Balance; DistortedNCT04477408
Effect of Plantar Sensory Exercises on Balance and Fall Risk in Nursing Home Elderly
A study testing plantar sensory exercise group in people with Balance; Distorted and Plantar, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The most important cause of mortality and morbidity with the geriatric population is loss of balance and the consequent falls, which is seen very often. The goal of our study is to examine the effects of plantar sensation education-based exercises on balance and falls.Materials and methods: 16 healthy, voluntary… 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, Plantar, Falling
- What is being tested?
- plantar sensory exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2019to 1 Apr 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
- Being above 70 years of age
- Scoring at least 22 points on the Mini Mental Test
- Not being bound to a wheelchair
- Being able to walk 20 meters independently
- That the sensation of the foot sole is at least on the decreased protective level compare to Semmes Weinstein Monofilamnet test.
Who cannot join
- Serious loss of eyesight
- Mental retardation
- A schizophrenic background
- Having walking disorder
- Inconvenient in walking
Trial locations and contacts
1 site in 1 country.
About this study
The most important cause of mortality and morbidity with the geriatric population is loss of balance and the consequent falls, which is seen very often. The goal of our study is to examine the effects of plantar sensation education-based exercises on balance and falls.Materials and methods: 16 healthy, voluntary nursing home residents with the average age 77.50±5.5. Individuals had plantar sensory exercises 40 min sessions for 3 days/week during eight weeks. The study was planned as a self-controlled prospective study. Functional balance was evaluated using Berg Balance Scale, dynamic balance was evaluated using 30 Second Chair Stand Test, static balance and fall risk were assessed using Biodex Balance System.
Read the detailed description
The study was run in Istanbul Provincial Directorate of Social Services Istanbul Prof. Dr. Fahrettin Kerim-Nilüfer Gökay Nursing Home Elderly Care and Rehabilitation Center in March-June 2019. This study was designed as a self-controlled prospective non-randomized study.
Written informed consent was obtained from all participants. The necessary ethical approval for the study was taken from the Medipol University Non-Interventional Clinical Research Ethics Comittee This study was planned to be run with 20 healthy nursing home residents. The criteria of being included in the study were: being above 70 years of age, scoring at least 22 points on the Mini Mental Test, not being bound to a wheelchair, being able to walk 20 meters independently, and that the sensation of the foot sole is at least on the decreased protective level compare to Semmes Weinstein Monofilamnet test. The individuals with serious loss of eyesight, mental retardation, a schizophrenic background, having walking disorder, inconvenient in walking were not included in the study.
16 healthy aged individuals with the average age of 77.50±5.5 participated in our study. 2 of the first 20 participants left the study due to health problems and 2 other participants left due to personal reasons which they did not want to declare (Figure 1).
A homogeneous control group could not be created due to aging, so a control group was created with the same participants. The first evaluations of our study were made within two days. After the evaluation process, 4 weeks waiting period was given. At the end of this period, second measurements were made for two days. Plantar sensory based exercises program lasting 8 weeks was applied after the second measurements were taken. Post-treatment measurements were made for two days after the treatment ended. Measurements were made with MC and the physiotherapist working in the nursing home.
- Conditions
- Balance; Distorted, Plantar, Falling, Elderly, Sensitivity
- Being tested
- plantar sensory exercise group
- Keywords
- plantar sensation, balance, fall, elderly
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plantar sensory exercise groupOther
plantar sensitive exercises
Plantar sensitive exercises:
30 minutes / 3 days per week / 8 weeks 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)
| Study group | Role | What they receive |
|---|---|---|
| plantar exercise group | Other | plantar sensitive exercises
Plantar sensitive exercises:
30 minutes / 3 days per week / 8 weeks 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) Receives: Other: plantar sensory exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodex Balance System - Static Balance
The device calculates a score of stability or loss of balance in the anteroposterior and mediolateral direction. It also calculates an average stability index by taking the average of these two scores. The general balance index score was used which was obtained according to the protocol in the guide manual of the device. The measurement of static balance was repeated 3 times on the 8th level mode with a test duration of 30 seconds, with 15 seconds of rest periods and the best result was taken into evaluation. A high score indicates that the loss of postural control and balance is high.
Measured: 0 week
Biodex Balance System - Static Balance
The device calculates a score of stability or loss of balance in the anteroposterior and mediolateral direction. It also calculates an average stability index by taking the average of these two scores. The general balance index score was used which was obtained according to the protocol in the guide manual of the device. The measurement of static balance was repeated 3 times on the 8th level mode with a test duration of 30 seconds, with 15 seconds of rest periods and the best result was taken into evaluation. A high score indicates that the loss of postural control and balance is high.
Measured: 4 week
Biodex Balance System - Static Balance
The device calculates a score of stability or loss of balance in the anteroposterior and mediolateral direction. It also calculates an average stability index by taking the average of these two scores. The general balance index score was used which was obtained according to the protocol in the guide manual of the device. The measurement of static balance was repeated 3 times on the 8th level mode with a test duration of 30 seconds, with 15 seconds of rest periods and the best result was taken into evaluation. A high score indicates that the loss of postural control and balance is high.
