<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/NCT03234426</url>
  </required_header>
  <id_info>
    <org_study_id>MGM ECRHS 2014/160</org_study_id>
    <nct_id>NCT03234426</nct_id>
  </id_info>
  <brief_title>Effectiveness of Perturbations Exercises in Improving Balance, Function and Mobility in Stroke Patients</brief_title>
  <acronym>perturbation</acronym>
  <official_title>Effectiveness of Perturbations Exercises in Improving Balance, Function and Mobility in Stroke Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahatma Gandhi Institute of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahatma Gandhi Institute of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Following stroke, patients loses functions of the motor, sensory and higher brain cognitive&#xD;
      faculties to various degrees which lead to diminished balance. It has been documented that&#xD;
      hemiplegic or hemiparetic stroke patients presented with more posture sway, asymmetric weight&#xD;
      distribution, impaired weight-shifting ability and decreased stability capability. There are&#xD;
      many balance exercises and strategies; to improve balance in elderly age group population, to&#xD;
      prevent fall prevention. But we have very few evidences of giving manual perturbation balance&#xD;
      training in stroke patients to improve speed, balance and function. Therefore this study is&#xD;
      taken up to examine whether the manual perturbation balance training is more effective in&#xD;
      improving speed, balance and function in stroke patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are many more studies done for elderly populations, normal individuals for improving&#xD;
      balance by giving perturbation based balance training.All perturbation exercises are given by&#xD;
      either mechanical or by self reaching tasks in forward,backward,and in both sideways. There&#xD;
      are very studies ;who attempted perturbation based balance training to improve balance in&#xD;
      elderly population but not for stroke patients for their Speed, Balance and Function.The&#xD;
      manual perturbation exercise can be an promising intervention in the future for various&#xD;
      conditions&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Berg Balance Scale</measure>
    <time_frame>4 weeks</time_frame>
    <description>patients ability of balance were assessed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional Independence Scale</measure>
    <time_frame>4 weeks</time_frame>
    <description>ability of Functional independent level for Activity Of Daily Living were assessed</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Timed Up and Go Test</measure>
    <time_frame>4 weeks</time_frame>
    <description>patient's speed for performing Activity Of Daily Living were assessed by this test</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>manual perturbations were given in forward, Backward,right and left sideways, 10 perturbations were given,6 days in week,in fallowing positions- sitting,kneeling, standing positions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Conventional Physiotherapy were given 6 days in a week, for 30 mins for 4 weeks, includes stretching, strengthening of contralateral limbs</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Perturbation</intervention_name>
    <description>Manual perturbations were given at waist region,over the Shoulders. in following positions- sitting, kneeling, standing positions,10 perturbations were given in forward,backward,both right and left side, 6 days in a week all precautionary measures taken for the patient's safety</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Experimental Group</arm_group_label>
    <other_name>Manual Perturbation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional Physiotherapy Treatment</intervention_name>
    <description>Conventional Physiotherapy treatment were given to participants included in this group for 30 mins daily for 4 weeks</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Experimental Group</arm_group_label>
    <other_name>control Group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. First ever stroke&#xD;
&#xD;
          2. Age ranges between 40-70&#xD;
&#xD;
          3. Both genders were included&#xD;
&#xD;
          4. Ambulatory patients with or without ambulatory aids&#xD;
&#xD;
          5. Occurrence of stroke at within 0-3 months i.e.-sub acute&#xD;
&#xD;
          6. Able to follow command&#xD;
&#xD;
          7. Mini mental scale examinations not less than 24&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who has severe limitations in passive range of motion at lower extremities&#xD;
&#xD;
          2. Patients with impaired sensory, proprioceptor, cognitive and perceptual ability&#xD;
&#xD;
          3. Patient who has contracture&#xD;
&#xD;
          4. Orthopedic or any other neurological disorder which impair balance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nawaj Pathan, PG student</last_name>
    <role>Principal Investigator</role>
    <affiliation>MGM School Of Physiotherapy,Aurangabad,Maharashtra, India</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MGM school Of Physiotherapy</name>
      <address>
        <city>Aurangabad</city>
        <state>Maharashtra</state>
        <zip>431003</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>December 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>July 26, 2017</last_update_submitted>
  <last_update_submitted_qc>July 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mahatma Gandhi Institute of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Nawaj Pathan</investigator_full_name>
    <investigator_title>M.P.Th.PG student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT03234426
org study id: MGM ECRHS 2014/160
nct id: NCT03234426
lead sponsor: 
has dmc: Yes
Following stroke, patients loses functions of the motor, sensory and higher brain cognitive
      faculties to various degrees which lead to diminished balance. It has been documented that
      hemiplegic or hemiparetic stroke patients presented with more posture sway, asymmetric weight
      distribution, impaired weight-shifting ability and decreased stability capability. There are
      many balance exercises and strategies; to improve balance in elderly age group population, to
      prevent fall prevention. But we have very few evidences of giving manual perturbation balance
      training in stroke patients to improve speed, balance and function. Therefore this study is
      taken up to examine whether the manual perturbation balance training is more effective in
      improving speed, balance and function in stroke patients.
There are many more studies done for elderly populations, normal individuals for improving
      balance by giving perturbation based balance training.All perturbation exercises are given by
      either mechanical or by self reaching tasks in forward,backward,and in both sideways. There
      are very studies ;who attempted perturbation based balance training to improve balance in
      elderly population but not for stroke patients for their Speed, Balance and Function.The
      manual perturbation exercise can be an promising intervention in the future for various
      conditions
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Berg Balance Scale
time frame: 4 weeks
description: patients ability of balance were assessed
measure: Functional Independence Scale
time frame: 4 weeks
description: ability of Functional independent level for Activity Of Daily Living were assessed
measure: Timed Up and Go Test
time frame: 4 weeks
description: patient's speed for performing Activity Of Daily Living were assessed by this test
arm group label: Experimental Group
arm group type: Experimental
description: manual perturbations were given in forward, Backward,right and left sideways, 10 perturbations were given,6 days in week,in fallowing positions- sitting,kneeling, standing positions
arm group label: Control group
arm group type: Placebo Comparator
description: Conventional Physiotherapy were given 6 days in a week, for 30 mins for 4 weeks, includes stretching, strengthening of contralateral limbs
intervention type: Other
intervention name: Perturbation
description: Manual perturbations were given at waist region,over the Shoulders. in following positions- sitting, kneeling, standing positions,10 perturbations were given in forward,backward,both right and left side, 6 days in a week all precautionary measures taken for the patient's safety
arm group label: Control group
arm group label: Experimental Group
other name: Manual Perturbation
intervention type: Other
intervention name: Conventional Physiotherapy Treatment
description: Conventional Physiotherapy treatment were given to participants included in this group for 30 mins daily for 4 weeks
arm group label: Control group
arm group label: Experimental Group
other name: control Group
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nawaj Pathan, PG student
role: Principal Investigator
affiliation: MGM School Of Physiotherapy,Aurangabad,Maharashtra, India
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Mahatma Gandhi Institute of Medical Sciences
investigator full name: Nawaj Pathan
investigator title: M.P.Th.PG student
mesh term: Stroke