Multisensory Augmentation for Post-stroke Standing Balance

Stroke Clinical Trial

— MAB  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05760885
• Other study ID #: A4545-R
• Secondary ID: I01RX004545
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: October 1, 2024
• Est. completion date: January 1, 2027

Study information

• Verified date: March 2024
• Source: VA Office of Research and Development
• Contact: Jesse C Dean, PhD
• Phone: (843) 792-9566
• Email: Jesse.Dean[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Balance training with sensory augmentation
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.
• Balance training
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.

Locations

Country	Name	City	State
United States	Ralph H. Johnson VA Medical Center, Charleston, SC	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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