GeriatricNCT07522827
Foot And Ankle Proprıoceptıve Exercıse Program
A study testing home exercise and Foot and ankle proprioceptive exercise in people with Geriatric and Foot Ankle Injuries, run by Ankara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Geriatric, Foot Ankle Injuries, Exercise
- What is being tested?
- home exercise and Foot and ankle proprioceptive exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jan 2023to 15 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Individuals aged 65 years and older
- A score of 24 or higher on the Standardized Mini-Mental State Examination (MMSE)
- Ability to read and write in Turkish
- Voluntary participation in the study with signed informed consent
- Ability to stand independently and take at least two steps without assistance
- Ability to walk independently in the community without the use of lower extremity orthoses or
Who cannot join
- Uncorrected visual impairments that cannot be resolved with glasses
- Uncorrected hearing loss despite the use of hearing aids
- A score of 23 or below on the Mini-Mental State Examination
- Any surgical procedure affecting balance within the last 6 months
- Presence of deformities in the lumbar spine, hip, or knee joints
- Lower extremity amputation
Show all 10Show fewer
- Malignancy involving the lower extremities
- Diagnosis of moderate to severe congenital heart disease, coronary artery disease, or cerebrovascular disease
- Any medical contraindications to exercise
- Inability to establish cooperation with the participant
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University, Haymana Vocational School
Ankara, Haymana
About this study
Official title: Effect Of Foot And Ankle Proprioceptive Exercise Program On Physical Performance, Foot Posture And Falls in Geriatric Individuals
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.
Read the 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:
- = Not at all concerned
- = Somewhat concerned
- = Fairly concerned
- = 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
- Being tested
- home exercise, Foot and ankle proprioceptive exercise
- Keywords
- geriatric, foot, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home exerciseOther
group receives a home program.
Foot and ankle proprioceptive exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Due to the high risk of mortality and morbidity associated with the elderly population, it is planned that the study will be conducted with 20 participants in the intervention group and 20 participants in the control group. For group randomization, stratification will be based on age and gender, as these factors are considered potential influencers of fall risk among geriatric individuals included in the sample. Participants in each study group will be stratified according to these two criteria. In addition, each participant will be assigned a unique identification number for tracking and confidentiality purposes. Receives: Other: Foot and ankle proprioceptive exercise |
| control grup | Experimental | The control group will only receive the home program. Receives: Other: home exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Performance
Short Physical Performance Battery (SPPB)
Measured: Baseline, 8 weeks (Post-intervention), and 3 months (Follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start24 Jan 2023
- Primary completion10 Jun 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GeriatricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysegul Atli, Ankara University
- Investigators
- bahar anaforoğlu, prof, Study director, bidb@aybu.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522827
- Sponsor's protocol ID
- AU-ATLI-054
- Status last verified
- Mar 2026
- First submitted
- 17 Jul 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Foot And Ankle Proprioceptive Exercise Program On Physical Performance, Foot Posture And Falls in Geriatric Individuals
- ClinicalTrials.gov ID
- NCT07522827
- Acronym / sponsor ID
- AU-ATLI-054
- Conditions
- Geriatric, Foot Ankle Injuries, Exercise, Fall in Nursing Home
- Keywords
- geriatric, foot, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- = Not at all concerned
- = Somewhat concerned
- = Fairly concerned
- = 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Foot and ankle proprioceptive exerciseDue to the high risk of mortality and morbidity associated with the elderly population, it is planned that the study will be conducted with 20 participants in the intervention group and 20 participants in the control group. For group randomization, stratification will be based on age and gender, as these factors are considered potential influencers of fall risk among geriatric individuals included in the sample. Participants in each study group will be stratified according to these two criteria. In addition, each participant will be assigned a unique identification number for tracking and confidentiality purposes. |
| control grup | Experimental | Other: home exerciseThe control group will only receive the home program. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Individuals aged 65 years and older
- A score of 24 or higher on the Standardized Mini-Mental State Examination (MMSE)
- Ability to read and write in Turkish
- Voluntary participation in the study with signed informed consent
- Ability to stand independently and take at least two steps without assistance
Key exclusion criteria (10 listed)
- Uncorrected visual impairments that cannot be resolved with glasses
- Uncorrected hearing loss despite the use of hearing aids
- A score of 23 or below on the Mini-Mental State Examination
- Any surgical procedure affecting balance within the last 6 months
- Presence of deformities in the lumbar spine, hip, or knee joints
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| home exercisegroup receives a home program. | Other | control grup |
| Foot and ankle proprioceptive exerciseFoot 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. | Other | Intervention group |
Primary outcome
Physical Performance
Time frame: Baseline, 8 weeks (Post-intervention), and 3 months (Follow-up).
Short Physical Performance Battery (SPPB)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Geriatric
Not yet recruitingObservational study
Dynamic Inflammatory Changes and Nutritional Risk Scores in ICU Patients Aged 65 Years and Older
Critical Illness, Geriatric Patient
Recruiting
GLycaemic Outcomes With Whey Protein in ageING
Type 2 Diabetes, Appetite Regulation
Active, not recruiting
Comparative Effects of Balance and Inspiratory Muscle Training in Older Adults
Geriatric, Geriatrics Rehabilitation
Recruiting
Effect of Exergaming Program Versus Neuromuscular Exercise in Elderly People With Motor Cognitive Risk Syndrome
Motoric Cognitive Risk Syndrome, Elderly (People Aged 65 or More)
RecruitingObservational study
Nutritional Status and Patient Characteristics Upon Length of Stay, Clinical Outcome, and Survival in Older Hospitalized Patients
Geriatric, Malnutrition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
bahar anaforoğlu, prof study director
bidb@aybu.edu.tr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home exercise and Foot and ankle proprioceptive exercise in people with Geriatric and Foot Ankle Injuries, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Performance (time frame: Baseline, 8 weeks (Post-intervention), and 3 months (Follow-up).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.