Measured: 12 week
Biodex Balance System - Fall Risk
For evaluate to fall risk the device was used as stated in the guide manual. The test was run gradually by moving from an unstable surface to a stable surface for 20 seconds in three sets. Between each set, the participants rested for 10 seconds. A high score indicates that the fall risk is high.
Measured: 0 week
Biodex Balance System - Fall Risk
For evaluate to fall risk the device was used as stated in the guide manual. The test was run gradually by moving from an unstable surface to a stable surface for 20 seconds in three sets. Between each set, the participants rested for 10 seconds. A high score indicates that the fall risk is high.
Measured: 4 week
Biodex Balance System - Fall Risk
For evaluate to fall risk the device was used as stated in the guide manual. The test was run gradually by moving from an unstable surface to a stable surface for 20 seconds in three sets. Between each set, the participants rested for 10 seconds. A high score indicates that the fall risk is high.
Measured: 12 week
Secondary outcomes (6)
Berg Balance Scale
This test evaluates the individuals' ability to maintain their balance during functional activity. Berg Balance Scale is run with 14 different activities. A score between 0-20 shows high risk, a score between 21-40 shows medium risk and a score between 41-64 shows low risk
Measured: 0 week
Berg Balance Scale
This test evaluates the individuals' ability to maintain their balance during functional activity. Berg Balance Scale is run with 14 different activities. A score between 0-20 shows high risk, a score between 21-40 shows medium risk and a score between 41-64 shows low risk
Measured: 4 week
Berg Balance Scale
This test evaluates the individuals' ability to maintain their balance during functional activity. Berg Balance Scale is run with 14 different activities. A score between 0-20 shows high risk, a score between 21-40 shows medium risk and a score between 41-64 shows low risk
Measured: 12 week
30 Second Chair Stand Test
30 Second Chair Stand Test evaluates an individuals' dynamic balance with their activity of sitting and standing up. It is performed by asking the participant to constantly sit down and stand up from a chair within 30 seconds and noting how many times they do it.
Measured: 0 week
30 Second Chair Stand Test
30 Second Chair Stand Test evaluates an individuals' dynamic balance with their activity of sitting and standing up. It is performed by asking the participant to constantly sit down and stand up from a chair within 30 seconds and noting how many times they do it.
Measured: 4 week
30 Second Chair Stand Test
30 Second Chair Stand Test evaluates an individuals' dynamic balance with their activity of sitting and standing up. It is performed by asking the participant to constantly sit down and stand up from a chair within 30 seconds and noting how many times they do it.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start1 May 2019
- Primary completion1 Nov 2019
- Study completion1 Apr 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
- Not applicable
- Intervention model
- Single group
- Model description
- self controlled prospective study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, muyesser cavlak, Istanbul Medipol University Hospital
- Investigators
- Müyesser Cavlak, Study chair, İstanbul Medipol UniversityCandan Algun, Prof, Study director, İstanbul Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477408
- Sponsor's protocol ID
- IstanbulMUH - 2
- Status last verified
- Jul 2020
- First submitted
- 14 Jul 2020
- Last updated
- 12 Mar 2024
- 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Plantar Sensory Exercises on Balance and Fall Risk in Nursing Home Elderly
- ClinicalTrials.gov ID
- NCT04477408
- Acronym / sponsor ID
- IstanbulMUH - 2
- Conditions
- Balance; Distorted, Plantar, Falling, Elderly, Sensitivity
- Keywords
- plantar sensation, balance, fall, elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 20 Jul 2020 (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.
The most important cause of mortality and morbidity with the geriatric population is loss of balance and the consequent falls, which is seen very often. The goal of our study is to examine the effects of plantar sensation education-based exercises on balance and falls.Materials and methods: 16 healthy, voluntary nursing home residents with the average age 77.50±5.5. Individuals had plantar sensory exercises 40 min sessions for 3 days/week during eight weeks. The study was planned as a self-controlled prospective study. Functional balance was evaluated using Berg Balance Scale, dynamic balance was evaluated using 30 Second Chair Stand Test, static balance and fall risk were assessed using Biodex Balance System.
Detailed description
The study was run in Istanbul Provincial Directorate of Social Services Istanbul Prof. Dr. Fahrettin Kerim-Nilüfer Gökay Nursing Home Elderly Care and Rehabilitation Center in March-June 2019. This study was designed as a self-controlled prospective non-randomized study.
