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Balance Training Platform for Balance Disorder (BATP Trial)

N/A

Recruiting

Led By Joseph E. Barton, MD PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

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

Must have

Able to perform a sit-to-stand with minimal assistance and walk 10 meters without human assistance

Able to tolerate the use of Virtual Reality eyewear for ~10 minutes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assess change between base line (just prior to training) and last 90 seconds of last training session at end of 1 week

Awards & highlights

BATP Trial Summary

This trial is proposing to develop a protocol to more effectively evaluate and train balance function by employing engineering and psychophysical methods in a novel and innovative way.

Who is the study for?

This trial is for adults who have balance disorders or have had a stroke. Participants must be able to reach without help and see well at close distances. Younger adults (18-40) should be healthy with no falls in the past year, while older adults (60+) should be able to stand up and walk unaided but may have motor deficits from a stroke.Check my eligibility

What is being tested?

The study is testing a new Balance Reach Training Protocol (BRTP), which challenges participants to track a moving target on screen without stepping. It's designed to assess and improve balance by mimicking everyday situations that could cause falls.See study design

What are the potential side effects?

Since this intervention involves physical activity related to balance, potential side effects might include dizziness or discomfort when using virtual reality eyewear, muscle strain, fatigue, or an increased risk of falling during the assessment.

BATP Trial Eligibility Criteria

Inclusion Criteria

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

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I can stand up from a chair and walk 10 meters without help.

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I can use Virtual Reality glasses for about 10 minutes without discomfort.

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I can balance and reach for 90 seconds without help.

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I am 60 or older and have lasting muscle control issues from a stroke.

BATP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assess change between base line (just prior to training) and last 90 seconds of last training session at end of 1 week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assess change between base line (just prior to training) and last 90 seconds of last training session at end of 1 week

This trial's timeline: 3 weeks for screening, Varies for treatment, and assess change between base line (just prior to training) and last 90 seconds of last training session at end of 1 week for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Root Mean Squared Deviation between Center of Mass and Center of Base of Support (RMSD)

Secondary outcome measures

Falls Efficacy Scale

Multi-Directional Reach Test

BATP Trial Design

1Treatment groups

Experimental Treatment

Group I: STRExperimental Treatment1 Intervention

Older people who have suffered a stroke

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,611 Previous Clinical Trials

3,305,264 Total Patients Enrolled

Joseph E. Barton, MD PhDPrincipal InvestigatorBaltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

1 Previous Clinical Trials

90 Total Patients Enrolled

Media Library

Balanced Reach Assessment and Training Protocol Clinical Trial Eligibility Overview. Trial Name: NCT03994770 — N/A

Balance Disorder Research Study Groups: STR

Balance Disorder Clinical Trial 2023: Balanced Reach Assessment and Training Protocol Highlights & Side Effects. Trial Name: NCT03994770 — N/A

Balanced Reach Assessment and Training Protocol 2023 Treatment Timeline for Medical Study. Trial Name: NCT03994770 — N/A

Frequently Asked Questions

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

Is this investigation actively seeking participants?

"As detailed on clinicaltrials.gov, this medical investigation is presently accepting participants. The trial was initially posted on November 15th 2021 and most recently updated on July 29th 2022."

Answered by AI

What prerequisites do individuals need to meet in order to be included in this trial?

"This clinical trial is seeking 20 stroke patients aged between 65 and 86 years. Qualified candidates must have had an ischemic stroke with residual hemiparetic gait, possess the cognitive capacity to comprehend and complete training tasks, be able to wear Augmented Virtual Reality eyewear for up to 10 minutes without discomfort or fatigue, and demonstrate capability in performing BATP Assessment Tasks sans any assistive devices or handholds."

Answered by AI

Is the minimum age criterion for this trial set at twenty years or older?

"As stipulated by the prerequisites for this medical research, participants must be aged between 65 and 86."

Answered by AI

To what extent is enrollment progressing in this investigation?

"Yes, the clinicaltrials.gov data verifies that recruitment is currently underway for this trial. The medical study was initially announced on November 15th 2021 and subsequent edits were made July 29th 2022. Participants are being sought at 1 site with a maximum of 20 individuals in total needed to complete the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Engineering-Based Balance Assessment and Training Platform

2021. "An Engineering-Based Balance Assessment and Training Platform". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03994770.

All > Stroke