A platform for assessing and training balance in individuals with stroke and healthy adults
An Engineering-Based Balance Assessment and Training Platform
This study is testing a new balance training program using virtual reality to help people who have had a stroke improve their balance skills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT03994770 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a Balanced Reach Training Protocol (BRTP) to evaluate and enhance dynamic standing balance in individuals, particularly focusing on those with stroke-related balance deficits. The BRTP utilizes an innovative approach that combines engineering and psychophysical methods, employing real-time computing to assess balance through a challenging reaching task. Participants will engage in a balance assessment and training platform that incorporates virtual reality technology to improve their balance function objectively and quantitatively. The study will also evaluate the reliability of the assessment module and the effectiveness of the training module in promoting motor learning.
Who should consider this trial
Good fit: Ideal candidates include healthy adults aged 18-40 with no history of falls and individuals aged 60 and older who have experienced a stroke with persistent motor function deficits.
Not a fit: Patients with health conditions that would prevent safe participation in the balance assessment or those with a history of stroke or orthopedic deficits under the age of 40 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve balance training methods, reducing fall risk and enhancing mobility for patients with stroke and healthy individuals.
How similar studies have performed: Other studies have shown promise in using technology-based interventions for balance training, but this specific approach utilizing virtual reality and real-time computing is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-40 years old and in good health; 60 years and older * For Ages 60 or older-stroke with persistent motor function deficit. * For ages 18-40-experienced no falls in the past year. Fall is defined as a fall that occurs under conditions that an able body individual would not fall. * Able to perform the balanced reach task without assistive devices for 90 seconds * Able to perform a sit-to-stand with minimal assistance and walk 10 meters without human assistance * Adequate language and neurocognitive function to give adequate informed consent \& to participate in testing and training * Vision adequate to see a 1 inch diameter black disk against a white background at 3 feet * Able to tolerate the use of Virtual Reality eyewear for \~10 minutes Exclusion Criteria: Clinical history of: * Any health condition that the study team deems would preclude safe completion of the BATP * For ages 18-40-History of a stroke, orthopedic deficits, or sensorimotor deficits * Body Mass Index (BMI) \>40 * Excessive daily alcohol consumption (\>3 oz. liquor; \>12 oz. wine; or \>36 oz. beer) or illicit drug abuse * For ages 60 and older-Dementia based on Montreal Cognitive Assessment (MOCA) score of less than 23 for more than 9th grade education. * Neurological disease other than stroke, such as Parkinson's disease. Vestibular disorders sufficient to preclude safe completion of the BATP or MMBI * Poorly controlled hypertension (\>190/105) on at least two separate occasions * Poorly controlled type 1 or 2 diabetes (HbA1c \>10) * Recent hospitalization for severe disease or surgery (\<3 months) * Congestive heart failure or valvular dysfunction symptomatic with ordinary activities (NYHA II) * Self-reported Pregnancy * Symptomatic orthostatic hypotension
Where this trial is running
Baltimore, Maryland
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Joseph E. Barton, MD PhD — Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
- Study coordinator: Joseph E Barton, MD PhD
- Email: jbarton@som.umaryland.edu
- Phone: (202) 337-5921
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.