Balance; DistortedNCT04140656
The Effects of Plantar Sensory Based Physiotherapy Interventions on Balance and Fallings of Nursing Home Elderly
A study testing Plantar sensitive exercises and Textured insole in people with Balance; Distorted and Falling, run by muyesser cavlak at 1 site in Turkey (Türkiye).
Trial summary
Aging in all living things is defined as a normal physiological process that causes a decrease in realistic body function. According to the World Health Organization; It is classified as 65 years old and older and 85 years old and older (1). Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Balance; Distorted, Falling
- What is being tested?
- Plantar sensitive exercises and Textured insole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2019to 1 Oct 2020
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Voluntariness
- 70 years and older
- Cognitive functions are sufficient for communication (MM score 22 and above)
- 20 meters independent walk
- The soles of the soles are at least at the reduced protective sensory level
Who cannot join
- Severe visual loss
- A history of mental retardation or schizophrenia
- Person has any problems to prevent walking
Trial locations and contacts
1 site in 1 country.
About this study
Aging in all living things is defined as a normal physiological process that causes a decrease in realistic body function. According to the World Health Organization; It is classified as 65 years old and older and 85 years old and older (1). Characteristics of aging; decrease in reserve capacity of organ systems, decrease in homeostatic control, decrease in adaptability to environmental factors, decrease in stress response capacity (3). Stability is defined as postural stimulation against changes in the center of gravity during rest and activity. Postural answers that provide this harmony; vestibular, proprioceptive and visual data in the central nervous system. In older people, static balance can be maintained for a longer period of time, while dynamic balance may deteriorate more quickly. Aging-affected muscle strength, joint mobility, proprioceptive, vestibular and visual loss also make postural control difficult to achieve. Although the physiological mechanism underlying the risk of loss of equilibrium and falls is multifaceted, it is mostly caused by somatosensory sensitivity and decreased neuromuscular capacity (3-5). It has been determined that one third of the elderly individuals living in the society have fallen at least once a year and these rates have been stated to increase to 60% in nursing homes. Falls cause long-term disability, stay in nursing homes, in the absence of a serious injury as a result of falling, there is a fear of falling, which causes a limitation in activities of daily living. Due to the physiology of aging, it is stated that peripheral sensation decreases in older ages (12). Mold showed that bilateral somatosensorial disorder was present in approximately 26% of individuals aged 65-74, 36% of those aged 75-84, and 54% of those aged 85 years (13). In the literature, it was reported that plantar sensory loss in the elderly affects balance, mobility and gait and is a risk factor for falls (14). Different senses can be sensed by sensing receptors during the exercise program to increase sensory perception. Aerobic and strengthening exercise, feedback, virtual reality have been used in the studies on balance and falling seen in the elderly in recent years. However, a program aimed at increasing plantar sensation and it has not been found in the literature. In this study, physiotherapy programs aimed at increasing plantar sensation in the elderly will be compared.
Read the detailed description
The study is planned to be conducted between the years of 2019-January-2020 for elderly people over 70 years old who live in Küçük Çamlıca Fahrettin Kerim Gökay Nursing Home. The study was planned as a randomized controlled clinical trial; By simple randomization method, cases will be divided into two groups. There are 47 elderly people over 70 years old in the nursing home to be studied. The sample size was planned to be 16 for each group.Group 1 (n:16), group 2 (n:17). 40 minutes / 3 days per week / 8 weeks long program will be applied to both groups. Four weeks after the first measurement, the second measurement was performed. Thus, pilot study was made. After the second measurement, rehabilitation program was started in both groups.After the 8-week program is finished, the third measurements will be made. After the third measurements, the fourth measurement will be done 4 weeks later for late results.The measurements are as follows.
Primary results: electronic pedobarography device for static and dynamic base pressure changes. Biodex balance test for measuring fall risk and static stability. For secondary results; 30 second Chair stand test, Berg balance scale, Semmes weinstein monofilament test.
- Conditions
- Balance; Distorted, Falling
- Being tested
- Plantar sensitive exercises, Textured insole
- Keywords
- elderly, balance, falling, plantar sensitivity, insole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plantar sensitive exercisesOther
Plantar sensitive exercises:
40 minutes / 3 days per week / 8 weeks Warm up exercise (5 minute) Walking on different 4 different textured floors and hot floor (15 minute) Trying to recognize small objects with the soles of the feet (5min) Seated work with barbed ball and balance pad (5min) Massage to the sole of the foot with different textured fabrics (5min) Cooling exercise (5 min)
Textured insoleOther
Textured insole group.
