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

32 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to investigate whether electrical stimulation to leg muscles and joints can help with balance in people with ankle instability. Participants will be asked to walk on a treadmill in a virtual reality cave. They will receive light electrical stimulation at the legs to improve your balance. The virtual reality image will sometimes shift in unexpected ways to challenge your balance. During the session, we will conduct a series of clinical assessments, including tests of functional performance and balance. Additionally, participants will be asked to fill out some questionnaires.

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 data supports the effectiveness of the treatment for ankle instability?

Research shows that stochastic resonance (SR) stimulation can improve balance and postural stability, which may help people with ankle instability. Additionally, neuromuscular electrical stimulation (NMES) has been found to enhance neural function and performance in those with chronic ankle instability. ^{1 2 3 4 5}

Is electrical stimulation safe for humans?

Electrical stimulation techniques like Stochastic Resonance (SR), Functional Electrical Stimulation (FES), and Neuromuscular Electrical Stimulation (NMES) have been used safely in humans for various conditions, including improving balance and muscle function. These methods have been applied in both healthy individuals and those with conditions like spinal cord injury, showing benefits without significant safety concerns. ^{2 3 6 7 8}

How is the treatment Stochastic Resonance (SR) different from other treatments for ankle instability?

Stochastic Resonance (SR) is unique because it uses electrical stimulation to enhance the body's natural balance and stability mechanisms by introducing a specific level of noise to improve sensory responses. This approach is different from traditional treatments as it directly targets and optimizes the neuromuscular system's response to improve balance and reduce the risk of re-injury. ^{1 2 3 4 7}

Research Team

John Jeka

Principal Investigator

University of Delaware

Eligibility Criteria

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 not had a head, neck, or face injury in the last 6 months.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Improving balance function using vestibular stochastic resonance: optimizing stimulus characteristics. [2021]

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

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

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

Noise-Enhanced Eversion Force Sense in Ankles With or Without Functional Instability. [2018]

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

Multicenter evaluation of electrical stimulation systems for walking. [2019]

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

Motor Neuroprostheses. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

The Immediate Carryover Effects of Peroneal Functional Electrical Stimulation Differ between People with and without Chronic Ankle Instability. [2022]

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

Neuromuscular Electrical Stimulation-Induced Resistance Training After SCI: A Review of the Dudley Protocol. [2018]