Written informed consent was obtained from all participants. The necessary ethical approval for the study was taken from the Medipol University Non-Interventional Clinical Research Ethics Comittee This study was planned to be run with 20 healthy nursing home residents. The criteria of being included in the study were: being above 70 years of age, scoring at least 22 points on the Mini Mental Test, not being bound to a wheelchair, being able to walk 20 meters independently, and that the sensation of the foot sole is at least on the decreased protective level compare to Semmes Weinstein Monofilamnet test. The individuals with serious loss of eyesight, mental retardation, a schizophrenic background, having walking disorder, inconvenient in walking were not included in the study.
16 healthy aged individuals with the average age of 77.50±5.5 participated in our study. 2 of the first 20 participants left the study due to health problems and 2 other participants left due to personal reasons which they did not want to declare (Figure 1).
A homogeneous control group could not be created due to aging, so a control group was created with the same participants. The first evaluations of our study were made within two days. After the evaluation process, 4 weeks waiting period was given. At the end of this period, second measurements were made for two days. Plantar sensory based exercises program lasting 8 weeks was applied after the second measurements were taken. Post-treatment measurements were made for two days after the treatment ended. Measurements were made with MC and the physiotherapist working in the nursing home.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- self controlled prospective study
| Arm | Type | Receives |
|---|---|---|
| plantar exercise group | Other | Other: plantar sensory exercise groupplantar sensitive exercises Plantar sensitive exercises: 30 minutes / 3 days per week / 8 weeks 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) |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Being above 70 years of age
- Scoring at least 22 points on the Mini Mental Test
- Not being bound to a wheelchair
- Being able to walk 20 meters independently
- That the sensation of the foot sole is at least on the decreased protective level compare to Semmes Weinstein Monofilamnet test.
Key exclusion criteria (5 listed)
- Serious loss of eyesight
- Mental retardation
- A schizophrenic background
- Having walking disorder
- Inconvenient in 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 sensory exercise groupplantar sensitive exercises Plantar sensitive exercises: 30 minutes / 3 days per week / 8 weeks 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) | Other | plantar exercise group |
Primary outcome
Biodex Balance System - Static Balance
Time frame: 0 week
The device calculates a score of stability or loss of balance in the anteroposterior and mediolateral direction. It also calculates an average stability index by taking the average of these two scores. The general balance index score was used which was obtained according to the protocol in the guide manual of the device. The measurement of static balance was repeated 3 times on the 8th level mode with a test duration of 30 seconds, with 15 seconds of rest periods and the best result was taken into evaluation. A high score indicates that the loss of postural control and balance is high.
Biodex Balance System - Static Balance
Time frame: 4 week
The device calculates a score of stability or loss of balance in the anteroposterior and mediolateral direction. It also calculates an average stability index by taking the average of these two scores. The general balance index score was used which was obtained according to the protocol in the guide manual of the device. The measurement of static balance was repeated 3 times on the 8th level mode with a test duration of 30 seconds, with 15 seconds of rest periods and the best result was taken into evaluation. A high score indicates that the loss of postural control and balance is high.
Biodex Balance System - Static Balance
Time frame: 12 week
The device calculates a score of stability or loss of balance in the anteroposterior and mediolateral direction. It also calculates an average stability index by taking the average of these two scores. The general balance index score was used which was obtained according to the protocol in the guide manual of the device. The measurement of static balance was repeated 3 times on the 8th level mode with a test duration of 30 seconds, with 15 seconds of rest periods and the best result was taken into evaluation. A high score indicates that the loss of postural control and balance is high.
Biodex Balance System - Fall Risk
Time frame: 0 week
For evaluate to fall risk the device was used as stated in the guide manual. The test was run gradually by moving from an unstable surface to a stable surface for 20 seconds in three sets. Between each set, the participants rested for 10 seconds. A high score indicates that the fall risk is high.
Biodex Balance System - Fall Risk
Time frame: 4 week
For evaluate to fall risk the device was used as stated in the guide manual. The test was run gradually by moving from an unstable surface to a stable surface for 20 seconds in three sets. Between each set, the participants rested for 10 seconds. A high score indicates that the fall risk is high.
Biodex Balance System - Fall Risk
Time frame: 12 week
For evaluate to fall risk the device was used as stated in the guide manual. The test was run gradually by moving from an unstable surface to a stable surface for 20 seconds in three sets. Between each set, the participants rested for 10 seconds. A high score indicates that the fall risk is high.
6 secondary outcomes
Berg Balance Scale
Time frame: 0 week
Berg Balance Scale
Time frame: 4 week
Berg Balance Scale
Time frame: 12 week
30 Second Chair Stand Test
Time frame: 0 week
30 Second Chair Stand Test
Time frame: 4 week
30 Second Chair Stand Test
Time frame: 12 week
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 12 Mar 2024.
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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.
Müyesser Cavlak study chair
İstanbul Medipol University
Candan Algun, Prof study director
İstanbul 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 sensory exercise group in people with Balance; Distorted and Plantar, run by Istanbul Medipol University Hospital 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 5 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 12 Mar 2024. 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?
Biodex Balance System - Static Balance (time frame: 0 week). The study lists 6 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 12 Mar 2024.