Plantar sensitive exercises with insole 40 minutes / 3 days per week / 8 weeks (all exercises will be done with insoles) Warm up exercise (5 minute) Walking on flat ground (15 minute) Exercise with roller under the sole of the foot (5 minute) Seated work with barbed balance pad (5 min) Dorsi flexion and plantar flexion and hip flexion exercises (5min). Cooling exercise (5 min)
| Study group | Role | What they receive |
|---|---|---|
| Plantar sensitive exercise group | Active comparator | Plantar sensitive exercises: Receives: Other: Plantar sensitive exercises |
| Textured insole group | Active comparator | Textured insole group Receives: Other: Textured insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pedobarographic investigation
By means of pressure sensors in force platforms, foot pressure is detected and transferred to computer environment. Static and dynamic measurement is also possible. Plantar pressure can be measured as total and divided areas and it will be combined to report g/cm2. Plantar contact area can be measured as total and divided areas and it will be combined to report cm2.
Measured: day 0 (before intervention)
Pedobarographic investigation
By means of pressure sensors in force platforms, foot pressure is detected and transferred to computer environment. Static and dynamic measurement is also possible. Plantar pressure can be measured as total and divided areas and it will be combined to report g/cm2. Plantar contact area can be measured as total and divided areas and it will be combined to report cm2.
Measured: 4 weeks
Pedobarographic investigation
By means of pressure sensors in force platforms, foot pressure is detected and transferred to computer environment. Static and dynamic measurement is also possible. Plantar pressure can be measured as total and divided areas and it will be combined to report g/cm2. Plantar contact area can be measured as total and divided areas and it will be combined to report cm2.
Measured: 12 weeks
Pedobarographic investigation
By means of pressure sensors in force platforms, foot pressure is detected and transferred to computer environment. Static and dynamic measurement is also possible. Plantar pressure can be measured as total and divided areas and it will be combined to report g/cm2. Plantar contact area can be measured as total and divided areas and it will be combined to report cm2.
Measured: 16 weeks
Biodex Balance System
It is a multi-axis device which objectively measures the balance of the person in static state or under dynamic stress and records the measurement results. The Biodex Balance System permits a 20 ° inclination of the foot platform in all directions. Thus, it provides maximum stimulation of the mechanical sensors in the ankle. Biodex Balance System measurements are calculated in degrees for each direction It can be done by creating a dynamic environment for the measurement of fall risk on the same platform .
Measured: day 0 (before intervention)
Biodex Balance System
It is a multi-axis device which objectively measures the balance of the person in static state or under dynamic stress and records the measurement results. The Biodex Balance System permits a 20 ° inclination of the foot platform in all directions. Thus, it provides maximum stimulation of the mechanical sensors in the ankle. Biodex Balance System measurements are calculated in degrees for each direction It can be done by creating a dynamic environment for the measurement of fall risk on the same platform .
Measured: 4 weeks
Biodex Balance System
It is a multi-axis device which objectively measures the balance of the person in static state or under dynamic stress and records the measurement results. The Biodex Balance System permits a 20 ° inclination of the foot platform in all directions. Thus, it provides maximum stimulation of the mechanical sensors in the ankle. Biodex Balance System measurements are calculated in degrees for each direction It can be done by creating a dynamic environment for the measurement of fall risk on the same platform .
Measured: 12 weeks
Biodex Balance System
It is a multi-axis device which objectively measures the balance of the person in static state or under dynamic stress and records the measurement results. The Biodex Balance System permits a 20 ° inclination of the foot platform in all directions. Thus, it provides maximum stimulation of the mechanical sensors in the ankle. Biodex Balance System measurements are calculated in degrees for each direction It can be done by creating a dynamic environment for the measurement of fall risk on the same platform .
Measured: 16 weeks
Secondary outcomes (12)
Berg Balance Scala
It is a 14-item clinical scale evaluating static and dynamic equilibrium abilities, each section rated from 0 (poor) to 4 (best). The highest score is 56. A score of less than 45 is an indicator of addiction in daily life. Evaluates the level of dependence and / or independence during positions such as standing up from sitting, standing with feet adjacent, standing in tandem position, staying in balance on one leg and ability to change position. The highest scores indicate the best balance score.
