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临床试验/NCT06829342
NCT06829342已完成不适用

The Role of Sensory Deficits in the Neural Control of Balance During Walking in Parkinson's Disease

University of Delaware1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2021年5月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
1
主要终点
Change in the Center of Mass (CoM) excursion

研究概览

简要总结

The present study explored the use of a technique called stochastic resonance (SR) stimulation that may help individuals with Parkinson Disease maintain balance while walking on challenging surfaces. Impaired balance represents one of the disease symptoms, putting people at risk for falls, partly due to impaired processing of sensory information. SR uses light electrical signals to improve the way the body detects sensations. We wanted to test if SR could help people with Parkinson disease stay steadier while walking. Each participant's optimal SR intensity was determined before they walked on a treadmill in a virtual environment that created visual disturbances to challenge their balance. We measured how much their body swayed, how they placed their feet, and how their ankles moved during the walking tasks.

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
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Clinical diagnosis of Parkinson Disease
  • •Hoehn and Yahr (H&Y) stage ≤ III
  • •Can walk independently for at least 2 minutes without an assistive device or orthosis
  • •Ability to communicate discomfort during testing
  • •Can follow multi-step commands
  • •Scored at least 24/30 on the Montreal Cognitive assessment (MoCA)

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)
  • •Injuries to lower extremities affecting balance in the past six months
  • •Pregnancy
  • •Any neurological disorders other than Parkinson's disease (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
  • •Exhibited severe dyskinesia
  • •Did not respond to L-DOPA or other dopaminergic treatment
  • •Exhibited cardiovascular-autonomic or multiple-system symptoms indicative of a "Parkinsonism-plus" presentation

研究组 & 干预措施

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.

干预措施: Stochastic Resonance (SR) (Device)

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.

结局指标

主要结局

Change in the Center of Mass (CoM) excursion

时间窗: Through study completion, an average of 1 year.

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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