<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04477408</url>
  </required_header>
  <id_info>
    <org_study_id>IstanbulMUH - 2</org_study_id>
    <nct_id>NCT04477408</nct_id>
  </id_info>
  <brief_title>Effect of Plantar Sensory Exercises on Balance and Fall Risk in Nursing Home Elderly</brief_title>
  <official_title>Effect of Plantar Sensory Exercises on Balance and Fall Risk in Nursing Home Elderly</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul Medipol University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul Medipol University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The most important cause of mortality and morbidity with the geriatric population is loss of&#xD;
      balance and the consequent falls, which is seen very often. The goal of our study is to&#xD;
      examine the effects of plantar sensation education-based exercises on balance and&#xD;
      falls.Materials and methods: 16 healthy, voluntary nursing home residents with the average&#xD;
      age 77.50±5.5. Individuals had plantar sensory exercises 40 min sessions for 3 days/week&#xD;
      during eight weeks. The study was planned as a self-controlled prospective study. Functional&#xD;
      balance was evaluated using Berg Balance Scale, dynamic balance was evaluated using 30 Second&#xD;
      Chair Stand Test, static balance and fall risk were assessed using Biodex Balance System.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study was run in Istanbul Provincial Directorate of Social Services Istanbul Prof. Dr.&#xD;
      Fahrettin Kerim-Nilüfer Gökay Nursing Home Elderly Care and Rehabilitation Center in&#xD;
      March-June 2019. This study was designed as a self-controlled prospective non-randomized&#xD;
      study.&#xD;
&#xD;
      Written informed consent was obtained from all participants. The necessary ethical approval&#xD;
      for the study was taken from the Medipol University Non-Interventional Clinical Research&#xD;
      Ethics Comittee This study was planned to be run with 20 healthy nursing home residents. The&#xD;
      criteria of being included in the study were: being above 70 years of age, scoring at least&#xD;
      22 points on the Mini Mental Test, not being bound to a wheelchair, being able to walk 20&#xD;
      meters independently, and that the sensation of the foot sole is at least on the decreased&#xD;
      protective level compare to Semmes Weinstein Monofilamnet test. The individuals with serious&#xD;
      loss of eyesight, mental retardation, a schizophrenic background, having walking disorder,&#xD;
      inconvenient in walking were not included in the study.&#xD;
&#xD;
      16 healthy aged individuals with the average age of 77.50±5.5 participated in our study. 2 of&#xD;
      the first 20 participants left the study due to health problems and 2 other participants left&#xD;
      due to personal reasons which they did not want to declare (Figure 1).&#xD;
&#xD;
      A homogeneous control group could not be created due to aging, so a control group was created&#xD;
      with the same participants. The first evaluations of our study were made within two days.&#xD;
      After the evaluation process, 4 weeks waiting period was given. At the end of this period,&#xD;
      second measurements were made for two days. Plantar sensory based exercises program lasting 8&#xD;
      weeks was applied after the second measurements were taken. Post-treatment measurements were&#xD;
      made for two days after the treatment ended. Measurements were made with MC and the&#xD;
      physiotherapist working in the nursing home.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Actual">April 1, 2020</completion_date>
  <primary_completion_date type="Actual">November 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>self controlled prospective study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Biodex Balance System - Static Balance</measure>
    <time_frame>0 week</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biodex Balance System - Static Balance</measure>
    <time_frame>4 week</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biodex Balance System - Static Balance</measure>
    <time_frame>12 week</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biodex Balance System - Fall Risk</measure>
    <time_frame>0 week</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biodex Balance System - Fall Risk</measure>
    <time_frame>4 week</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biodex Balance System - Fall Risk</measure>
    <time_frame>12 week</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Berg Balance Scale</measure>
    <time_frame>0 week</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Berg Balance Scale</measure>
    <time_frame>4 week</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Berg Balance Scale</measure>
    <time_frame>12 week</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30 Second Chair Stand Test</measure>
    <time_frame>0 week</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30 Second Chair Stand Test</measure>
    <time_frame>4 week</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30 Second Chair Stand Test</measure>
    <time_frame>12 week</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Balance; Distorted</condition>
  <condition>Plantar</condition>
  <condition>Falling</condition>
  <condition>Elderly</condition>
  <condition>Sensitivity</condition>
  <arm_group>
    <arm_group_label>plantar exercise group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>plantar sensitive exercises&#xD;
Plantar sensitive exercises:&#xD;
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)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>plantar sensory exercise group</intervention_name>
    <description>plantar sensitive exercises&#xD;
Plantar sensitive exercises:&#xD;
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)</description>
    <arm_group_label>plantar exercise group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being above 70 years of age&#xD;
&#xD;
          -  Scoring at least 22 points on the Mini Mental Test&#xD;
&#xD;
          -  Not being bound to a wheelchair&#xD;
&#xD;
          -  Being able to walk 20 meters independently&#xD;
&#xD;
          -  That the sensation of the foot sole is at least on the decreased protective level&#xD;
             compare to Semmes Weinstein Monofilamnet test.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serious loss of eyesight&#xD;
&#xD;
          -  Mental retardation&#xD;
&#xD;
          -  A schizophrenic background&#xD;
&#xD;
          -  Having walking disorder&#xD;
&#xD;
          -  Inconvenient in walking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Müyesser Cavlak</last_name>
    <role>Study Chair</role>
    <affiliation>İstanbul Medipol University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Candan Algun, Prof</last_name>
    <role>Study Director</role>
    <affiliation>İstanbul Medipol University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>İstanbul Medipol University</name>
      <address>
        <city>İstanbul</city>
        <state>Kavacık</state>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 16, 2020</last_update_submitted>
  <last_update_submitted_qc>July 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul Medipol University Hospital</investigator_affiliation>
    <investigator_full_name>muyesser cavlak</investigator_full_name>
    <investigator_title>Chief Researcher</investigator_title>
  </responsible_party>
  <keyword>plantar sensation, balance, fall, elderly</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04477408
org study id: IstanbulMUH - 2
nct id: NCT04477408
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: self controlled prospective study
primary purpose: Treatment
masking: None (Open Label)
measure: Biodex Balance System - Static Balance
time frame: 0 week
description: 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.
measure: Biodex Balance System - Static Balance
time frame: 4 week
description: 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.
measure: Biodex Balance System - Static Balance
time frame: 12 week
description: 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.
measure: Biodex Balance System - Fall Risk
time frame: 0 week
description: 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.
measure: Biodex Balance System - Fall Risk
time frame: 4 week
description: 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.
measure: Biodex Balance System - Fall Risk
time frame: 12 week
description: 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.
measure: Berg Balance Scale
time frame: 0 week
description: 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
measure: Berg Balance Scale
time frame: 4 week
description: 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
measure: Berg Balance Scale
time frame: 12 week
description: 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
measure: 30 Second Chair Stand Test
time frame: 0 week
description: 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.
measure: 30 Second Chair Stand Test
time frame: 4 week
description: 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.
measure: 30 Second Chair Stand Test
time frame: 12 week
description: 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.
arm group label: plantar exercise group
arm group type: Other
description: 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)
intervention type: Other
intervention name: plantar sensory exercise group
description: 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)
arm group label: plantar exercise group
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Müyesser Cavlak
role: Study Chair
affiliation: İstanbul Medipol University
last name: Candan Algun, Prof
role: Study Director
affiliation: İstanbul Medipol University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul Medipol University Hospital
investigator full name: muyesser cavlak
investigator title: Chief Researcher
mesh term: Hypersensitivity