Balance Training Platform for Balance Disorder

(BATP Trial)

Overseen By Samantha Fuller, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Stroke, Neurological disease, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a proposal to develop a Balanced Reach Training Protocol (BRTP) to evaluate and train dynamic standing balance. The BRTP is based upon the Balanced Reach Test (BRT) that the investigators previously developed and validated. In the BRT subjects stand and point to a target disk moving unpredictably across a large projection screen in front of them without stepping. Body movements undertaken to track the disk are integral to many daily activities and represent an important class of "expected" balance disturbances that can precipitate falls. The BRTP employs engineering and psychophysical methods, and exploits advances in real time computing in a novel and innovative way to more effectively evaluate and train balance function. The BRTP presents a challenging reaching/tracking task that subjects perform at their limit of balance. The BRTP is an objective, quantitative test that can evaluate balance function without floor or ceiling effects, and train balance across the spectrum of aging, disease, and injury.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have poorly controlled hypertension or diabetes, you may not be eligible to participate.

What data supports the effectiveness of the treatment Balanced Reach Assessment and Training Protocol for balance disorders?

Research shows that balance training, like the Balanced Reach Assessment and Training Protocol, can improve balance and mobility in older adults and stroke patients. Studies on similar balance training systems have demonstrated their ability to enhance balance confidence and functional reach, which are important for reducing fall risk. ^{1 2 3 4 5}

How is the Balanced Reach Assessment and Training Protocol (BRTP) treatment different from other balance disorder treatments?

The Balanced Reach Assessment and Training Protocol (BRTP) is unique because it uses a platform like the Nintendo Wii Balance Board to provide real-time visual feedback for balance training, making it a safe, adaptable, and low-cost option for older adults at high risk of falling. ^{1 2 6 7 8}

Research Team

Joseph E Barton, MD PhD

Principal Investigator

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Eligibility Criteria

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.

Inclusion Criteria

Adequate language and neurocognitive function to give adequate informed consent & to participate in testing and training

I am either between 18-40 years old and healthy or I am 60 years or older.

I am between 18 and 40 years old and have not fallen in the past year.

Exclusion Criteria

Clinical history of any health condition that the study team deems would preclude safe completion of the BATP

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

Poorly controlled hypertension (>190/105) on at least two separate occasions

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Assessment

Development and evaluation of the Balance Assessment and Training Platform (BATP) based on the Balanced Reach Test (BRT). Subjects undergo balance assessment using the BATP Assessment Module.

1 week

2 visits (in-person)

Training

Participants undergo three one-hour training sessions over one week using the BATP Training Module to evaluate motor learning effects.

1 week

3 visits (in-person)

Follow-up

Participants are monitored for changes in balance capability and fear of falling using clinical measures.

1 week

1 visit (in-person)

Treatment Details

Interventions

• Balanced Reach Assessment and Training Protocol

Trial Overview 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.

Participant Groups

Group I: STR Experimental Treatment 1 Intervention

Older people who have suffered a stroke

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

The Balance Control Trainer (BCT) demonstrated a strong correlation with the Berg Balance Scale (BBS) in assessing balance in 38 subacute stroke patients, indicating its effectiveness as a balance assessment tool.

The BCT also showed moderate correlations with other balance measures, such as the Timed Up and Go Test and the 6-minute walking test, suggesting it can provide comprehensive insights into balance recovery post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Balance Assessment in Subacute Stroke Patients Using the Balance Control Trainer (BalPro). Song, JW., Kim, JM., Cheong, YS., et al.[2020]

Older adults with high balance confidence (HBC) demonstrated significantly better functional reach abilities compared to those with low balance confidence (LBC) across all tested contexts, indicating that confidence plays a crucial role in balance performance.

The study found that reaching distance improved significantly when participants were given an external target to reach for, even on unstable surfaces, suggesting that incorporating task objects in balance assessments could enhance understanding of an individual's balance capacity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of balance confidence and context on functional reach ability in healthy older adults. Norris, BS., Medley, A.[2011]

Functional reach (FR) is a reliable and precise clinical measure of balance that correlates well with the laboratory measure of center of pressure excursion (COPE), making it a useful tool for assessing stability in individuals aged 21-87 years.

The study found that FR is influenced by factors such as age and height, and it can be used to detect balance impairments and monitor changes in balance performance over time, especially in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional reach: a new clinical measure of balance. Duncan, PW., Weiner, DK., Chandler, J., et al.[2022]

Whole-body reaching (WBR) can effectively provide graded dynamic balance challenges for stroke patients, as demonstrated by significant changes in center-of-pressure shift based on target distance in a study of 23 individuals with hemiplegia.

While WBR showed potential as a dynamic balance measure, it had limitations in assessing lateral stability, indicating that it may need to be combined with other assessments for a comprehensive evaluation of balance in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-body reaching as a measure of dynamic balance in patients with stroke. Chern, JS., Yang, SW., Wu, CY.[2022]

An 8-week balance training program using the Biodex balance system significantly improved balance and mobility in a group of 18 elderly individuals, with results showing a p-value of less than 0.001 for the intervention group.

In contrast, the control group that received no intervention showed no significant improvements, highlighting the efficacy of the Biodex balance training in reducing fall risk among older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training on Biodex balance system improves balance and mobility in the elderly. Siddiqi, FA., Masood, T.[2019]

The Balance Master (BM) tool demonstrated high test-retest reliability for dynamic balance assessments in stroke patients, particularly for tasks involving shifting the center of gravity, with intraclass correlation coefficients (ICCs) of 0.84 for movement path and 0.88 for movement time.

Dynamic balance measures from the BM were found to have concurrent validity with established balance assessments, such as the Berg Balance Scale and gait velocity, indicating that these measures are effective indicators of functional balance performance in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability and validity of measures obtained from stroke patients using the Balance Master. Liston, RA., Brouwer, BJ.[2022]

The Nintendo 'Wii Balance Board' (WBB) has been adapted to create a safe and low-cost platform for balance training and testing in older adults at high risk of falling.

This technology allows for real-time visual feedback of a participant's center of pressure (COP), enabling tailored diagnostic and training programs that can help improve balance function safely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing and training standing balance in older adults: a novel approach using the 'Nintendo Wii' Balance Board. Young, W., Ferguson, S., Brault, S., et al.[2022]

The balance assessment software developed using the Nintendo Wii Balance Board demonstrated high reliability, with inter-rater reliability scores ranging from 0.79 to 0.89 and intra-rater reliability scores from 0.70 to 0.92, indicating it can consistently measure balance in individuals.

This tool also showed strong concurrent validity when compared to a laboratory-grade force platform, making it a practical and cost-effective option for balance assessments in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validity and reliability of balance assessment software using the Nintendo Wii balance board: usability and validation. Park, DS., Lee, G.[2022]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Balance Assessment in Subacute Stroke Patients Using the Balance Control Trainer (BalPro). [2020]

2. United States pubmed.ncbi.nlm.nih.gov

The effect of balance confidence and context on functional reach ability in healthy older adults. [2011]

3. United States pubmed.ncbi.nlm.nih.gov

Functional reach: a new clinical measure of balance. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Whole-body reaching as a measure of dynamic balance in patients with stroke. [2022]

5. Pakistan pubmed.ncbi.nlm.nih.gov

Training on Biodex balance system improves balance and mobility in the elderly. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Reliability and validity of measures obtained from stroke patients using the Balance Master. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Assessing and training standing balance in older adults: a novel approach using the 'Nintendo Wii' Balance Board. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Validity and reliability of balance assessment software using the Nintendo Wii balance board: usability and validation. [2022]