Evaluation of a Novel Foot Strengthening Device for Improving Fall Risk, Balance, and Gait With Age
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Change From Baseline in Hallux Flexion Strength (Curl)
研究概览
简要总结
The goal of this clinical trial is to learn whether different foot-strengthening strategies can improve foot strength, balance, walking ability, and fall-related outcomes in middle-aged and older adults (ages 45-85 years).
The main questions it aims to answer are:
- Does foot strength change from baseline after an 8-week foot-strengthening intervention?
- Do balance, gait, and physical function improve following different foot-strengthening approaches?
Researchers will compare minimalist footwear use, a foot exercise program, a foot-strengthening device (ToePro), and no intervention to see if these interventions lead to greater improvements in foot strength, balance, gait, and fall-related outcomes than no intervention.
Participants will:
- Complete baseline and post-intervention laboratory testing of foot strength, balance, physical function, and walking gait
- Perform foot strengthening exercises or wear minimalist footwear (if applicable) five days/week for eight weeks
- Complete daily logs to record intervention compliance
详细描述
This randomized controlled trial evaluates the effects of multiple foot-strengthening interventions on foot strength, balance, gait, and fall-related outcomes in older adults. Participants are recruited using a unified screening process and randomized to one of several intervention arms across two coordinated protocols. Interventions include habitual use of minimalist footwear, a prescribed foot exercise program, use of a commercially available foot-strengthening device (ToePro), or a no-intervention control condition.
All participants complete two in-laboratory data collection sessions conducted at baseline and after an 8-week intervention period. Laboratory assessments include measurements of foot morphology, intrinsic and extrinsic foot muscle strength, standing balance, physical function, and walking gait. Participants also complete standardized questionnaires assessing physical activity, balance confidence, fall history, and foot health. A follow-up questionnaire assessing physical activity, footwear use, foot health, and falls is administered six months after the intervention period.
During the 8-week intervention period, participants assigned to an active intervention are instructed to follow standardized intervention protocols specific to their assigned group. Physical activity levels during the intervention period are monitored for all groups using wearable activity tracking devices that record metrics such as daily step count and time spent in moderate-to-vigorous physical activity. These data are used to characterize habitual physical activity during the intervention period and to account for potential differences in overall activity levels between groups.
Intervention compliance is monitored throughout the 8-week period using self-reported compliance surveys. Participants report adherence to assigned footwear use, exercise sessions, or device use according to their intervention group. Compliance data are used to quantify adherence to the prescribed intervention protocols and to support interpretation of intervention effects.
Data from both protocols are pooled to allow direct comparison of the effects of different foot-strengthening strategies on foot strength, balance, gait, and fall-related outcomes in middle-aged and older adults.
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
- None
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults: 45 years of age or older
- •Able to walk without an assistive walking device or lower limb prosthesis for at least 6 minutes
- •No history of foot or ankle surgery
- •No history of regular minimalist footwear use
- •No foot or ankle issues for which study activities may be contraindicated
- •BMI <= 40
排除标准
- •Deemed unfit for physical activity by the Physical Activity Readiness Questionnaire (PAR-Q)
- •Current or history of an unresolved musculoskeletal, neurological, cardiovascular, pulmonary/respiratory, metabolic, renal condition, disease, or problem
- •Use of orthotics in daily (i.e., non-athletic) footwear
- •Pregnancy
- •Any other disease or problems that may affect movement or the ability to exercise even at a low intensity
研究组 & 干预措施
Foot exercise program
Participants complete a prescribed foot and ankle strengthening exercise program targeting intrinsic and extrinsic foot muscles over an 8-week period.
干预措施: Foot strengthening exercises (Behavioral)
Minimalist footwear
Participants are instructed to wear minimalist footwear during activities of daily living for 8 weeks, progressively increasing wear time according to a standardized schedule.
干预措施: Minimalist footwear (Device)
Control
Participants do not receive any foot-strengthening intervention and continue usual activities.
Foot strengthening device (ToePro)
Participants use a commercially available foot-strengthening device (ToePro) for a prescribed exercise protocol over 8 weeks.
干预措施: ToePro foot strengthening device (Device)
结局指标
主要结局
Change From Baseline in Hallux Flexion Strength (Curl)
时间窗: From enrollment to the end of the intervention at 8 weeks
Change in maximal hallux (big toe) flexion strength assessed using a standardized hallux curl test (i.e., flexion at the metatarsal interphalangeal joints) with a dynamometer. Participants perform brief maximal voluntary contractions, and peak force output is recorded. Higher values indicate greater hallux curl strength.
