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BITS Visual Intervention for Traumatic Brain Injury

N/A

Waitlist Available

Led By Heidi Fagan, OTR/L

Research Sponsored by Gaylord Hospital, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Admitted for inpatient rehabilitation

Must have an acute or subacute (diagnosed within the last 3 months) neurological diagnosis with a visual field deficit as verified by occupational therapist via confrontation testing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up prior to enrollment to determine eligibility. potential participants are screened within 72 hours of admission to the inpatient rehabilitation program.

Awards & highlights

Study Summary

This trialwill compare how well visual field awareness improves after using conventional vision exercises or interactive BITS touch screen technology. 30 participants will be split into two groups and monitored for safety.

Who is the study for?

This trial is for adults over 18 with recent neurological issues causing visual field deficits, who can consent and follow simple instructions. They must be in rehab, able to use a touch screen with their arms, and sit for at least 30 minutes. It's not for those with unstable vitals, severe cognitive or physical impairments, certain heart conditions, legal blindness history, or very recent severe neurological events.Check my eligibility

What is being tested?

The study compares traditional table top vision exercises against the BITS touchscreen technology in improving visual field awareness after a brain injury. Participants are split into two groups: one uses conventional methods while the other uses BITS tech during rehabilitation sessions.See study design

What are the potential side effects?

Safety is monitored through reported adverse events; however specific side effects aren't listed as it's more about comparing effectiveness of different therapy types rather than medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently in a hospital for rehabilitation.

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I was diagnosed with a neurological condition affecting my vision in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ prior to enrollment to determine eligibility. potential participants are screened within 72 hours of admission to the inpatient rehabilitation program.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~prior to enrollment to determine eligibility. potential participants are screened within 72 hours of admission to the inpatient rehabilitation program.

This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to enrollment to determine eligibility. potential participants are screened within 72 hours of admission to the inpatient rehabilitation program. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Bells Test

Confrontation Testing

Kinetic Field Assessment

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Bioness Integrated Therapy System Visual InterventionExperimental Treatment1 Intervention

Intervention will includes six sessions using the Bioness Integrated Therapy System for 20 minutes using the programs of visual scanning, visual pursuits and/or visual motor.All activities will be conducted with an occupational therapist/investigator.

Group II: Table Top Visual InterventionActive Control1 Intervention

Interventions will include six, 20 minute sessions using pen and paper word search, scanning activities, and saccade visual training. All activities will be conducted with an occupational therapist/investigator.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gaylord Hospital, IncLead Sponsor

6 Previous Clinical Trials

288 Total Patients Enrolled

Connecticut Community FoundationUNKNOWN

Heidi Fagan, OTR/LPrincipal InvestigatorGaylord Specialty Healthcare

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this clinical trial still possible?

"The study, which was initially posted on August 1st 2021 and modified on November 16th 2022, is not looking to enrol patients at this time. However, there are an abundance of other studies that require participants right now - a total of 2013 clinical trials in fact."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of Bioness Integrated Therapy System (BITS) Touch Screen Technology to Improve Field Awareness

Heidi Fagan 2021. "Evaluation of Bioness Integrated Therapy System (BITS) Touch Screen Technology to Improve Field Awareness". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04930822.

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