Clinical trial NCT06484712: Electrical Stimulation Effect on Ankle Instability During Walking in Virtual Reality Setup
Official title: The Role of Sensory Deficits in the Neural Control of Balance During Walking in People With Functional Ankle Instability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Sprains
Ankle Instability
Keywords: Chronic Ankle Instability
Electrical Stimulation
Virtual Reality
Balance
Locomotor Control
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Cross sectional study of responses to visual perturbations in one group, people with chronic ankle instability. Each participant will undergo two stimulation conditions, stochastic resonance (SR) stimulation and a control / no stochastic resonance (no-SR) condition while walking with and without visual perturbations.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in the Center of Mass (CoM) excursion
timeFrame: At the end of the session after 12 walking trials of randomized stimulation.
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: John Jeka
role: PRINCIPAL_INVESTIGATOR
References: