xml: <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/NCT05985603</url>
    </required_header>
    <id_info>
      <org_study_id>REC/00234 Bakhtawar Tariq</org_study_id>
      <nct_id>NCT05985603</nct_id>
    </id_info>
    <brief_title>Comparison of Mirror Therapy and Modified Constrain Induced Movement Therapy on Risk of Fall, Balance and Gait in Stroke</brief_title>
    <official_title>Comparison of Mirror Therapy and Modified Constrain Induced Movement Therapy on Risk of Fall, Balance and Gait in Stroke</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Riphah International University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Riphah International University</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>
        There will be a difference between modified constraint induced movement therapy and Mirror&#xD;
        Therapy on lower limb for risk of fall, balance and gait in stroke patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 1, 2023</start_date>
    <completion_date type="Anticipated">February 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 30, 2024</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>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>NIH Stroke Scale - NIHSS</measure>
      <time_frame>2,4,8 week</time_frame>
      <description>It comprises of 15 items with each having responses scored on a 0-4 points scale. The overall score ranges from 0-42 points with higher scores specifying pronounced neurological deficits</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mini-mental state examination</measure>
      <time_frame>2,4,8 week</time_frame>
      <description>Cognitive status by the mini-mental state examination (mmse)Mini-Mental State Examination (MMSE) is a tool that can quickly diagnose if a person suffers from mild cognitive impairment (MCI) through answering questions in different cognitive domains. The MMSE demonstrates moderately high levels of reliability. It has been reported to be internally consistent</description>
    </primary_outcome>
    <primary_outcome>
      <measure>POMA</measure>
      <time_frame>2,4,8 week</time_frame>
      <description>After interventions POMA for assessing risk of fall will be used. The POMA is used to examine balance and mobility in the elderly (Tinetti 1986). This examination tool consists of the balance subscale (9 items, 16 points) and gait subscale (8 items, 12 points), totaling 28 points.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Berg balance scale</measure>
      <time_frame>2,4,8 week</time_frame>
      <description>A five-point scale, ranging from 0-4. &quot;0&quot; indicates the lowest level of function and &quot;4&quot; the highest level of function. Total Score = 0-56. Score of 41-56 = low fall risk, 21-40 = medium fall risk, 0-20 = high fall risk.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>10 Meter walk test / 10mwt</measure>
      <time_frame>2,4,8 week</time_frame>
      <description>Calculating Gait Speed - total distance/time. For example: if you did a 10-meter gait speed test and it took you 7 seconds, the equation would like: 10 meters / 7 seconds = 1.4 meters per second. The 10MWT intra-rater and inter-rater reliability were good (ICC between 0.76 until 0.9) and excellent (ICC &gt; 0.9), respectively. The minimal detectable change for intra-rater reliability was 0.188 m/s.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">36</enrollment>
    <condition>Stroke</condition>
    <arm_group>
      <arm_group_label>CIMT Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In this group of patients CIMT technique will be used for treatment</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Mirror Therapy Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>patient will perform movements in semi-reclined and sitting positions with the mirror placed between the two lower extremities.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>CIMT Group</intervention_name>
      <description>In this group of patients CIMT technique will be used for treatment</description>
      <arm_group_label>CIMT Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Mirror Therapy group</intervention_name>
      <description>patient will perform movements in semi-reclined and sitting positions with the mirror placed between the two lower extremities.</description>
