Multisensory Augmentation for Post-stroke Standing Balance (MAB)

VA Office of Research and Development

Status and phase: Enrolling; Early Phase 1

Conditions: Stroke

Treatments: Behavioral: Balance training with sensory augmentation; Behavioral: Balance training

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT05760885

I01RX004545 (U.S. NIH Grant/Contract)

A4545-R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Sensory Augmentation

Experimental group

Description:

Participants will receive sensory augmentation in the form of non-invasive vibration, while balance training is performed as described below.

Treatment:

Behavioral: Balance training with sensory augmentation

Control

Active Comparator group

Description:

Participants will receive balance training, without any sensory augmentation.

Treatment:

Behavioral: Balance training