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

Completed · Not applicable

Conditions studied: Ankle Sprains, Ankle Instability

In brief

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.

Key facts

Study ID

NCT06484712

Run by

University of Delaware

People needed

32

Starts

2024-05-29

Expected to finish

2025-01-09

Last updated by the study team

2025-04-11

Who can join

Age: 18 and older, up to 39. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• University of Delaware — Newark, Delaware, United States

Full record on ClinicalTrials.gov

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