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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Turkey (Türkiye)

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:

  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.

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 groups in NCT07522827
Study groupRoleWhat they receive
Intervention groupExperimentalDue 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 grupExperimentalThe 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.

  1. 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.

  1. First posted13 Apr 2026
  2. Study start24 Jan 2023
  3. Primary completion10 Jun 2024
  4. Study completion15 Jun 2024

Resources

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)
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

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.

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