Ankle SprainsNCT06484712
Electrical Stimulation Effect on Ankle Instability During Walking in Virtual Reality Setup
A study testing Stochastic Resonance (SR) in people with Ankle Sprains and Ankle Instability, run by University of Delaware at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Ankle Sprains, Ankle Instability
- What is being tested?
- Stochastic Resonance (SR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2024to 9 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Sensory Deficits in the Neural Control of Balance During Walking in People With Functional Ankle Instability
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.
- Conditions
- Ankle Sprains, Ankle Instability
- Being tested
- Stochastic Resonance (SR)
- Keywords
- Chronic Ankle Instability, Electrical Stimulation, Virtual Reality, Balance, Locomotor Control
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Stochastic Resonance (SR) | Experimental | During this condition, participants will walk on the treadmill while receiving SR stimulation at their individual optimal intensity (SR) with and without visual perturbations. Receives: Device: Stochastic Resonance (SR) |
| No Stochastic Resonance (no-SR) | No intervention | During this condition, participants will walk on the treadmill while receiving no SR stimulation (no-SR) with and without visual perturbations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Center of Mass (CoM) excursion
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.
Measured: At the end of the session after 12 walking trials of randomized stimulation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start29 May 2024
- Primary completion9 Jan 2025
- Study completion9 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankle SprainsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Jeka, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484712
- Sponsor's protocol ID
- 2182823-1
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alsaqabi E, Verma K, Jeka J. Stochastic Resonance Stimulation Improves Postural Stability in People with Chronic Ankle Instability During Walking. J Mot Behav. 2026;58(2):253-265. doi: 10.1080/00222895.2026.2637944. Epub 2026 Mar 17.
PubMed 41841619
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Sensory Deficits in the Neural Control of Balance During Walking in People With Functional Ankle Instability
- ClinicalTrials.gov ID
- NCT06484712
- Acronym / sponsor ID
- 2182823-1
- Conditions
- Ankle Sprains, Ankle Instability
- Keywords
- Chronic Ankle Instability, Electrical Stimulation, Virtual Reality, Balance, Locomotor Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 29 May 2024 (actual)
- Primary completion
- 9 Jan 2025 (actual)
- Study completion
- 9 Jan 2025 (actual)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Stochastic Resonance (SR) | Experimental | Device: Stochastic Resonance (SR)During this condition, participants will walk on the treadmill while receiving SR stimulation at their individual optimal intensity (SR) with and without visual perturbations. |
| No Stochastic Resonance (no-SR) | No intervention | –During this condition, participants will walk on the treadmill while receiving no SR stimulation (no-SR) with and without visual perturbations. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stochastic Resonance (SR)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. | Device | Stochastic Resonance (SR) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Derived from this study: PubMed 41841619Alsaqabi E, Verma K, Jeka J. Stochastic Resonance Stimulation Improves Postural Stability in People with Chronic Ankle Instability During Walking. J Mot Behav. 2026;58(2):253-265. doi: 10.1080/00222895.2026.2637944. Epub 2026 Mar 17.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Jeka principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stochastic Resonance (SR) in people with Ankle Sprains and Ankle Instability, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Center of Mass (CoM) excursion (time frame: At the end of the session after 12 walking trials of randomized stimulation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06484712, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.