Multisensory Balance Training for Stroke

(MAB Trial)

Overseen By Aaron E Embry, DPT

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: VA Office of Research and Development

Disqualifiers: Hypertension, Cardiac arrhythmias, Neurological disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist individuals who have experienced a stroke and face balance issues. Researchers are testing whether sensory augmentation, which uses gentle vibrations to enhance sensation, can improve balance. Participants will receive either balance training with these vibrations (balance training with sensory augmentation) or balance training alone. Individuals who had a stroke over six months ago and can stand without support might be suitable candidates.

As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants an opportunity to contribute to groundbreaking advancements in stroke recovery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that balance training with sensory help is generally safe and well-tolerated. Studies have found that whole-body vibration therapy, a similar method, can improve balance and daily activities in stroke patients. This approach avoids surgery or other invasive procedures, typically reducing the risk of serious side effects.

As this study is in an early stage, the treatment is still undergoing safety testing. However, because the therapy is non-invasive, it likely poses fewer risks than surgical treatments. For any concerns, discussing them with the study team can clarify possible risks based on individual health conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the multisensory balance training for stroke because it introduces sensory augmentation through non-invasive vibration. This approach aims to enhance the brain's ability to adapt and improve balance by providing additional sensory feedback, which could potentially accelerate recovery. Unlike traditional balance training that relies solely on physical exercises, this method uniquely integrates sensory input to promote better coordination and stability.

What evidence suggests that this trial's treatments could be effective for improving post-stroke balance?

In a previous study, sensory integration training helped stroke patients improve their balance. Research shows that about 83% of stroke patients struggle with balance, and exercises focused on balance can help. New methods that combine different balance exercises have improved balance and reduced falls in stroke survivors. Additionally, balance training has enhanced movement and daily activities, with benefits lasting for months. This trial will compare two approaches: balance training with sensory augmentation, which uses vibrations to improve sensory feedback, and standard balance training without sensory augmentation. These findings suggest that balance training with sensory augmentation could help stroke patients improve their balance. ^{3 6 7 8 9}

Who Is on the Research Team?

Jesse C. Dean, PhD

Principal Investigator

Ralph H. Johnson VA Medical Center, Charleston, SC

Are You a Good Fit for This Trial?

This trial is for adults over 21 who had a stroke at least 6 months ago and are now having trouble with balance, as shown by scoring less than 52 on the Berg Balance Scale. They must be able to stand unaided for a minute but can't have certain heart conditions, other neurological disorders, severe vision loss, recent serious blood clots or uncontrolled diabetes.

Inclusion Criteria

I am 21 years old or older.

Provision of informed consent

I can stand on my own for at least 1 minute without any support or braces.

Exclusion Criteria

I have diabetes with recent weight loss, diabetic coma, or frequent insulin reactions.

I have severe difficulty seeing.

You have a pre-existing neurological disorder or dementia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 10-week balance training program with or without sensory augmentation

10 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Balance training
• Balance training with sensory augmentation

Trial Overview

The study is looking into whether adding non-invasive vibration (sensory augmentation) to balance training helps improve standing balance in people who've had a stroke. Participants will receive either regular balance training or enhanced training with sensory feedback.

How Is the Trial Designed?

Group I: Sensory Augmentation Experimental Treatment 1 Intervention

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

Group II: Control Active Control 1 Intervention

Participants will receive balance training, without any sensory augmentation.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

A 4-week weight-shift training program significantly improved balance control in nine male stroke survivors, as evidenced by increased scores on the Berg Balance Scale and reduced center of pressure (CoP) sway area and velocity during quiet standing.

While the training enhanced postural control during forward reach tasks, it did not affect weight distribution, indicating that while balance can be improved, other aspects of stability may require different interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of weight-shift training on balance control and weight distribution in chronic stroke: a pilot study. Tsaklis, PV., Grooten, WJ., Franzén, E.[2016]

In a study of 101 hemiparetic stroke survivors, those with normal somatosensory function showed significantly better improvements in balance, gait, and daily living activities after 4 weeks of rehabilitation compared to those with impaired or absent sensory function.

