<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/NCT02232295</url>
  </required_header>
  <id_info>
    <org_study_id>M44-124</org_study_id>
    <nct_id>NCT02232295</nct_id>
  </id_info>
  <brief_title>A Clinical Trial to Study the Effect of Imagined Progressive Movements in Patients With Paralysis of One Side of the Body.</brief_title>
  <official_title>To Study the Effect of Graded Motor Imagery on Upper Limb Motor Functions and Quality of Life in Patients With Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maharishi Markendeswar University (Deemed to be University)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maharishi Markendeswar University (Deemed to be University)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the Study to evaluate the effect of Graded motor imagery on upper limb motor&#xD;
      functions and quality of life in patients with stroke that was conducted in two centers in&#xD;
      india. The primary outcome measures were upper limb motor functions at 6 weeks and secondary&#xD;
      outcome measure was quality of life at 6 weeks.&#xD;
&#xD;
      Research Hypothesis: There would be significant effect of GMI on Upper limb motor functions&#xD;
      and quality of life in patients with stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Graded Motor Imagery (GMI) is essentially a brain based treatment, targeting the activation&#xD;
      of different brain regions in a graded manner. GMI is a three stage treatment programme&#xD;
      comprising of Left Right discrimination training, Explicit Motor imagery and Mirror therapy.&#xD;
&#xD;
      In this Study, GMI approach is applied on the patients with Stroke to enhance their Upper&#xD;
      limb motor functions and Quality of life.&#xD;
&#xD;
      Conventional treatment:&#xD;
&#xD;
      Patients of group A and group B had received conventional treatment for 6 weeks. Conventional&#xD;
      treatment consists of Task oriented upper extremity functional exercises. Components of Task&#xD;
      oriented training include weight bearing, supportive reactions, and reaching, grasping,&#xD;
      holding and release activities. It was performed five days a week for six weeks of one hour&#xD;
      duration.&#xD;
&#xD;
      Graded Motor Imagery:&#xD;
&#xD;
      Patients of group A had received GMI programme with conventional treatment for 6 weeks. It is&#xD;
      a three stage process, was performed five days a week for six weeks of one hour duration. It&#xD;
      comprises of:&#xD;
&#xD;
        -  Left Right discrimination training (Implicit Motor Imagery) - 2 weeks&#xD;
&#xD;
        -  Explicit Motor Imagery (Imagined movements) - 2 weeks&#xD;
&#xD;
        -  Mirror Therapy - 2 weeks&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">March 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Upper limb motor functions</measure>
    <time_frame>six weeks</time_frame>
    <description>Primary Outcome measures: FMA Scale and CAHAI scale&#xD;
FMA Scale:&#xD;
It is a stroke specific, performance based impairment index. This scale includes items related to movements of the shoulder, elbow, forearm, wrist, and hand in the upper extremity, as well as the hip, knee, and ankle in the lower extremity. For the present study, only the upper extremity was measured.The total score on the upper extremity part of the FMA ranged from 0 (hemiplegia) to a maximum of 66 points (normal motor performance). The scale was measured at baseline and post intervention.&#xD;
CAHAI Scale:&#xD;
The purpose of this measure is to evaluate the functional ability of the hemiplegic arm and hand to perform tasks. It is designed to encourage the bilateral hand to complete the task.Each task was demonstrated once before performance, then the Score was evaluated of the affected upper extremity using the 7 point activity scale from total assistance (1) to complete</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>6 weeks</time_frame>
    <description>Secondary outcome measure:&#xD;
SS-QOL (Stroke Specific- Quality of life) Scale It is a self report scale containing 49 items in 12 domains. It is intended to provide an assessment of health related quality of life specific to patients with stroke. Scale domains and items were derived from a series of interviews with patients.The scale was measured at baseline and post intervention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Conventional group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional group consist of Upper extremity task oriented functional exercises. Components of Task oriented training include weight bearing, supportive reactions, and reaching, grasping, holding and release activities.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Graded Motor imagery group and Conventional group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Graded Motor imagery is a three stage process, was performed five days a week for six weeks of one hour duration. It comprises of:&#xD;
Left Right discrimination training (Implicit Motor Imagery) - 2 weeks&#xD;
Explicit Motor Imagery (Imagined movements) - 2 weeks&#xD;
Mirror Therapy - 2 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Recognise [TM]</intervention_name>
    <description>Recognise accurately measures to identify left and right body parts and movements, and to train left/right discrimination as part of a comprehensive GMI rehabilitation process.</description>
    <arm_group_label>Graded Motor imagery group and Conventional group</arm_group_label>
    <other_name>Online Recognise software by the NOI group, Australia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mirror Box</intervention_name>
    <description>A resource used for many pain and disability states of the hands and feet.</description>
    <arm_group_label>Conventional group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age (between 45 to 65 years)&#xD;
&#xD;
          -  Individuals who experienced one episode of stroke only.&#xD;
&#xD;
          -  Both males and females were included in the study&#xD;
&#xD;
          -  Both ischemic &amp; haemorrhagic stroke individuals were included in the study&#xD;
&#xD;
          -  Duration of stroke between 1 to 6 months&#xD;
&#xD;
          -  Mini mental status examination (MMSE) (score &gt; 23)&#xD;
&#xD;
          -  Patients with Brunnstrom stage 1 &amp; 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals having any musculoskeletal disorders&#xD;
&#xD;
          -  Individuals having any neurological disorder other than stroke&#xD;
&#xD;
          -  Individuals with any visual impairment&#xD;
&#xD;
          -  Individuals having any systemic disease&#xD;
&#xD;
          -  Non cooperative patients&#xD;
&#xD;
          -  Patients suffering from psychological problems&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Manisha Uttam, Masters in Physiotherapy</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maharishi Markandeshwar University, Mullana-Ambala</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maharishi Markandeshwar institute of Physiotherapy and rehabilitation, MMU, Mullana</name>
      <address>
        <city>Ambala</city>
        <state>Haryana</state>
        <zip>133207</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>September 4, 2014</last_update_submitted>
  <last_update_submitted_qc>September 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Maharishi Markendeswar University (Deemed to be University)</investigator_affiliation>
    <investigator_full_name>Manisha Uttam</investigator_full_name>
    <investigator_title>Physiotherapist</investigator_title>
  </responsible_party>
  <keyword>Upper extremity, motor imagery, mirror therapy</keyword>
  <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/NCT02232295
org study id: M44-124
nct id: NCT02232295
lead sponsor: 
has dmc: Yes
The aim of the Study to evaluate the effect of Graded motor imagery on upper limb motor
      functions and quality of life in patients with stroke that was conducted in two centers in
      india. The primary outcome measures were upper limb motor functions at 6 weeks and secondary
      outcome measure was quality of life at 6 weeks.