Measured: day 0 (before intervention)
Berg Balance Scala
It is a 14-item clinical scale evaluating static and dynamic equilibrium abilities, each section rated from 0 (poor) to 4 (best). The highest score is 56. A score of less than 45 is an indicator of addiction in daily life. Evaluates the level of dependence and / or independence during positions such as standing up from sitting, standing with feet adjacent, standing in tandem position, staying in balance on one leg and ability to change position. The highest scores indicate the best balance score
Measured: 4 weeks
Berg Balance Scala
It is a 14-item clinical scale evaluating static and dynamic equilibrium abilities, each section rated from 0 (poor) to 4 (best). The highest score is 56. A score of less than 45 is an indicator of addiction in daily life. Evaluates the level of dependence and / or independence during positions such as standing up from sitting, standing with feet adjacent, standing in tandem position, staying in balance on one leg and ability to change position. The highest scores indicate the best balance score
Measured: 12 weeks
Berg Balance
It is a 14-item clinical scale evaluating static and dynamic equilibrium abilities, each section rated from 0 (poor) to 4 (best). The highest score is 56. A score of less than 45 is an indicator of addiction in daily life. Evaluates the level of dependence and / or independence during positions such as standing up from sitting, standing with feet adjacent, standing in tandem position, staying in balance on one leg and ability to change position. The highest scores indicate the best balance score
Measured: 16 weeks
30 Second Chair Stand Test
A test that assesses the person's sit-up activity, lower extremity strength and dynamic balance. Number of sitting and getting up in 30 seconds is noted.
Measured: day 0 (before intervention)
30 Second Chair Stand Test
A test that assesses the person's sit-up activity, lower extremity strength and dynamic balance. Number of sitting and getting up in 30 seconds is noted.
Measured: 4 weeks
30 Second Chair Stand Test
A test that assesses the person's sit-up activity, lower extremity strength and dynamic balance. Number of sitting and getting up in 30 seconds is noted.
Measured: 12 weeks
30 Second Chair Stand Test
A test that assesses the person's sit-up activity, lower extremity strength and dynamic balance. Number of sitting and getting up in 30 seconds is noted.
Measured: 16 weeks
Semmes Weinstein Monofilament Test
Consists of 6 different diameter and equal length monofilments. The test of the sense of touch by questioning whether the person feels the monofilament touches while their eyes are closed.
Measured: day 0 (before intervention)
Semmes Weinstein Monofilament Test
Consists of 6 different diameter and equal length monofilments. The test of the sense of touch by questioning whether the person feels the monofilament touches while their eyes are closed.
Measured: 4 weeks
Semmes Weinstein Monofilament Test
Consists of 6 different diameter and equal length monofilments. The test of the sense of touch by questioning whether the person feels the monofilament touches while their eyes are closed.
Measured: 12 weeks
Semmes Weinstein Monofilament Test
Consists of 6 different diameter and equal length monofilments. The test of the sense of touch by questioning whether the person feels the monofilament touches while their eyes are closed.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start1 Jun 2019
- Primary completion1 Sep 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Balance; DistortedStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was planned as a randomized controlled clinical trial; by simple randomization method, cases will be divided into two groups. There are 40 elderly people in the nursing home to be studied. Study was planned as group 1 and group 2. 40 minutes / 3 days per week / 8 weeks long program will be applied to both groups. Four weeks after the first measurement, the second measurement was performed. After the second measurement, rehabilitation program was started in both groups. After the 8-week program is finished, the third measurements will be made. After the third measurements, the fourth measurement will be done 4 weeks later for late results. The measurements are as follows: Primary results: electronic pedobarography device for static and dynamic base pressure changes. Biodex balance test for measuring fall risk and static stability. For secondary results; 30 second Chair stand test, Berg balance scale, Semmes weinstein monofilament test.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- muyesser cavlak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, muyesser cavlak, Istanbul Medipol University Hospital
- Investigators
- Candan ALGUN, Prof, Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140656
- Sponsor's protocol ID
- 10840098-604.01.01-E52392
- Status last verified
- Aug 2025
- First submitted
- 4 Oct 2019
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Plantar Sensory Based Physiotherapy Interventions on Balance and Fallings of Nursing Home Elderly
- ClinicalTrials.gov ID
- NCT04140656
- Acronym / sponsor ID
- 10840098-604.01.01-E52392
- Conditions
- Balance; Distorted, Falling
- Keywords
- elderly, balance, falling, plantar sensitivity, insole
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- muyesser cavlakUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 28 Oct 2019 (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.