The findings suggest that better somatosensory function is correlated with enhanced motor recovery, indicating the importance of sensory assessment in rehabilitation strategies for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A precision neurorehabilitation using SSEP for early detection of sensory deficit and restoration of the motor recovery in balance, gait and activities of daily living in acute stroke. Yoon, H., Park, C., Park, I., et al.[2021]

Balance training using the Force Platform with Visual Feedback technique significantly improved balance and functional outcomes in chronic stroke survivors, as evidenced by statistically significant improvements in all measured outcomes after 20 training sessions.

Out of 45 participants, 89.9% completed the training, and improvements were maintained at a 3-month follow-up, highlighting the potential long-term benefits of this intervention for stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-stroke balance training: role of force platform with visual feedback technique. Srivastava, A., Taly, AB., Gupta, A., et al.[2022]

Stroke survivors using the Motorized Ankle Stretcher (MAS) showed significant improvements in balance control, specifically in center of pressure (COP) metrics, after four weeks of ankle stretching exercises compared to those using a traditional stretching board.

The improvements in balance were maintained one month after the intervention, suggesting that the MAS could be an effective tool for enhancing balance in stroke survivors in both home and clinical environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Technology-Assisted Ankle Rehabilitation on Balance Control in Stroke Survivors. Yoo, D., Kim, DH., Seo, KH., et al.[2020]

In a randomized controlled trial involving 37 chronic stroke patients, those who engaged in a cognitive-motor dual-task using auditory cues showed significant improvements in balance compared to those who only walked on a treadmill.

The dual-task group demonstrated enhanced balance metrics, including mediolateral and anteroposterior sway velocities, indicating that integrating cognitive tasks during physical activity can be beneficial for rehabilitation in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the cognitive-motor dual-task using auditory cue on balance of surviviors with chronic stroke: a pilot study. Choi, W., Lee, G., Lee, S.[2019]

In a study involving seven chronic hemiparetic stroke patients, a 20-session balance exercise program significantly improved both postural stability and walking ability, as measured by the Sensory Organization Balance Test and the Ten Metre Walking Test.

The improvements in balance and walking speed were not only immediate but also sustained one week after the treatment, highlighting the effectiveness of targeted rehabilitation for sensorimotor integration deficits in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation of sensorimotor integration deficits in balance impairment of patients with stroke hemiparesis: a before/after pilot study. Smania, N., Picelli, A., Gandolfi, M., et al.[2022]

Visual and haptic vertical stimulation significantly improved balance in 25 post-stroke patients, as measured by various center of pressure (COP) parameters, compared to no stimulation.

Visual stimulation was found to be more effective than haptic stimulation in enhancing balance, indicating that visual cues may play a crucial role in rehabilitation for post-stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of visual and haptic vertical stimulation on standing balance in stroke patients. Hong, SH., Im, S., Park, GY.[2021]

A pilot study involving three subjects with hemisensory loss in their lower limb showed that 2 weeks of intensive sensory training led to significant improvements in light touch appreciation for two participants and some postural control measures for the third.

The results suggest that sensory training can be beneficial for lower limb recovery post-stroke, highlighting the importance of motivation and functional application in therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of sensory retraining for the hemiparetic foot post-stroke. Hillier, S., Dunsford, A.[2022]

Targeted sensory training over six weeks significantly improved balance in aging individuals (ages 50-80), including both healthy participants and those with chronic stroke, as measured by the balance error scoring system (BESS).

The training focused on enhancing visual and somatosensory inputs during balance exercises, showing that simple exercises can effectively reduce fall risk in the aging population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensory integration training improves balance in older individuals. Thompson, LA., Savadkoohi, M., de Paiva, GV., et al.[2022]

In a pilot study involving 21 stroke patients with sensory deficits, sensory retraining showed significant improvements in light touch sensation and postural control, as well as gait performance over time.

However, the study did not find significant differences between the sensory retraining and sham intervention groups, indicating that more research with a larger sample size is needed to determine the effectiveness of sensory retraining in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensory retraining of the lower limb after acute stroke: a randomized controlled pilot trial. Lynch, EA., Hillier, SL., Stiller, K., et al.[2022]

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