      <arm_group_label>Mirror Therapy Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  A Hemiplegia due to unilateral stroke&#xD;
  &#xD;
            -  Sub-acute and chronic stroke&#xD;
  &#xD;
            -  Stroke survivors between 21 and 70 years old will be recruited&#xD;
  &#xD;
            -  Both genders&#xD;
  &#xD;
            -  NIH Stroke scale below 20&#xD;
  &#xD;
            -  Mini-Mental State Examination above 24&#xD;
  &#xD;
            -  Function in Sitting Test (FIST) above 42/56&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with depression who will be unable to cooperate during treatment&#xD;
  &#xD;
            -  Patients who cannot perform the active movement of limb due to prestroke muscoskeletal&#xD;
               problems&#xD;
  &#xD;
            -  Cardiopulmonary diseases which could hinder their ability to participate in&#xD;
               rehabilitation&#xD;
  &#xD;
            -  Spasticity of Modified Ashworth Scale (MAS) II or higher&#xD;
  &#xD;
            -  Patients with Any neuron disease and Patients with lower-limb impairment caused by&#xD;
               other neurological diseases or inability to comply with study protocol will be&#xD;
               excluded.&#xD;
  &#xD;
            -  Visual and auditory abnormalities&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ayesha Bashir, MS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Riphah International University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ayesha Bashir</last_name>
      <phone>03335256920</phone>
      <email>ayesha.bashir@riphah.edu.pk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Helping Hand Institute Of rehabilitation sciences</name>
        <address>
          <city>Mansehra</city>
          <state>KPK</state>
          <zip>21300</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ayesha Basheer, MSNMPT</last_name>
        <phone>+92 333 5256920</phone>
        <email>ayesha.bashir@riphah.edu.pk</email>
      </contact>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <reference>
      <citation>Oh K, Im N, Lee Y, Lim N, Cho T, Ryu S, Yoon S. Effect of Antigravity Treadmill Gait Training on Gait Function and Fall Risk in Stroke Patients. Ann Rehabil Med. 2022 Jun;46(3):114-121. doi: 10.5535/arm.22034. Epub 2022 Jun 30.</citation>
      <PMID>35793900</PMID>
    </reference>
    <reference>
      <citation>Okonkwo UP, Agbo CF, Ibeneme SC, Igwe ES, Akosile CO, Onwuakagba IU, Emmanuel OC, Maduagwu SM, Ezenwankwo EF, Ekechukwu EN. The Burden and Quality of life of Caregivers of Stroke Survivors with Cognitive Impairment in Selected Healthcare Facilities in Anambra State, Nigeria. Gerontol Geriatr Med. 2022 Sep 27;8:23337214221126329. doi: 10.1177/23337214221126329. eCollection 2022 Jan-Dec.</citation>
      <PMID>36189374</PMID>
    </reference>
    <reference>
      <citation>Wagatsuma M, Kim T, Sitagata P, Lee E, Vrongistinos K, Jung T. The biomechanical investigation of the relationship between balance and muscular strength in people with chronic stroke: a pilot cross-sectional study. Top Stroke Rehabil. 2019 Apr;26(3):173-179. doi: 10.1080/10749357.2019.1574417. Epub 2019 Feb 11.</citation>
      <PMID>30741610</PMID>
    </reference>
    <reference>
      <citation>Khan F, Abusharha S, Alfuraidy A, Nimatallah K, Almalki R, Basaffar R, Mirdad M, Chevidikunnan MF, Basuodan R. Prediction of Factors Affecting Mobility in Patients with Stroke and Finding the Mediation Effect of Balance on Mobility: A Cross-Sectional Study. Int J Environ Res Public Health. 2022 Dec 10;19(24):16612. doi: 10.3390/ijerph192416612.</citation>
      <PMID>36554493</PMID>
    </reference>
    <reference>
      <citation>Li J, Zhong D, Ye J, He M, Liu X, Zheng H, Jin R, Zhang SL. Rehabilitation for balance impairment in patients after stroke: a protocol of a systematic review and network meta-analysis. BMJ Open. 2019 Jul 19;9(7):e026844. doi: 10.1136/bmjopen-2018-026844.</citation>
      <PMID>31326927</PMID>
    </reference>
    <reference>
      <citation>Arienti C, Lazzarini SG, Pollock A, Negrini S. Rehabilitation interventions for improving balance following stroke: An overview of systematic reviews. PLoS One. 2019 Jul 19;14(7):e0219781. doi: 10.1371/journal.pone.0219781. eCollection 2019.</citation>
