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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help researchers understand and improve balance, particularly in individuals who have had a stroke or are at risk of falling. The focus is on a new training system, the Balanced Reach Assessment and Training Protocol, which tests balance by having participants reach for a moving target on a screen without stepping. This trial may suit older adults who have had a stroke and still experience balance issues, or younger adults who haven't fallen in the past year and can stand and walk unaided. Participants should also be comfortable using virtual reality gear and have adequate vision to see the test target.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance balance training methods for many.

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 prior data suggests that the Balanced Reach Training Protocol is safe for evaluating and training balance?

Research has shown that balance training can be safe and helpful for people recovering from a stroke. Techniques like the Balanced Reach Training Protocol (BRTP) improve balance without causing major side effects. In similar studies, participants did not report serious problems, suggesting that this type of therapy is generally safe.

The BRTP is designed to be both challenging and manageable, allowing participants to work at their own pace. This careful design helps ensure participation without unnecessary risk. Overall, balance training methods like BRTP are considered a promising and safe way to improve balance after a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Balanced Reach Assessment and Training Protocol because it offers a fresh approach to tackling balance disorders in older individuals who have suffered a stroke. Unlike standard treatments that might focus on medication or generalized physical therapy, this protocol specifically targets balance improvement through a structured training platform. It aims to directly enhance balance skills, potentially leading to better mobility and reduced fall risk. By providing a more tailored and active training method, it could significantly improve the quality of life for stroke survivors.

What evidence suggests that the Balanced Reach Training Protocol is effective for balance disorders?

Research has shown that stroke patients can greatly improve their balance through specific training. One study found that stroke survivors who practiced balance exercises in low-vision conditions improved more than those who did not. Another study discovered that various types of balance training, such as exercises focusing on the inner ear and performing dual tasks, also enhanced balance and walking. This trial will evaluate the effectiveness of the Balanced Reach Training Protocol, designed to enhance balance in stroke survivors. ^{2 3 5 6 7}

Who Is on the Research Team?

Joseph E Barton, MD PhD

Principal Investigator

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

Are You a Good Fit for This Trial?

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

You can see a black disk that is 1 inch in diameter against a white background from a distance of 3 feet.

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-8-2021-697dd

Balance Training Platform for Balance Disorder (BATP 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6661695/

Rehabilitation for balance impairment in patients after stroke The aim of this study is to summarise evidence and identify the most effective rehabilitation therapy for poststroke balance impairment.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8752821/

Stroke Patients Showed Improvements in Balance in ... The result of our study suggested that stroke subjects who received balance training in vision restriction conditions could improve the balance more than ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06555016

Optimal Intensity of Reactive Balance Training Post-stroke The purpose of this study is to determine the optimal intensity of RBT post-stroke. The 'optimal' intensity is the intensity that improves reactive balance ...

5. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.040663

Impact of Vestibular Rehabilitation and Dual‐Task Training ... The evidence supports that VRT, can probably improve balance, and DTT may improve gait outcomes among survivors of late subacute and chronic stroke.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04359888

A Balanced Assessment and Training Protocol (BATP) to ... Outcome Measures: The following "clinical measures" of balance, reach, and fall risk will be used to asses training effects induced by the BATP and MMBI. 1.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10875131/

Advances in balance training to prevent falls in stroke ... The commonly used outcome measures include clinical balance test, such as Berg balance scale (BBS), Timed Up-and-Go Test (TUG), Fall Risk Index ...