Improving balance in stroke survivors using sensory feedback
Multisensory Augmentation to Improve the Standing Balance of People With Chronic Stroke
This study is testing a new way to help stroke survivors improve their balance by using gentle vibrations during a 10-week training program to see if it works better than regular balance exercises.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT05760885 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance standing balance in individuals who have experienced a stroke by utilizing a novel multisensory augmentation approach. The method involves applying non-invasive vibrations to provide artificial feedback to the nervous system, potentially improving the ability to sense body position and prevent falls. Participants will undergo a 10-week balance training program, with half receiving sensory augmentation to assess its effectiveness compared to standard balance training. Clinical and biomechanical assessments will be conducted before and after the training to evaluate improvements in balance control.
Who should consider this trial
Good fit: Ideal candidates are individuals who have had a stroke at least 6 months prior and have a Berg Balance Scale score of less than 52.
Not a fit: Patients with severe cardiovascular issues, uncontrolled diabetes, or pre-existing neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve balance and reduce fall risk for stroke survivors.
How similar studies have performed: While multisensory augmentation is a relatively novel approach, similar studies have shown promise in improving balance in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age of at least 21 years; 2. Experience of a stroke at least 6 months prior to participation; 3. Berg Balance Scale score less than 52 4. Ability to stand independently for at least 1 minute without wearing an AFO or other brace that would preclude delivery of stimulation to the ankle or foot sole 5. Provision of informed consent Exclusion Criteria: 1. Resting blood pressure higher than 220/110 mm Hg 2. History of unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living 3. Pre-existing neurological disorders or dementia 4. Severe visual impairment 5. History of DVT or pulmonary embolism within 6 months 6. Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
Where this trial is running
Charleston, South Carolina
- Ralph H. Johnson VA Medical Center, Charleston, SC — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Jesse C. Dean, PhD — Ralph H. Johnson VA Medical Center, Charleston, SC
- Study coordinator: Jesse C Dean, PhD
- Email: Jesse.Dean@va.gov
- Phone: (843) 792-9566
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.