<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/NCT01730859</url>
  </required_header>
  <id_info>
    <org_study_id>90-2339</org_study_id>
    <nct_id>NCT01730859</nct_id>
  </id_info>
  <brief_title>The Effect of Ankle Taping and Balance Exercises on Postural Stability</brief_title>
  <official_title>The Effect of Ankle Taping and Balance Exercises on Postural Stability Indices in Healthy Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zahedan University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zahedan University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Both taping and balance exercises have effects on dynamic balance, so this study compared&#xD;
      ankle taping and balance exercise on postural stability indices in healthy women. we&#xD;
      hypothesized that both balance exercise and taping would increase stability indices but the&#xD;
      effects of balance exercise was more greater than taping.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ability to control the body in the space is a complex interaction between musculoskeletal&#xD;
      and neural systems. This set is called postural control system. Postural control involves the&#xD;
      control of body position in space for the dual purposes of postural stability and postural&#xD;
      orientation. Balance process is divided into four-stage by Sullivan and Markos: mobility,&#xD;
      stability, controlled mobility, and skill. Several types of exercise have been proposed to&#xD;
      improve proprioception. Bout and Gahery stated that balance exercises improve neuromuscular&#xD;
      relations and reduces the proprioception errors. They believe that those who have more&#xD;
      proprioception difficulty may benefit more from exercise therapy.Taping is another technique&#xD;
      to enhance proprioception. Improvement in proprioception leads to better function and&#xD;
      reduction of disability. Kinesiotaping is being used to prevent injuries and to help curing&#xD;
      the injury. It can also improve efficiency in sport, improve lymph and venous circulation,&#xD;
      decrease edema, stimulate the mechanoreceptors and increase awareness of subject about the&#xD;
      ankle position, reduces the pain and improves muscle performance&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">October 2011</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stability Index</measure>
    <time_frame>6 weeks</time_frame>
    <description>Biodex Balance System: It is possible to quantify the neuromuscular control performance by evaluating subject's ability in single and double leg balance on a stable or unstable surface. This system can be used to do exercises in order to increase kinesthetic abilities and improve proprioception.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>zone and quadrant</measure>
    <time_frame>6 weeks</time_frame>
    <description>In balance testing which quadrant and zone are used by subjects.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>BMI</measure>
    <time_frame>6 weeks</time_frame>
    <description>The height of the subjects measured by a meter with 1 cm accuracy and a digital weighting scale used for measuring subjects</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Disturbance; Balance, Labyrinth</condition>
  <condition>Proprioceptive Disorders</condition>
  <arm_group>
    <arm_group_label>Balance exrercise and ankle taping</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Balance Exercises:Balance exercises for 6 weeks, 3 sessions per week and each session was 40 minutes for training group.&#xD;
Ankle taping: Ankle joint taping was performed for 6 weeks and was renewed three times a week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Balance exercise and ankle taping</intervention_name>
    <description>Balance Exercises: The first group performed balance exercise which last for six weeks, 3 times a week, and 40 minutes each session. Each session started by several minutes of slow walking and progressive stretching of ankle, knee and hip muscles which was gradually increased in time and repetition. After that, balance exercises were performed.&#xD;
Ankle taping: In second group Ankle joint taping continued for 6 weeks and was renewed three times a week.</description>
    <arm_group_label>Balance exrercise and ankle taping</arm_group_label>
    <other_name>Balance Exercises</other_name>
    <other_name>Ankle taping</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  having no pain in ankle joint, not having sport activity in the period of this study,&#xD;
             healthy sensory motor function in lower limb, no history of neuromuscular disease,&#xD;
             vertigo or any uncorrected visual problems, any kind of ankle injury or lower limb&#xD;
             surgery, taking sedative medication, cardiovascular, neurologic, and pulmonary&#xD;
             disease, balance problems, rheumatoid disease, psychological disease, body mass index&#xD;
             between 17 to25.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ankle pain, allergy to tape, and not completing all interventional sessions.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>22 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>School of rehabilitaion Sciences</name>
      <address>
        <city>Zahedan</city>
        <state>Sistan and Baluchestan</state>
        <zip>98167-43175</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <link>
    <url>http://www.biodex.com</url>
    <description>The Biodex Balance System SD has been designed to meet the needs of everyone looking to improve balance, increase agility, develop muscle tone and treat a wide variety of pathologies.</description>
  </link>
  <results_reference>
    <citation>Lentell G, Baas B, Lopez D, McGuire L, Sarrels M, Snyder P. The contributions of proprioceptive deficits, muscle function, and anatomic laxity to functional instability of the ankle. J Orthop Sports Phys Ther. 1995 Apr;21(4):206-15. doi: 10.2519/jospt.1995.21.4.206.</citation>
    <PMID>7773272</PMID>
  </results_reference>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 10, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>November 21, 2012</last_update_submitted>
  <last_update_submitted_qc>November 21, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 22, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zahedan University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Dr. Asghar Akbari</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>Balance exercise</keyword>
  <keyword>Ankle</keyword>
  <keyword>Postural stability</keyword>
  <keyword>Taping</keyword>
  <keyword>Biodex</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Somatosensory Disorders</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/NCT01730859
org study id: 90-2339
nct id: NCT01730859
lead sponsor: 
has dmc: No
Both taping and balance exercises have effects on dynamic balance, so this study compared
      ankle taping and balance exercise on postural stability indices in healthy women. we
      hypothesized that both balance exercise and taping would increase stability indices but the
      effects of balance exercise was more greater than taping.