      <PMID>31323068</PMID>
    </reference>
    <reference>
      <citation>Herrador Colmenero L, Perez Marmol JM, Marti-Garcia C, Querol Zaldivar MLA, Tapia Haro RM, Castro Sanchez AM, Aguilar-Ferrandiz ME. Effectiveness of mirror therapy, motor imagery, and virtual feedback on phantom limb pain following amputation: A systematic review. Prosthet Orthot Int. 2018 Jun;42(3):288-298. doi: 10.1177/0309364617740230. Epub 2017 Nov 20.</citation>
      <PMID>29153043</PMID>
    </reference>
    <reference>
      <citation>Ju Y, Yoon IJ. The effects of modified constraint-induced movement therapy and mirror therapy on upper extremity function and its influence on activities of daily living. J Phys Ther Sci. 2018 Jan;30(1):77-81. doi: 10.1589/jpts.30.77. Epub 2018 Jan 27.</citation>
      <PMID>29410571</PMID>
    </reference>
    <reference>
      <citation>Garrido M M, Alvarez E E, Acevedo P F, Moyano V A, Castillo N N, Cavada Ch G. Early transcranial direct current stimulation with modified constraint-induced movement therapy for motor and functional upper limb recovery in hospitalized patients with stroke: A randomized, multicentre, double-blind, clinical trial. Brain Stimul. 2023 Jan-Feb;16(1):40-47. doi: 10.1016/j.brs.2022.12.008. Epub 2022 Dec 28.</citation>
      <PMID>36584748</PMID>
    </reference>
    <reference>
      <citation>E Silva EMGS, Ribeiro TS, da Silva TCC, Costa MFP, Cavalcanti FADC, Lindquist ARR. Effects of constraint-induced movement therapy for lower limbs on measurements of functional mobility and postural balance in subjects with stroke: a randomized controlled trial. Top Stroke Rehabil. 2017 Dec;24(8):555-561. doi: 10.1080/10749357.2017.1366011. Epub 2017 Aug 31.</citation>
      <PMID>28859603</PMID>
    </reference>
    <reference>
      <citation>Wang D, Xiang J, He Y, Yuan M, Dong L, Ye Z, Mao W. The Mechanism and Clinical Application of Constraint-Induced Movement Therapy in Stroke Rehabilitation. Front Behav Neurosci. 2022 Jun 21;16:828599. doi: 10.3389/fnbeh.2022.828599. eCollection 2022.</citation>
      <PMID>35801093</PMID>
    </reference>
    <reference>
      <citation>Yoon JA, Koo BI, Shin MJ, Shin YB, Ko HY, Shin YI. Effect of constraint-induced movement therapy and mirror therapy for patients with subacute stroke. Ann Rehabil Med. 2014 Aug;38(4):458-66. doi: 10.5535/arm.2014.38.4.458. Epub 2014 Aug 28.</citation>
      <PMID>25229024</PMID>
    </reference>
    <reference>
      <citation>Kim K, Lee S, Kim D, Lee K, Kim Y. Effects of mirror therapy combined with motor tasks on upper extremity function and activities daily living of stroke patients. J Phys Ther Sci. 2016 Jan;28(2):483-7. doi: 10.1589/jpts.28.483. Epub 2016 Feb 29.</citation>
      <PMID>27065534</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>CIMT</keyword>
    <keyword>Mirror Therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stroke</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05985603
  org study id: REC/00234 Bakhtawar Tariq
  nct id: NCT05985603
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  There will be a difference between modified constraint induced movement therapy and Mirror
        Therapy on lower limb for risk of fall, balance and gait in stroke patients.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: NIH Stroke Scale - NIHSS
  time frame: 2,4,8 week
  description: It comprises of 15 items with each having responses scored on a 0-4 points scale. The overall score ranges from 0-42 points with higher scores specifying pronounced neurological deficits
  measure: Mini-mental state examination
  time frame: 2,4,8 week
  description: Cognitive status by the mini-mental state examination (mmse)Mini-Mental State Examination (MMSE) is a tool that can quickly diagnose if a person suffers from mild cognitive impairment (MCI) through answering questions in different cognitive domains. The MMSE demonstrates moderately high levels of reliability. It has been reported to be internally consistent
  measure: POMA
  time frame: 2,4,8 week
  description: After interventions POMA for assessing risk of fall will be used. The POMA is used to examine balance and mobility in the elderly (Tinetti 1986). This examination tool consists of the balance subscale (9 items, 16 points) and gait subscale (8 items, 12 points), totaling 28 points.
