NCT07522827

Foot And Ankle Proprıoceptıve Exercıse Program

Effect Of Foot And Ankle Proprioceptive Exercise Program On Physical Performance, Foot Posture And Falls in Geriatric Individuals

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Ankara University · Academic / Other
• Sex: All
• Age: 65 Years – 100 Years
• Healthy volunteers: Accepted

Summary

This study will be conducted to evaluate whether the foot and ankle proprioceptive exercise program contributes to foot posture, physical performance and fall incidence in geriatric individuals. Through this research, as a result of physiological changes that occur as age increases, foot posture and physical performance in geriatric individuals are negatively affected, and the incidence of falls increases, causing injuries. It is expected to achieve changes in foot posture, physical performance and fall incidence with the foot and ankle proprioceptive exercise program in geriatric individuals.

Detailed description

Participants will be divided into two groups: an intervention (exercise) group and a control group. Based on the assumption that the difference in pre- and post-intervention changes between groups will be significantly in favor of the intervention group (effect size: Cohen's d = 0.80), a power analysis was conducted using Student's t-test with a Type I error rate of 5% and a power of 80%. The study by Mat et al., conducted on geriatric individuals, was used as a reference in the literature (8). The required number of participants was calculated as 17 for the intervention group and 18 for the control group. Considering the high risk of mortality and morbidity in the elderly population, the study is planned to be carried out with 20 participants in the intervention group and 20 in the control group to account for potential attrition. Group randomization will be based on stratification by gender and age, as these factors are considered likely to affect fall risk in the geriatric population. Participants included in the study sample will be stratified according to these two criteria. Additionally, each participant will be assigned a unique identification number. Data collection will be conducted face-to-face. The data will be collected by Assoc. Prof. Bahar Külünkoğlu and Ayşegül Atlı. Demographic Information Descriptive data including participants' age, gender, weight, height, Body Mass Index (BMI), education level, medications used, medical history, family history, marital status, history of falls, and fall-related injuries will be collected using a sociodemographic form. Cognitive Assessment Standardized Mini Mental State Examination (MMSE): This test will be used to assess cognitive functions and to determine the suitability of individuals for participation in the study. Developed by Folstein et al. (9) and validated in Turkish by Güngen et al. in 2005 , the MMSE scores are interpreted as follows: 28-30: Normal cognitive function 24-27: Mild cognitive impairment 0-23: Significant cognitive impairment Foot Posture Assessment The following measurements will be performed: Navicular Drop Test Metatarsal Width Foot Length Navicular Drop Test: This test assesses the degree of pronation in the foot by calculating the difference in navicular height between non-weight-bearing and weight-bearing positions. Participants will be seated barefoot while the navicular tuberosity is marked. The same mark will be recorded on a card placed on the floor. Then, participants will stand up with full weight bearing, and the new mark will be recorded. The distance (in mm) between the two marks is recorded as the navicular drop . Metatarsal Width: Using a digital caliper, the distance between the medial and lateral heads of the metatarsals will be measured with slight compression. Foot Length: Foot length will be measured as the distance between the tip of the longest toe and the most posterior part of the heel using a measuring tape. Physical Performance Assessment Short Physical Performance Battery (SPPB): This battery evaluates physical and functional health in older adults, particularly those living in nursing homes. It consists of three objective tests: 4-meter walk test, chair stand test, and balance tests. Scoring: 4-meter walk: 8.70 seconds = 1 point 6.21-8.70 seconds = 2 points 4.82-6.20 seconds = 3 points \<4.82 seconds = 4 points Chair stand: ≥16.7 seconds = 1 point 13.7-16.6 seconds = 2 points 11.2-13.6 seconds = 3 points \<11.2 seconds = 4 points Balance tests: Side-by-side and semi-tandem stance: Stand for 10 seconds = 1 point Unable to stand for 10 seconds = 0 points Tandem stance: ≥10 seconds = 2 points 3-9 seconds = 1 point \<3 seconds = 0 points Fear of Falling Assessment Falls Efficacy Scale-International (FES-I): Developed by Yardley et al., the FES-I measures fear of falling during activities of daily living. It consists of 16 items, each rated on a 4-point Likert scale: 1. = Not at all concerned 2. = Somewhat concerned 3. = Fairly concerned 4. = Very concerned Total scores range from 16 (no fear) to 64 (severe fear). According to Delbaere et al. , score ranges are categorized as:16-19: Low concern 20-27: Moderate concern 28-64: High concern The Turkish validity and reliability study was conducted by Ulus et al. Plantar Sensation Assessment Semmes-Weinstein Monofilament Test: This test evaluates light touch and pressure thresholds by determining the minimal stimulus required to depolarize cell membranes. Sensation at 9 plantar regions (heel, medial midfoot, lateral midfoot, heads of the 1st, 3rd, and 5th metatarsals, and tips of the 1st, 3rd, and 5th toes) will be assessed. Participants will be tested first with eyes open, then closed. Upon sensing contact, they will be asked to respond verbally. Testing will start with the thinnest monofilament and progress to thicker ones. Each filament will be applied three times per site for 2 seconds at a perpendicular angle until it bends. Interpretation of Monofilament Numbers: Monofilament No. Interpretation 2.36-2.83 Normal 3.22-3.61 Decreased light touch 3.84-4.31 Decreased protective sensation 4.56-6.65 Loss of protective sensation No response No sensation Ankle Proprioception Assessment Joint Position Reproduction Test: Participants will be seated with hips and knees at 90° flexion. The target joint angles are 10° dorsiflexion and 20° plantar flexion. The evaluator will demonstrate the angle using a goniometer, and participants will attempt to replicate the angle. The test will be repeated three times, and the mean value will be recorded. Exercise Program A specially designed foot and ankle proprioceptive exercise program will be implemented. The intervention will consist of 24 sessions over 8 weeks (3 days per week). Exercises will be performed in groups of five participants under the supervision of a physiotherapist in the exercise room of the nursing home. The exercises are tailored to the elderly population, focusing on low to moderate intensity to ensure accessibility and safety. Intervention Group: In addition to their routine physiotherapy, participants will perform foot and ankle proprioceptive exercises. Control Group: Will continue only with their standard physiotherapy program, which includes strength, balance, and posture training-but not proprioceptive exercises or study-specific materials. Assessments will be conducted at baseline, post-intervention, and 3 months after the intervention. Each session will include 10 minutes of warm-up and cool-down exercises. Safety measures will be taken throughout the program. Since all exercises are performed in a seated position, the program is designed to avoid excessive stress on the participants' vital functions. Each exercise will be performed as one set of 10 repetitions, with each repetition lasting 5 seconds. A rest period of 45 seconds will be provided between sets. After the final (3rd month) evaluation, the control group will also be offered the opportunity to participate in the same proprioceptive training. The exercises will be conducted using spiky balls and spiky balance balls in a seated position.

Conditions

• Geriatric
• Foot Ankle Injuries
• Exercise
• Fall in Nursing Home

Interventions

Type	Name	Description
OTHER	home exercise	group receives a home program.
OTHER	Foot and ankle proprioceptive exercise	Foot and ankle proprioceptive exercises will be performed only while seated. This is because, in geriatric individuals at risk of falling, the aim is to reduce the risk of falls by conducting exercises in a safe environment.

Timeline

• Start date: 2023-01-24
• Primary completion: 2024-06-10
• Completion: 2024-06-15
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: Turkey (Türkiye)