The Effects of Intrinsic Foot Muscle Strengthening Interventions on Balance, Proprioception, Foot Structure, and Fall Risk in Adults Over Age 65
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in Mini BesTest scores
研究概览
简要总结
Falls are the leading cause of injury in adults over age 65. Muscle weakness in the foot can lead to foot and toe deformities such as collapsed arches or bunions, which have been found to contribute to falls in adults over age 65. The current research study aims to investigate the effectiveness of two simple and affordable foot strengthening methods that may make a major impact on balance and fall prevention in older adults.
详细描述
Background: Falls are the leading cause of injury in adults 65 years and older. While causes of falls are multifactorial, foot function plays a vital role. The intrinsic foot muscles (IFM), those that originate and insert within the foot, provide stability and sensory input important for balance. Weakness or disuse of the IFM in older adults can contribute to faulty foot and toe alignment, which have been cited as independent predictors of falls. Wearing minimally cushioned footwear or performing strengthening exercises that target the IFM may improve these muscles' strength, endurance, proprioceptive qualities, and foot/toe structure, which may improve functional mobility and balance in older adults, and thus, prevent falls.
Purpose: The purpose of the proposed research is to analyze the effects of two IFM strengthening interventions (minimal footwear use or strengthening exercises) on IFM strength, proprioception, foot/toe structure, balance and functional mobility, and fall risk in older adults.
Design: Randomized control trial with an effectiveness-implementation hybrid design Type I
Methods: Adults ages > 65 years who can ambulate household distances with or without an assistive device who are determined to be at risk for falls will be invited to participate. Individuals with poor foot sensation, vestibular disorders, lower extremity amputation, injury or surgery to the lower extremities or lumbar spine in the previous 6 months, impaired cognitive ability to follow verbal and written instructions, and those who have participated in a fall prevention program in the past 6 months will be excluded. Following informed consent and initial screening, participants will be randomly allocated to one of three intervention groups (n=90, 30/group):
- intrinsic foot muscle strengthening exercises
- minimal footwear prescribed walking
- control (will receive a fall prevention brochure and seated active motion exercises)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants are unable to be blinded to treatment they are receiving, but they will not be told interventions of other groups.
Investigators who perform measurements are blinded to intervention group.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Can ambulate household distances (16 meters) with or without an assistive device
- •Have fall risk based on a "yes" to any of the Three Key Questions Do you feel unsteady when standing or walking? Do you worry about falling? Have you fallen in the past year? OR
- •Have a fall risk based on Timed Up and Go score (> 12 seconds)
排除标准
- •poor foot sensation (Semmes-Weinstein)
- •lower extremity amputations
- •lumbar spine or lower extremity injury or surgery in the past 6 months
- •impaired cognitive ability to follow verbal or written instructions (MMSE)
- •vestibular disorders
- •based on self-report and/or the Vestibular Screening Tool (score > 4)
- •participation in a fall prevention program in the previous 6 months
结局指标
主要结局
Change in Mini BesTest scores
时间窗: 1 year post intervention
a comprehensive measure of balance, gait, and functional mobility (max score 28 and indicates good balance/mobility and low fall risk)
Change in intrinsic foot muscle cross-sectional area/strength
时间窗: 1 year post intervention
real-time ultrasound imaging will measure muscle size (cross-sectional area) of the abductor hallucis, flexor hallucis brevis, flexor digitorum brevis, quadratus plantae, and abductor digiti minimi muscles of the right foot
次要结局
- Change in navicular drop measure(1 year post intervention)
- Change in proprioception measure(1 year post intervention)
- Change in hallux valgus angle(1 year post intervention)