The Role of Sensory Deficits in the Neural Control of Balance During Walking in People With Functional Ankle Instability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in the Center of Mass (CoM) excursion
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
结局指标
主要结局
Change in the Center of Mass (CoM) excursion
时间窗: 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.
次要结局
未报告次要终点