Clinical trial NCT05760885: Multisensory Augmentation for Post-stroke Standing Balance
Official title: Multisensory Augmentation to Improve the Standing Balance of People With Chronic Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Stroke
Keywords: Stroke
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-03-08
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to either a Control or an Experimental group. The Experimental group will receive sensory augmentation during balance training, while the Control group will not.
Primary purpose: TREATMENT

Brief summary: Many individuals who experience a stroke have problems with their balance. In part, these balance problems may be due to sensory issues. This study will test whether sensory augmentation has the potential to improve post-stroke balance. Sensory augmentation is a method by which non-invasive vibration is used to enhance the sensory information available to users, which may make it easier to feel where they are and prevent losses of balance.

Detailed description: The objective of this study is to design a novel multisensory augmentation approach to improve the control of standing balance in people with chronic stroke. With sensory augmentation, artificial feedback provides the nervous system with information about the dynamic state of the body, which can be used to prevent losses of balance. This clinical trial will investigate whether multisensory augmentation produces sustained balance improvements when applied as a training device. These potential improvements will be assessed by comparing the results of clinical and biomechanical assessments before and after a 10-week balance training program, in which half of the participants will be randomly assigned sensory augmentation.

Eligibility criteria: Inclusion Criteria:

* Experience of a stroke at least 6 months prior to participation
* Berg Balance Scale score less than 52
* 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
* Provision of informed consent

Exclusion Criteria:

* Resting blood pressure higher than 220/110 mm Hg
* History of unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
* Pre-existing neurological disorders or dementia
* Severe visual impairment
* History of DVT or pulmonary embolism within 6 months
* Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions

Primary outcomes:
measure: Berg Balance Scale score change
timeFrame: Before and after a 10-week period of balance training
Secondary outcomes:
measure: Limits of Stability score (paretic direction)
timeFrame: Before and after a 10-week period of balance training
measure: Limits of Stability score (non-paretic direction)
timeFrame: Before and after a 10-week period of balance training
measure: Mediolateral center of pressure displacement
timeFrame: Before and after a 10-week period of balance training
measure: Mediolateral center of pressure velocity
timeFrame: Before and after a 10-week period of balance training
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center, Charleston, SC
state: South Carolina
Study officials:
affiliation: Ralph H. Johnson VA Medical Center, Charleston, SC
name: Jesse C. Dean, PhD
role: PRINCIPAL_INVESTIGATOR
References: