Electrical Stimulation for Ankle Instability

Overseen By Eman Alsaqabi

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Delaware

Must not be taking: Antibiotics

Disqualifiers: Head injury, Vestibular dysfunction, Neurological disorders, Obesity, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 session

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether electrical stimulation can help people with ankle instability improve their balance. Participants will walk on a treadmill in a virtual reality setting while receiving light electrical pulses to their legs. The main goal is to determine if these pulses can enhance balance, especially when the virtual reality environment changes suddenly. This trial might suit individuals who have experienced at least two ankle sprains, feel their ankle might give way, or worry about another sprain. As an unphased trial, this study offers a unique opportunity to explore innovative treatments for ankle instability.

Will I have to stop taking my current medications?

The trial requires that you do not take any medications affecting balance, such as certain antibiotics. If you are on such medications, you may need to stop taking them to participate.

What prior data suggests that this electrical stimulation technique is safe for improving balance in people with ankle instability?

Research has shown that a type of electrical stimulation called stochastic resonance (SR) is generally well-tolerated by people with ankle instability. Studies examining SR's effects on balance have found that it can help individuals stand and move more steadily, particularly those with ankle issues.

These studies have reported no major negative side effects from SR stimulation, suggesting it is a safe option for managing balance problems. Electrical stimulation, such as SR, is commonly used in therapy for various conditions and is considered safe for humans.

These findings provide some confidence in the safety of SR stimulation for improving balance. However, discussing any concerns with a healthcare provider before joining a trial is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Stochastic Resonance (SR) for ankle instability because it offers a novel approach to enhancing balance and stability. Unlike traditional treatments that focus on strengthening exercises or bracing, SR uses a unique method of electrical stimulation at an optimal intensity to improve sensory feedback and motor control. This technique could potentially provide immediate improvement in stability during movement, especially when visual cues are disrupted, setting it apart from current methods that often require longer periods to see results.

What evidence suggests that electrical stimulation is effective for improving balance in people with ankle instability?

Research has shown that mild electrical stimulation, known as stochastic resonance (SR), can help people with ankle instability improve their balance. In this trial, participants will either receive SR stimulation or no SR stimulation while walking on a treadmill. Studies have found that SR can help people stand steadily without wobbling. In one study, people with ankle instability had better balance when SR was used. Another review found that adding this type of electrotherapy to regular exercises led to better results. The gentle electrical stimulation helps the brain and muscles work together more effectively, improving balance control. ^{1 2 6 7 8}

Who Is on the Research Team?

John Jeka

Principal Investigator

University of Delaware

Are You a Good Fit for This Trial?

This trial is for individuals who have issues with ankle stability, possibly due to an injury or sprain. Participants should be able to walk on a treadmill and handle virtual reality environments. Specific eligibility details are not provided, but typically there would be age limits and health conditions that could exclude someone.

Inclusion Criteria

I had a severe ankle sprain in the last year that stopped my daily activities for a day.

I have ankle instability based on specific test scores.

I have sprained my ankle at least twice or feel it might give way.

Exclusion Criteria

I have no history of major neurological disorders.

My BMI is 30 or above, indicating obesity.

I have had issues with my balance or eyesight.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants walk on a treadmill in a virtual reality cave with and without electrical stimulation to assess balance

1 session

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Stochastic Resonance (SR)

Trial Overview The study tests if electrical stimulation (Stochastic Resonance) can improve balance in people with unstable ankles while they walk on a treadmill within a virtual reality setup designed to challenge their balance.

How Is the Trial Designed?

Group I: Stochastic Resonance (SR) Experimental Treatment 1 Intervention

During this condition, participants will walk on the treadmill while receiving SR stimulation at their individual optimal intensity (SR) with and without visual perturbations.

Group II: No Stochastic Resonance (no-SR) Active Control 1 Intervention

During this condition, participants will walk on the treadmill while receiving no SR stimulation (no-SR) with and without visual perturbations.

Stochastic Resonance (SR) is already approved in European Union, United States for the following indications:

Approved in European Union as FES/NMES for:

• Ankle instability
• Foot drop
• Muscle weakness

Approved in United States as FES/NMES for:

• Ankle instability
• Foot drop
• Muscle weakness

Who Is Running the Clinical Trial?

University of Delaware

Lead Sponsor

Trials

167

Recruited

25,700+

Published Research Related to This Trial

In a study involving 15 healthy subjects, low-amplitude stochastic vestibular electrical stimulation significantly improved balance performance by 5-26%, demonstrating the effectiveness of stochastic resonance in enhancing stability.

The optimal stimulation amplitude for improving balance was found to be between ±100 to ±400 μA, suggesting potential applications for a wearable device to assist individuals with balance issues due to aging or disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving balance function using vestibular stochastic resonance: optimizing stimulus characteristics. Mulavara, AP., Fiedler, MJ., Kofman, IS., et al.[2021]

A resistance training form of neuromuscular electrical stimulation (NMES) was successfully applied to individuals with motor complete spinal cord injury, leading to significant increases in muscle mass averaging 30% to 40% over 3 to 6 months of training.

