Electrical Stimulation Effect on Ankle Instability During Walking in Virtual Reality Setup

University of Delaware

Status: Completed

Conditions: Ankle Sprains; Ankle Instability

Treatments: Device: Stochastic Resonance (SR)

Study type: Interventional

Funder types: Other

Identifiers

NCT06484712

2182823-1

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 - 39 years.
• Having at least one significant ankle sprain in the past year, which causes a minimum of one interrupted day of physical activity.
• Having a history of at least two ankle sprains or "giving way" sensations at the injured ankle and/or a history of general feeling of ankle joint instability associated with the fear of getting another acute ankle sprain.
• Score < 24 in the Cumberland Ankle Instability Tool (CAIT), and/or > 11 in the Identification of Functional Ankle Instability (IdFAI), and/or answer ''yes'' to at least 5 yes/no questions in the Ankle Instability Instrument (AII).

Exclusion criteria

• Any head, neck, or face injury in the six months prior to the study (e.g., concussion, eye injury).
• History of vestibular or ocular dysfunction.
• Currently taking any medications affecting balance (i.e. antibiotics).
• History of injuries to lower extremities including fractures, knee injuries, and hip injuries.
• Sustaining an ankle sprain injury in the last 6 weeks.
• Pregnancy
• Any neurological disorders (e.g., seizure disorders, closed head injuries with loss of consciousness greater than 15 minutes, CNS neoplasm, history of stroke)
• Unstable cardiac or pulmonary disease.
• Clinically obese (BMI 30 or above).
• Any metal implant in the feet or legs that is close to the stimulating electrodes.
• A known allergy to medical-grade adhesives.
• Any other comorbidity affecting the ability to safely walk without assistance for at least 2 minutes

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Stochastic Resonance (SR)

Experimental group

Description:

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

Treatment:

Device: Stochastic Resonance (SR)

No Stochastic Resonance (no-SR)

No Intervention group

Description:

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