16 weeks from baseline ]
  • Change in NAB Functioning Word Module [ Time Frame: Change from baseline, to 8 weeks and to 16 weeks from baseline ]
  • Change in Trail Making Test [ Time Frame: Change from baseline, to 8 weeks and to 16 weeks from baseline ]
  • Change in Hopkins Verbal Learning Test Revised [ Time Frame: Change from baseline, to 8 weeks and to 16 weeks from baseline ]
  • Change in Brief Visuo-spatial Memory Test, Revised (BVMT-R) [ Time Frame: Change from baseline, to 8 weeks and to 16 weeks from baseline ]

Central Contacts and Locations

Central contacts

Locations

Rutgers University Rober Wood Johnson Medical School

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Jasdeep Hundal, PsyD

jsh164@rwjms.rutgers.edu

Bright Cloud Int'l Corp

Recruiting

North Brunswick, New Jersey, United States, 08902

Contacts

Principal Investigator:

Grigore C Burdea, PhD

More Information

Sponsor

Bright Cloud International Corp

Last update posted

May 2, 2022

Last verified

Apr, 2022

Keywords

  • chemotherapy
  • cognitive impairments
  • breast cancer
  • executive functions

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bright Cloud International Corp on 2022-05-02.