Participants experienced no adverse events and showed consistent progress in their ability to perform more repetitions and lift heavier weights, indicating that NMES can effectively stimulate muscle growth and function even years after injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular Electrical Stimulation-Induced Resistance Training After SCI: A Review of the Dudley Protocol. Bickel, CS., Yarar-Fisher, C., Mahoney, ET., et al.[2018]

Stochastic resonance (SR) stimulation significantly improved postural stability in subjects with functional ankle instability (FAI), with optimal stimulation at 0.05 mA for most participants, leading to slower center-of-pressure velocities compared to control conditions.

The findings suggest that SR stimulation enhances the detection of sensorimotor signals, which could help reduce the risk of ankle sprains in individuals with a history of recurrent ankle instability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noise-enhanced postural stability in subjects with functional ankle instability. Ross, SE.[2022]

A single 10-minute session of functional electrical stimulation (FES) on the peroneal muscles improved ankle kinematics in healthy individuals, reducing excessive ankle inversion during walking, which is important for preventing re-injury.

The study involved 48 participants (24 with chronic ankle instability and 24 healthy controls), and while FES did not significantly change peroneal EMG activity, it showed potential for developing future treatments for individuals with chronic ankle instability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Immediate Carryover Effects of Peroneal Functional Electrical Stimulation Differ between People with and without Chronic Ankle Instability. Gottlieb, U., Hoffman, JR., Springer, S.[2022]

Stochastic resonance stimulation (SRS) significantly improved the accuracy and consistency of force sense in individuals with functional ankle instability, as shown by reduced absolute and variable errors during force reproduction tasks.

The study involved 24 participants (12 with functional ankle instability and 12 with stable ankles) and demonstrated that while SRS enhanced muscle tension ability, it did not affect the directionality of force sense errors, suggesting potential clinical benefits for ankle stability treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noise-Enhanced Eversion Force Sense in Ankles With or Without Functional Instability. Ross, SE., Linens, SW., Wright, CJ., et al.[2018]

In a study of 40 subjects with spinal cord injury and cerebral damage, functional electrical stimulation (FES) during walking led to an average improvement in walking speed of over 20%, with total gains reaching 45% over a year.

The largest improvements were observed in the slowest walkers, and the acceptance of FES systems was high, indicating a promising role for FES in treating gait disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter evaluation of electrical stimulation systems for walking. Wieler, M., Stein, RB., Ladouceur, M., et al.[2019]

Transcutaneous electrical nerve stimulation (TENS) improved reflexive excitability in the ankle muscles of patients with chronic ankle instability (CAI) after a 2-week intervention, indicating its potential for neuromodulation.

Despite the improvements in neural excitability observed with TENS, there were no significant changes in clinical function, suggesting that TENS alone may not be sufficient and could require additional rehabilitative exercises for lasting effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of neuromuscular electrical stimulation to the ankle pronators on neural excitability & functional status in patients with chronic ankle instability. Needle, AR., Tinsley, JE., Cash, JJ., et al.[2023]

Neuroprostheses (NPs) have evolved from early muscle stimulators to advanced devices that can effectively activate paralyzed muscles, with functional electrical stimulation (FES) showing significant benefits in enhancing muscle function, particularly in conditions like foot drop.

Recent advancements in technology have made these devices more convenient and reliable, leading to improved therapeutic outcomes, although challenges remain in enhancing upper limb function compared to lower limbs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor Neuroprostheses. Prochazka, A.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2465155/

Noise‐enhanced postural stability in subjects with ... Objective. To examine the effects of stochastic resonance (SR) stimulation on the postural stability of subjects with functional ankle instability (FAI).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06484712

Electrical Stimulation Effect on Ankle Instability During ... Interventional Model Description: Cross sectional study of responses to visual perturbations in one group, people with chronic ankle instability. Each ...

3. nata.kglmeridian.com nata.kglmeridian.com/view/journals/attr/aop/article-10.4085-1062-6050-0682.24/article-10.4085-1062-6050-0682.24.xml

Electrotherapy as a Rehabilitation Modality for Chronic Ankle ... The findings from the studies included in this review suggested that combining electrotherapy with TEx has preferable functional outcome measures than TEx ...

4. crd.york.ac.uk crd.york.ac.uk/prospero/display_record.php?ID=CRD42022328704

Citation 1 change Review objectives 1 change. To review the effectiveness of electrotherapy as a rehabilitation modality for ankle instability. Keywords 1 change.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2095254612000385

Noise-enhanced dynamic single leg balance in subjects ... A complimentary therapy known as stochastic resonance stimulation (SRS) can facilitate balance improvements immediately or more quickly than rehabilitation ...

6. researchgate.net researchgate.net/publication/382092108_Changes_in_Postural_Control_due_to_Electrical_Stimulation_Therapy_for_Ankle_Instability_A_Systematic_Review

Changes in Postural Control due to Electrical Stimulation ... Conclusion: These results suggest that ES interventions are crucial in enhancing postural control in subjects with ankle instability compared to ...

7. frontiersin.org frontiersin.org/journals/physiology/articles/10.3389/fphys.2018.01865/full

The Promise of Stochastic Resonance in Falls Prevention Stochastic resonance is a mechanism whereby a particular level of noise actually enhances the response of non-linear systems to weak sensory signals.

8. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-024-01462-2

Implications of neuromuscular electrical stimulation on gait ... This study aims to systematically review and summarize the evidence for the potential benefits of NMES on the improvement of gait patterns after stroke.