Multisensory Augmentation for Post-stroke Standing Balance

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multisensory Augmentation to Improve the Standing Balance of People With Chronic Stroke

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Balance training with sensory augmentation
* Behavioral: Balance training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of at least 21 years; 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sensory Augmentation<br>Participants will receive sensory augmentation in the form of non-invasive vibration, while balance training is performed as described below. | Behavioral: Balance training with sensory augmentation<br>* Participants will complete 20 balance training sessions, in which they are required to keep their balance while standing on a platform that translates under their feet. During training, sensory augmentation will be delivered with an intensity controlled in real-time by their center of pressure motion. The difficulty of the balance training task will progressively increase over successive training sessions.<br>|
| Active Comparator: Control<br>Participants will receive balance training, without any sensory augmentation. | Behavioral: Balance training<br>* Participants will complete 20 balance training sessions, in which they are required to keep their balance while standing on a platform that translates under their feet. During training, no sensory stimulation will be delivered. The difficulty of the balance training task will progressively increase over successive training sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Berg Balance Scale score change | A standard clinical assessment to measure balance performance during various functional tasks | Before and after a 10-week period of balance training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Limits of Stability score (paretic direction) | A standard assessment of how far participants are willing and able to shift their weight toward the paretic leg while standing | Before and after a 10-week period of balance training | 
| Limits of Stability score (non-paretic direction) | A standard assessment of how far participants are willing and able to shift their weight toward the non-paretic leg while standing | Before and after a 10-week period of balance training | 
| Mediolateral center of pressure velocity | A measure of sideways sway, which will be quantified as participants stand on a platform that translates sideways, challenging participant balance | Before and after a 10-week period of balance training | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke