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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06484712
Enrollment
32
Registered
2024-07-03
Start date
2024-05-29
Completion date
2025-01-09
Last updated
2025-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Instability, Ankle Sprains

Keywords

Chronic Ankle Instability, Electrical Stimulation, Virtual Reality, Balance, Locomotor Control

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.

Interventions

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.

Sponsors

University of Delaware
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in the Center of Mass (CoM) excursionAt 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026