  measure: Berg balance scale
  time frame: 2,4,8 week
  description: A five-point scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Total Score = 0-56. Score of 41-56 = low fall risk, 21-40 = medium fall risk, 0-20 = high fall risk.
  measure: 10 Meter walk test / 10mwt
  time frame: 2,4,8 week
  description: Calculating Gait Speed - total distance/time. For example: if you did a 10-meter gait speed test and it took you 7 seconds, the equation would like: 10 meters / 7 seconds = 1.4 meters per second. The 10MWT intra-rater and inter-rater reliability were good (ICC between 0.76 until 0.9) and excellent (ICC > 0.9), respectively. The minimal detectable change for intra-rater reliability was 0.188 m/s.
  arm group label: CIMT Group
  arm group type: Experimental
  description: In this group of patients CIMT technique will be used for treatment
  arm group label: Mirror Therapy Group
  arm group type: Experimental
  description: patient will perform movements in semi-reclined and sitting positions with the mirror placed between the two lower extremities.
  intervention type: Other
  intervention name: CIMT Group
  description: In this group of patients CIMT technique will be used for treatment
  arm group label: CIMT Group
  intervention type: Other
  intervention name: Mirror Therapy group
  description: patient will perform movements in semi-reclined and sitting positions with the mirror placed between the two lower extremities.
  arm group label: Mirror Therapy Group
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Ayesha Bashir, MS
  role: Principal Investigator
  affiliation: Riphah International University
  last name: Ayesha Bashir
  phone: 03335256920
  email: ayesha.bashir@riphah.edu.pk
  facility: 
  status: Recruiting
  contact: 
  country: Pakistan
  citation: Oh K, Im N, Lee Y, Lim N, Cho T, Ryu S, Yoon S. Effect of Antigravity Treadmill Gait Training on Gait Function and Fall Risk in Stroke Patients. Ann Rehabil Med. 2022 Jun;46(3):114-121. doi: 10.5535/arm.22034. Epub 2022 Jun 30.
  PMID: 35793900
  citation: Okonkwo UP, Agbo CF, Ibeneme SC, Igwe ES, Akosile CO, Onwuakagba IU, Emmanuel OC, Maduagwu SM, Ezenwankwo EF, Ekechukwu EN. The Burden and Quality of life of Caregivers of Stroke Survivors with Cognitive Impairment in Selected Healthcare Facilities in Anambra State, Nigeria. Gerontol Geriatr Med. 2022 Sep 27;8:23337214221126329. doi: 10.1177/23337214221126329. eCollection 2022 Jan-Dec.
  PMID: 36189374
  citation: Wagatsuma M, Kim T, Sitagata P, Lee E, Vrongistinos K, Jung T. The biomechanical investigation of the relationship between balance and muscular strength in people with chronic stroke: a pilot cross-sectional study. Top Stroke Rehabil. 2019 Apr;26(3):173-179. doi: 10.1080/10749357.2019.1574417. Epub 2019 Feb 11.
