Cortical Mechanisms and Modulation of Somatosensation in Older Adults With Foot Sole Somatosensory Impairments
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- postural sway area when standing with eyes closed on the foam
研究概览
简要总结
In older adults, diminished sensation of the legs and feet is highly prevalent and causes poor balance and reduced mobility. This type of sensation is not only dependent upon the receptors and nerves in the legs and feet, but also upon a complex central nervous system pathway that includes the cerebral cortex of the brain. This project will use a form of noninvasive brain stimulation called transcranial direct current stimulation (tDCS) to test whether increasing the excitability of the brain networks that process sensory feedback can augment foot sole sensation, balance, and mobility in older adults suffering from mild-to-moderate foot sole sensory impairments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥65 years.
- •Self-reported feeling of unsteadiness or difficulty when standing and walking.
- •Mild-to-moderate foot-sole somatosensory impairment: the ability to perceive 75g monofilament but inability to perceive 10g monofilament.
排除标准
- •self-reported inability to stand or walk continuously for one minute without personal assistance (canes or walkers allowed);
- •history or presence of foot ulceration, amputation, or deformities;
- •self-reported uncontrolled pain or pain that is associated with mobility disability;
- •uncontrolled diabetes mellitus;
- •hospitalization within the past three months due to acute illness, or as the result of a musculoskeletal injury significantly affecting balance;
- •persistent severe pain of lower extremity when standing or walking;
- •diagnosis of dementia, Parkinson's disease, or stroke that affects balance;
- •unstable medical condition;
- •legal blindness or deafness;
- •uncontrolled hypertension (i.e., systolic BP >180, diastolic BP >100 mm Hg, or prescription of ≥3 anti-hypertensive medications);
- •functionally limiting nephropathy, severe diseases or transplant of the kidney or liver, renal or congestive heart failure;
- •active cancer treatment;
- •balance disorders due to past use of chemotherapy or history of Guillain-Barré syndrome;
- •use of neuro-active or recreational drugs (e.g., sedatives, anti-psychotics), or alcohol abuse, which may affect the brain excitability;
- •contraindications to MRI or tDCS (e.g., personal or family history of seizures or epilepsy, metallic or electric bio-implants, claustrophobia, brain surgery);
- •persistent vertigo;
- •history of Charcot-Marie-Tooth nerve disease.
研究组 & 干预措施
tDCS group
Participants in this arm will receive the real tDCS intervention.
干预措施: transcranial direct current stimulation (Device)
sham group
Participants in this arm will receive the sham stimulation as control.
干预措施: active sham stimulation (Device)
结局指标
主要结局
postural sway area when standing with eyes closed on the foam
时间窗: Before and immediately after intervention
This metric assesses the degree to which the soft support and cut-off of the vision diminishes the control of standing posture.
Standing vibratory thresholds of each foot sole
时间窗: Before and immediately after intervention
This metric assesses the degree to which the foot soles can sense the vibro-tactile stimuli when standing.
postural sway area when standing with eyes closed on the foam
时间窗: Before and immediately after intervention
This metric assesses the degree to which the soft support and cut-off of the vision diminishes the control of standing posture.
Timed Up-and-Go (TUG) time
时间窗: Before and immediately after intervention
This metric assesses mobility.
On-target Blood oxygen level dependent (BOLD) signal intensity in response to foot sole stimulation
时间窗: Before and immediately after intervention
This metric assesses the degree to which brain cortical regions activated by the walking-related foot-sole stimulation.
Standing vibratory thresholds of each foot sole
时间窗: Before and immediately after intervention
This metric assesses the degree to which the foot soles can sense the vibro-tactile stimuli when standing.
次要结局
- Gait speed of 10m walking test(Before and immediately after intervention)
- Postural sway speed when standing with eyes closed on the foam(Before and immediately after intervention)