Change From Baseline in Lesser Toes Flexion Strength (Curl)
时间窗: From enrollment to the end of the intervention at 8 weeks
Change in maximal lesser toes flexion strength assessed using a standardized lesser toes curl test (i.e., flexion at the metatarsal interphalangeal joints) with a dynamometer. Participants perform brief maximal voluntary contractions, and peak force output is recorded. Higher values indicate greater lesser toes curl strength.
Change From Baseline in Hallux Flexion Strength (Press)
时间窗: From enrollment to the end of the intervention at 8 weeks
Change in maximal hallux flexion strength assessed using a toe press test that isolates hallux flexion at the metatarsophalangeal joint. Strength is measured using a force-instrumented platform, with higher values indicating greater hallux press strength.
Change From Baseline in Lesser Toe Flexion Strength (Press)
时间窗: From enrollment to the end of the intervention at 8 weeks
Change in maximal lesser toes flexion strength assessed using a toe press test that isolates flexion at the metatarsophalangeal joints. Strength is measured using a force-instrumented platform, with higher values indicating greater lesser toes press strength.
Change From Baseline in Gait Kinetic Variables
时间窗: From enrollment to the end of the intervention at 8 weeks
Change in gait kinetic variables derived from motion capture and force measurement systems during walking. Measures include ground reaction force variables such as peak vertical force. Values reflect loading patterns during gait.
Change From Baseline in Joint Angles during Gait
时间窗: From enrollment to the end of the intervention at 8 weeks
Change in lower-limb and foot joint angles measured during walking using motion capture. Joint angles are calculated across the gait cycle and represent segmental motion of the foot and lower extremity.
Change From Baseline in Joint Range of Motion During Gait
时间窗: From enrollment to the end of the intervention at 8 weeks
Change in joint range of motion (ROM) of the foot and lower extremity measured during walking using motion capture. ROM is calculated as the difference between maximum and minimum joint angles during the gait cycle.
Change From Baseline in Stance Time During Gait
时间窗: From enrollment to the end of the intervention at 8 weeks
Change in stance time measured during walking using motion capture. Stance time represents the duration the foot remains in contact with the ground during each gait cycle.
Change From Baseline in Step Length During Gait
时间窗: From enrollment to the end of the intervention at 8 weeks
Change in step length measured during walking using motion capture. Step length is defined as the anterior-posterior distance between successive foot contacts.
Change From Baseline in Cadence During Gait
时间窗: From enrollment to the end of the intervention at 8 weeks
Change in walking cadence measured during gait analysis using motion capture. Cadence is expressed as steps per minute.
Change From Baseline in Step Width During Gait
时间窗: From enrollment to the end of the intervention at 8 weeks
Change in step width measured during walking using motion capture. Step width reflects the mediolateral distance between foot placements and is used as an indicator of gait stability.
Change From Baseline in 6-Minute Walk Test Distance
时间窗: From enrollment to the end of the intervention at 8 weeks
Change in distance walked during the 6-Minute Walk Test (6MWT), measured in meters. Greater distance indicates better functional walking capacity.
Change From Baseline in 30-Second Sit-to-Stand Test Performance
时间窗: From enrollment to the end of the intervention at 8 weeks
Change in functional lower-extremity performance assessed using the 30-Second Sit-to-Stand Test. Outcomes include the total number of completed sit-to-stand repetitions, with higher values indicating better performance.
Change From Baseline in 4-Stage Balance Test Performance
时间窗: From enrollment to the end of the intervention at 8 weeks
Change in standing balance performance assessed using the 4-Stage Balance Test. Outcomes include the ability to successfully complete progressively challenging standing positions for the required duration.
Change From Baseline in Single-Leg Heel-Raise Test Performance
时间窗: From enrollment to the end of the intervention at 8 weeks
Change in plantar flexor endurance assessed using the single-leg heel-raise test. Outcomes include the number of consecutive heel raises completed with proper form, with higher values indicating greater muscular endurance.
次要结局
- Change From Baseline in IMU-Derived Gait Acceleration Magnitude(From enrollment to the end of the intervention at 8 weeks)
- Footwear Minimalism (Minimalist Index)(Baseline)
- Intervention Compliance Survey Responses(Throughout the 8-week intervention period)
- FitBit-Derived Moderate-to-Vigorous Physical Activity (MVPA)(Throughout the 8-week intervention period)
- Change From Baseline in International Physical Activity Questionnaire (IPAQ) Scores(From enrollment to the end of the intervention at 8 weeks)
- Change From Baseline in Sedentary Behavior Questionnaire (SBQ) Scores(From enrollment to the end of the intervention at 8 weeks)
研究者
Allison Gruber, PhD
Associate Professor
Indiana University