Aging in all living things is defined as a normal physiological process that causes a decrease in realistic body function. According to the World Health Organization; It is classified as 65 years old and older and 85 years old and older (1). Characteristics of aging; decrease in reserve capacity of organ systems, decrease in homeostatic control, decrease in adaptability to environmental factors, decrease in stress response capacity (3). Stability is defined as postural stimulation against changes in the center of gravity during rest and activity. Postural answers that provide this harmony; vestibular, proprioceptive and visual data in the central nervous system. In older people, static balance can be maintained for a longer period of time, while dynamic balance may deteriorate more quickly. Aging-affected muscle strength, joint mobility, proprioceptive, vestibular and visual loss also make postural control difficult to achieve. Although the physiological mechanism underlying the risk of loss of equilibrium and falls is multifaceted, it is mostly caused by somatosensory sensitivity and decreased neuromuscular capacity (3-5). It has been determined that one third of the elderly individuals living in the society have fallen at least once a year and these rates have been stated to increase to 60% in nursing homes. Falls cause long-term disability, stay in nursing homes, in the absence of a serious injury as a result of falling, there is a fear of falling, which causes a limitation in activities of daily living. Due to the physiology of aging, it is stated that peripheral sensation decreases in older ages (12). Mold showed that bilateral somatosensorial disorder was present in approximately 26% of individuals aged 65-74, 36% of those aged 75-84, and 54% of those aged 85 years (13). In the literature, it was reported that plantar sensory loss in the elderly affects balance, mobility and gait and is a risk factor for falls (14). Different senses can be sensed by sensing receptors during the exercise program to increase sensory perception. Aerobic and strengthening exercise, feedback, virtual reality have been used in the studies on balance and falling seen in the elderly in recent years. However, a program aimed at increasing plantar sensation and it has not been found in the literature. In this study, physiotherapy programs aimed at increasing plantar sensation in the elderly will be compared.
Detailed description
The study is planned to be conducted between the years of 2019-January-2020 for elderly people over 70 years old who live in Küçük Çamlıca Fahrettin Kerim Gökay Nursing Home. The study was planned as a randomized controlled clinical trial; By simple randomization method, cases will be divided into two groups. There are 47 elderly people over 70 years old in the nursing home to be studied. The sample size was planned to be 16 for each group.Group 1 (n:16), group 2 (n:17). 40 minutes / 3 days per week / 8 weeks long program will be applied to both groups. Four weeks after the first measurement, the second measurement was performed. Thus, pilot study was made. After the second measurement, rehabilitation program was started in both groups.After the 8-week program is finished, the third measurements will be made. After the third measurements, the fourth measurement will be done 4 weeks later for late results.The measurements are as follows.
Primary results: electronic pedobarography device for static and dynamic base pressure changes. Biodex balance test for measuring fall risk and static stability. For secondary results; 30 second Chair stand test, Berg balance scale, Semmes weinstein monofilament test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The study was planned as a randomized controlled clinical trial; by simple randomization method, cases will be divided into two groups. There are 40 elderly people in the nursing home to be studied. Study was planned as group 1 and group 2. 40 minutes / 3 days per week / 8 weeks long program will be applied to both groups. Four weeks after the first measurement, the second measurement was performed. After the second measurement, rehabilitation program was started in both groups. After the 8-week program is finished, the third measurements will be made. After the third measurements, the fourth measurement will be done 4 weeks later for late results. The measurements are as follows: Primary results: electronic pedobarography device for static and dynamic base pressure changes. Biodex balance test for measuring fall risk and static stability. For secondary results; 30 second Chair stand test, Berg balance scale, Semmes weinstein monofilament test.
| Arm | Type | Receives |
|---|---|---|
| Plantar sensitive exercise group | Active comparator | Other: Plantar sensitive exercisesPlantar sensitive exercises: |
| Textured insole group | Active comparator | Other: Textured insoleTextured insole group |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Voluntariness
- 70 years and older
- Cognitive functions are sufficient for communication (MM score 22 and above)
- 20 meters independent walk
- The soles of the soles are at least at the reduced protective sensory level
Key exclusion criteria (3 listed)
- Severe visual loss
- A history of mental retardation or schizophrenia
- Person has any problems to prevent walking
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 |
|---|---|---|
| Plantar sensitive exercisesPlantar sensitive exercises: 40 minutes / 3 days per week / 8 weeks Warm up exercise (5 minute) Walking on different 4 different textured floors and hot floor (15 minute) Trying to recognize small objects with the soles of the feet (5min) Seated work with barbed ball and balance pad (5min) Massage to the sole of the foot with different textured fabrics (5min) Cooling exercise (5 min) | Other | Plantar sensitive exercise group |
| Textured insoleTextured insole group. Plantar sensitive exercises with insole 40 minutes / 3 days per week / 8 weeks (all exercises will be done with insoles) Warm up exercise (5 minute) Walking on flat ground (15 minute) Exercise with roller under the sole of the foot (5 minute) Seated work with barbed balance pad (5 min) Dorsi flexion and plantar flexion and hip flexion exercises (5min). Cooling exercise (5 min) | Other | Textured insole group |
Primary outcome
Pedobarographic investigation
Time frame: day 0 (before intervention)
By means of pressure sensors in force platforms, foot pressure is detected and transferred to computer environment. Static and dynamic measurement is also possible. Plantar pressure can be measured as total and divided areas and it will be combined to report g/cm2. Plantar contact area can be measured as total and divided areas and it will be combined to report cm2.
