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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Multisensory Balance Training for Stroke?

Research shows that balance training with sensory input, like visual feedback and sensory retraining, can improve balance and walking ability in stroke patients. Studies found that these methods help patients better integrate sensory information, leading to improved postural control and walking speed. ^{1 2 3 4 5}

Is multisensory balance training safe for humans?

Research on balance training, including sensory integration training, suggests it is generally safe for humans, as it has been used to improve balance in both older adults and stroke survivors without reported safety issues. ^{2 5 6 7 8}

How is balance training with sensory augmentation different from other treatments for stroke?

Balance training with sensory augmentation is unique because it focuses on enhancing the integration of sensory inputs (like touch and sight) to improve balance, which is often impaired after a stroke. This approach is different from traditional methods that may not specifically target the sensory integration process, making it a novel way to help stroke patients regain stability and improve their walking ability. ^{2 4 5 9 10}

Research Team

Jesse C. Dean, PhD

Principal Investigator

Ralph H. Johnson VA Medical Center, Charleston, SC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Sensory retraining of the lower limb after acute stroke: a randomized controlled pilot trial. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Post-stroke balance training: role of force platform with visual feedback technique. [2022]

3. England pubmed.ncbi.nlm.nih.gov

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

4. Italy pubmed.ncbi.nlm.nih.gov

Rehabilitation of sensorimotor integration deficits in balance impairment of patients with stroke hemiparesis: a before/after pilot study. [2022]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

The effects of visual and haptic vertical stimulation on standing balance in stroke patients. [2021]

6. England 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. [2019]

7. Netherlands 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. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Sensory integration training improves balance in older individuals. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

The Effects of Technology-Assisted Ankle Rehabilitation on Balance Control in Stroke Survivors. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Effects of weight-shift training on balance control and weight distribution in chronic stroke: a pilot study. [2016]