      Research Hypothesis: There would be significant effect of GMI on Upper limb motor functions
      and quality of life in patients with stroke.
Graded Motor Imagery (GMI) is essentially a brain based treatment, targeting the activation
      of different brain regions in a graded manner. GMI is a three stage treatment programme
      comprising of Left Right discrimination training, Explicit Motor imagery and Mirror therapy.

      In this Study, GMI approach is applied on the patients with Stroke to enhance their Upper
      limb motor functions and Quality of life.

      Conventional treatment:

      Patients of group A and group B had received conventional treatment for 6 weeks. Conventional
      treatment consists of Task oriented upper extremity functional exercises. Components of Task
      oriented training include weight bearing, supportive reactions, and reaching, grasping,
      holding and release activities. It was performed five days a week for six weeks of one hour
      duration.

      Graded Motor Imagery:

      Patients of group A had received GMI programme with conventional treatment for 6 weeks. It is
      a three stage process, was performed five days a week for six weeks of one hour duration. It
      comprises of:

        -  Left Right discrimination training (Implicit Motor Imagery) - 2 weeks

        -  Explicit Motor Imagery (Imagined movements) - 2 weeks

        -  Mirror Therapy - 2 weeks
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Upper limb motor functions
time frame: six weeks
description: Primary Outcome measures: FMA Scale and CAHAI scale
FMA Scale:
It is a stroke specific, performance based impairment index. This scale includes items related to movements of the shoulder, elbow, forearm, wrist, and hand in the upper extremity, as well as the hip, knee, and ankle in the lower extremity. For the present study, only the upper extremity was measured.The total score on the upper extremity part of the FMA ranged from 0 (hemiplegia) to a maximum of 66 points (normal motor performance). The scale was measured at baseline and post intervention.
CAHAI Scale:
The purpose of this measure is to evaluate the functional ability of the hemiplegic arm and hand to perform tasks. It is designed to encourage the bilateral hand to complete the task.Each task was demonstrated once before performance, then the Score was evaluated of the affected upper extremity using the 7 point activity scale from total assistance (1) to complete
measure: Quality of life
time frame: 6 weeks
description: Secondary outcome measure:
SS-QOL (Stroke Specific- Quality of life) Scale It is a self report scale containing 49 items in 12 domains. It is intended to provide an assessment of health related quality of life specific to patients with stroke. Scale domains and items were derived from a series of interviews with patients.The scale was measured at baseline and post intervention.
arm group label: Conventional group
arm group type: Active Comparator
description: Conventional group consist of Upper extremity task oriented functional exercises. Components of Task oriented training include weight bearing, supportive reactions, and reaching, grasping, holding and release activities.
arm group label: Graded Motor imagery group and Conventional group
arm group type: Experimental
description: Graded Motor imagery is a three stage process, was performed five days a week for six weeks of one hour duration. It comprises of:
Left Right discrimination training (Implicit Motor Imagery) - 2 weeks
Explicit Motor Imagery (Imagined movements) - 2 weeks
Mirror Therapy - 2 weeks
intervention type: Device
intervention name: Recognise [TM]
description: Recognise accurately measures to identify left and right body parts and movements, and to train left/right discrimination as part of a comprehensive GMI rehabilitation process.
arm group label: Graded Motor imagery group and Conventional group
other name: Online Recognise software by the NOI group, Australia
intervention type: Device
intervention name: Mirror Box
description: A resource used for many pain and disability states of the hands and feet.
arm group label: Conventional group
criteria: 
gender: All
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: No
last name: Manisha Uttam, Masters in Physiotherapy
role: Principal Investigator
affiliation: Maharishi Markandeshwar University, Mullana-Ambala
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Maharishi Markendeswar University (Deemed to be University)
investigator full name: Manisha Uttam
investigator title: Physiotherapist
mesh term: Stroke