Pedobarographic investigation
Time frame: 4 weeks
By means of pressure sensors in force platforms, foot pressure is detected and transferred to computer environment. Static and dynamic measurement is also possible. Plantar pressure can be measured as total and divided areas and it will be combined to report g/cm2. Plantar contact area can be measured as total and divided areas and it will be combined to report cm2.
Pedobarographic investigation
Time frame: 12 weeks
By means of pressure sensors in force platforms, foot pressure is detected and transferred to computer environment. Static and dynamic measurement is also possible. Plantar pressure can be measured as total and divided areas and it will be combined to report g/cm2. Plantar contact area can be measured as total and divided areas and it will be combined to report cm2.
Pedobarographic investigation
Time frame: 16 weeks
By means of pressure sensors in force platforms, foot pressure is detected and transferred to computer environment. Static and dynamic measurement is also possible. Plantar pressure can be measured as total and divided areas and it will be combined to report g/cm2. Plantar contact area can be measured as total and divided areas and it will be combined to report cm2.
Biodex Balance System
Time frame: day 0 (before intervention)
It is a multi-axis device which objectively measures the balance of the person in static state or under dynamic stress and records the measurement results. The Biodex Balance System permits a 20 ° inclination of the foot platform in all directions. Thus, it provides maximum stimulation of the mechanical sensors in the ankle. Biodex Balance System measurements are calculated in degrees for each direction It can be done by creating a dynamic environment for the measurement of fall risk on the same platform .
Biodex Balance System
Time frame: 4 weeks
It is a multi-axis device which objectively measures the balance of the person in static state or under dynamic stress and records the measurement results. The Biodex Balance System permits a 20 ° inclination of the foot platform in all directions. Thus, it provides maximum stimulation of the mechanical sensors in the ankle. Biodex Balance System measurements are calculated in degrees for each direction It can be done by creating a dynamic environment for the measurement of fall risk on the same platform .
Biodex Balance System
Time frame: 12 weeks
It is a multi-axis device which objectively measures the balance of the person in static state or under dynamic stress and records the measurement results. The Biodex Balance System permits a 20 ° inclination of the foot platform in all directions. Thus, it provides maximum stimulation of the mechanical sensors in the ankle. Biodex Balance System measurements are calculated in degrees for each direction It can be done by creating a dynamic environment for the measurement of fall risk on the same platform .
Biodex Balance System
Time frame: 16 weeks
It is a multi-axis device which objectively measures the balance of the person in static state or under dynamic stress and records the measurement results. The Biodex Balance System permits a 20 ° inclination of the foot platform in all directions. Thus, it provides maximum stimulation of the mechanical sensors in the ankle. Biodex Balance System measurements are calculated in degrees for each direction It can be done by creating a dynamic environment for the measurement of fall risk on the same platform .
12 secondary outcomes
Berg Balance Scala
Time frame: day 0 (before intervention)
Berg Balance Scala
Time frame: 4 weeks
Berg Balance Scala
Time frame: 12 weeks
Berg Balance
Time frame: 16 weeks
30 Second Chair Stand Test
Time frame: day 0 (before intervention)
30 Second Chair Stand Test
Time frame: 4 weeks
30 Second Chair Stand Test
Time frame: 12 weeks
30 Second Chair Stand Test
Time frame: 16 weeks
Semmes Weinstein Monofilament Test
Time frame: day 0 (before intervention)
Semmes Weinstein Monofilament Test
Time frame: 4 weeks
Semmes Weinstein Monofilament Test
Time frame: 12 weeks
Semmes Weinstein Monofilament Test
Time frame: 16 weeks
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 11 Aug 2025.
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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.
Candan ALGUN, Prof study director
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plantar sensitive exercises and Textured insole in people with Balance; Distorted and Falling, run by muyesser cavlak 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 5 inclusion and 3 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 11 Aug 2025. 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?
Pedobarographic investigation (time frame: day 0 (before intervention)). The study lists 8 primary outcomes in all. 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 11 Aug 2025.