  PMID: 30741610
  citation: Khan F, Abusharha S, Alfuraidy A, Nimatallah K, Almalki R, Basaffar R, Mirdad M, Chevidikunnan MF, Basuodan R. Prediction of Factors Affecting Mobility in Patients with Stroke and Finding the Mediation Effect of Balance on Mobility: A Cross-Sectional Study. Int J Environ Res Public Health. 2022 Dec 10;19(24):16612. doi: 10.3390/ijerph192416612.
  PMID: 36554493
  citation: Li J, Zhong D, Ye J, He M, Liu X, Zheng H, Jin R, Zhang SL. Rehabilitation for balance impairment in patients after stroke: a protocol of a systematic review and network meta-analysis. BMJ Open. 2019 Jul 19;9(7):e026844. doi: 10.1136/bmjopen-2018-026844.
  PMID: 31326927
  citation: Arienti C, Lazzarini SG, Pollock A, Negrini S. Rehabilitation interventions for improving balance following stroke: An overview of systematic reviews. PLoS One. 2019 Jul 19;14(7):e0219781. doi: 10.1371/journal.pone.0219781. eCollection 2019.
  PMID: 31323068
  citation: Herrador Colmenero L, Perez Marmol JM, Marti-Garcia C, Querol Zaldivar MLA, Tapia Haro RM, Castro Sanchez AM, Aguilar-Ferrandiz ME. Effectiveness of mirror therapy, motor imagery, and virtual feedback on phantom limb pain following amputation: A systematic review. Prosthet Orthot Int. 2018 Jun;42(3):288-298. doi: 10.1177/0309364617740230. Epub 2017 Nov 20.
  PMID: 29153043
  citation: Ju Y, Yoon IJ. The effects of modified constraint-induced movement therapy and mirror therapy on upper extremity function and its influence on activities of daily living. J Phys Ther Sci. 2018 Jan;30(1):77-81. doi: 10.1589/jpts.30.77. Epub 2018 Jan 27.
  PMID: 29410571
  citation: Garrido M M, Alvarez E E, Acevedo P F, Moyano V A, Castillo N N, Cavada Ch G. Early transcranial direct current stimulation with modified constraint-induced movement therapy for motor and functional upper limb recovery in hospitalized patients with stroke: A randomized, multicentre, double-blind, clinical trial. Brain Stimul. 2023 Jan-Feb;16(1):40-47. doi: 10.1016/j.brs.2022.12.008. Epub 2022 Dec 28.
  PMID: 36584748
  citation: E Silva EMGS, Ribeiro TS, da Silva TCC, Costa MFP, Cavalcanti FADC, Lindquist ARR. Effects of constraint-induced movement therapy for lower limbs on measurements of functional mobility and postural balance in subjects with stroke: a randomized controlled trial. Top Stroke Rehabil. 2017 Dec;24(8):555-561. doi: 10.1080/10749357.2017.1366011. Epub 2017 Aug 31.
  PMID: 28859603
  citation: Wang D, Xiang J, He Y, Yuan M, Dong L, Ye Z, Mao W. The Mechanism and Clinical Application of Constraint-Induced Movement Therapy in Stroke Rehabilitation. Front Behav Neurosci. 2022 Jun 21;16:828599. doi: 10.3389/fnbeh.2022.828599. eCollection 2022.
  PMID: 35801093
  citation: Yoon JA, Koo BI, Shin MJ, Shin YB, Ko HY, Shin YI. Effect of constraint-induced movement therapy and mirror therapy for patients with subacute stroke. Ann Rehabil Med. 2014 Aug;38(4):458-66. doi: 10.5535/arm.2014.38.4.458. Epub 2014 Aug 28.
  PMID: 25229024
  citation: Kim K, Lee S, Kim D, Lee K, Kim Y. Effects of mirror therapy combined with motor tasks on upper extremity function and activities daily living of stroke patients. J Phys Ther Sci. 2016 Jan;28(2):483-7. doi: 10.1589/jpts.28.483. Epub 2016 Feb 29.
  PMID: 27065534
  responsible party type: Sponsor
  mesh term: Stroke
  sharing ipd: No