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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

Must not have

For ages 60 and older-Dementia based on Montreal Cognitive Assessment (MOCA) score of less than 23 for more than 9th grade education

Congestive heart failure or valvular dysfunction symptomatic with ordinary activities (NYHA II)

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

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am 60 or older with a MOCA score below 23 and have more than a 9th grade education.

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I have heart issues that affect me during daily activities.

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My diabetes is not well-managed (HbA1c >10).

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I am between 18 and 40 years old and have had a stroke or issues with movement or sensation.

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I feel dizzy or faint when I stand up.

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I have a neurological condition other than stroke that affects my balance or movement.

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.