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

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.

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Key information

Conditions

Ankle Sprains Ankle Injuries Ankle Instability Leg Injuries Wounds and Injuries

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Delaware

Newark, Delaware, 19713, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stochastic Resonance (SR)

Device

The system consists of six linear isolated stimulators (STMISOLA, Biopac Systems, Inc., Goleta, USA). The SR signal (Gaussian White Noise, zero mean) will be generated through a 16 bit PCI 6733 National Instruments multifunction data acquisition card by a custom LabView program. The stimulation sites include the ankle, lateral soleus, peroneus longus, and tibialis anterior muscles and the hip.

Primary outcomes

Change in the Center of Mass (CoM) excursion

Time frame: At the end of the session after 12 walking trials of randomized stimulation.

For the visual perturbation trials, we will use CoM excursion as the primary outcome measure since it has been used in prior studies in children and adults using visual perturbation protocols. This is determined by comparing the average CoM during perturbed steps to non-perturbed steps for each participant, integrated across the first eight steps initiated by the heel strike that triggered the stimulus. We will measure CoM using kinetics and kinematic computed through a motion capture system(Qualysis).

For the unperturbed trials, we will use margin of stability (MoS) as the primary outcome measure. MOS refers to the distance between extrapolated center of mass, which includes center of mass position and velocity, and the base of support. It has been previously used to measure balance in children with cerebral palsy and Parkinson Disease.

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Registry information

Official study title

The Role of Sensory Deficits in the Neural Control of Balance During Walking in People With Functional Ankle Instability

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jul 3, 2024
Registry last updated: Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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