The ability to control the body in the space is a complex interaction between musculoskeletal
      and neural systems. This set is called postural control system. Postural control involves the
      control of body position in space for the dual purposes of postural stability and postural
      orientation. Balance process is divided into four-stage by Sullivan and Markos: mobility,
      stability, controlled mobility, and skill. Several types of exercise have been proposed to
      improve proprioception. Bout and Gahery stated that balance exercises improve neuromuscular
      relations and reduces the proprioception errors. They believe that those who have more
      proprioception difficulty may benefit more from exercise therapy.Taping is another technique
      to enhance proprioception. Improvement in proprioception leads to better function and
      reduction of disability. Kinesiotaping is being used to prevent injuries and to help curing
      the injury. It can also improve efficiency in sport, improve lymph and venous circulation,
      decrease edema, stimulate the mechanoreceptors and increase awareness of subject about the
      ankle position, reduces the pain and improves muscle performance
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Stability Index
time frame: 6 weeks
description: Biodex Balance System: It is possible to quantify the neuromuscular control performance by evaluating subject's ability in single and double leg balance on a stable or unstable surface. This system can be used to do exercises in order to increase kinesthetic abilities and improve proprioception.
measure: zone and quadrant
time frame: 6 weeks
description: In balance testing which quadrant and zone are used by subjects.
measure: BMI
time frame: 6 weeks
description: The height of the subjects measured by a meter with 1 cm accuracy and a digital weighting scale used for measuring subjects
arm group label: Balance exrercise and ankle taping
arm group type: Experimental
description: Balance Exercises:Balance exercises for 6 weeks, 3 sessions per week and each session was 40 minutes for training group.
Ankle taping: Ankle joint taping was performed for 6 weeks and was renewed three times a week.
intervention type: Other
intervention name: Balance exercise and ankle taping
description: Balance Exercises: The first group performed balance exercise which last for six weeks, 3 times a week, and 40 minutes each session. Each session started by several minutes of slow walking and progressive stretching of ankle, knee and hip muscles which was gradually increased in time and repetition. After that, balance exercises were performed.
Ankle taping: In second group Ankle joint taping continued for 6 weeks and was renewed three times a week.
arm group label: Balance exrercise and ankle taping
other name: Balance Exercises
other name: Ankle taping
criteria: 
gender: Female
minimum age: 19 Years
maximum age: 22 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Iran, Islamic Republic of
url: http://www.biodex.com
description: The Biodex Balance System SD has been designed to meet the needs of everyone looking to improve balance, increase agility, develop muscle tone and treat a wide variety of pathologies.
citation: Lentell G, Baas B, Lopez D, McGuire L, Sarrels M, Snyder P. The contributions of proprioceptive deficits, muscle function, and anatomic laxity to functional instability of the ankle. J Orthop Sports Phys Ther. 1995 Apr;21(4):206-15. doi: 10.2519/jospt.1995.21.4.206.
PMID: 7773272
responsible party type: Principal Investigator
investigator affiliation: Zahedan University of Medical Sciences
investigator full name: Dr. Asghar Akbari
investigator title: Dr
mesh term: Somatosensory Disorders