<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/NCT04479774</url>
  </required_header>
  <id_info>
    <org_study_id>NWIHS-0001/IRB/01</org_study_id>
    <nct_id>NCT04479774</nct_id>
  </id_info>
  <brief_title>Effects of Compelled Body Weight Shift Technique for Rehabilitation of Individuals With Chronic Stroke</brief_title>
  <official_title>Effects of Compelled Body Weight Shift Technique for Rehabilitation of Individuals With Chronic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwest Institute of Health Sciences, Pakistan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwest Institute of Health Sciences, Pakistan</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Stroke is one of the major cause of lifelong disability if not treated on time, the&#xD;
      investigator's technique knows as Compelled Body Weight Shift Technique (CBWS) was utilized&#xD;
      and administered to chronic stroke population and results were figured out using gait&#xD;
      parameters and Tinetti POMA scale.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Total 28 sample size out of which 27 were divided into control and experimental group.&#xD;
      Inclusion criteria was Unilateral chronic stroke with asymmetrical stance, Patients with&#xD;
      score of 3,4 and 5 will be included according to FAS (Functional Ambulation Scale), Ability&#xD;
      to understand and follow instructions, Both male and female, Any type of stroke, and Age&#xD;
      40-60. Written and informed consent was obtained from participants of study. Six weeks of&#xD;
      exercise training was combined with compelled body weight shift technique via shoe lift of&#xD;
      0.6 cm thickness for experimental group and for control group training was performed without&#xD;
      shoe lift.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 12, 2020</start_date>
  <completion_date type="Actual">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">August 29, 2020</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>
    <intervention_model_description>Participants random allocation into control and experimental groups</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tinetti Performance Oriented Mobility Assessment</measure>
    <time_frame>upto 6 weeks</time_frame>
    <description>Tinetti Performance Oriented Mobility Assessment The Tinetti, evaluation instrument is, an effectively managed, task-arranged test that, quantifies gait and balance activities of patients. A three-point, ordinal scale, extending from 0-2. &quot;0&quot; demonstrates the most elevated level of debilitation and &quot;2&quot; the people's freedom.&#xD;
Total Balance Score = 16&#xD;
Total Gait Score = 12&#xD;
Maximum total test Score = 28 [Time Frame: upto 6 weeks]</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>A 10meter walk test</measure>
    <time_frame>upto 6 weeks</time_frame>
    <description>A 10meter walk test A ten meter distance employed, to determine functional mobility and gait speed, the ten meter walk test was performed by patient at self-selected walking pace and fast walking pace</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Camry 160 Analog Weight Scale</measure>
    <time_frame>upto 6 weeks</time_frame>
    <description>Camry 160 Analog Weight Scale to check the weight in kilograms</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Chronic Stroke</condition>
  <arm_group>
    <arm_group_label>Experimental Group (Group A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects were randomly assigned and informed consent was obtained, the subjects were educated about treatment and on the basis of functional ambulation scale 3,4 and 5 subjects were included, along with this the subjects of age group between 40-60 having ability to understand and follow instructions were included in study.&#xD;
Results were obtained by using gait parameters including walk speed, cadence, step rate, stride length The tinetti POMA scale was utilized to record changes post treatment in gait , the weight bearing was recorded using Camry ZT-160 analog weight scale At the end of every week results were obtained.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group: (Group B)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects were randomly assigned and informed consent was obtained, the subjects were educated about treatment and on the basis of functional ambulation scale 3,4 and 5 subjects were included, along with this the subjects of age group between 40-60 having ability to understand and follow instructions were included in study.&#xD;
Results were obtained by using gait parameters including walk speed, cadence, step rate, stride length The tinetti POMA scale was utilized to record changes post treatment in gait , the weight bearing was recorded using Camry ZT-160 analog weight scale At the end of every week results were obtained.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Compelled Body Weight Shift Technique</intervention_name>
    <description>Routine Physical Therapy with 0.6 cm thickness insole inserted in shoe of unaffected side and following exercises were performed by patients&#xD;
Muscle re-education&#xD;
Sit to stand exercise , 4 to 10 repetitions&#xD;
Supported heel raise to 10 repetitions with 3 sets&#xD;
Supported squat exercise tibialis anterior and quads muscles to 10 repetitions with 3 sets&#xD;
Gait training&#xD;
Forward walk in parallel bars with number of 10 rounds.&#xD;
Task oriented training balance training&#xD;
A. Stepping exercise on 15 cm height step and number of repetitions 10.&#xD;
B. Tandem standing for 10 seconds.&#xD;
C. Reaching exercise in which patient performed reaching for object in therapists hand and the number of repetitions was 10.</description>
    <arm_group_label>Experimental Group (Group A)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Compelled Body Weight Shift Technique without insole</intervention_name>
    <description>Routine Physical Therapy without 0.6 cm thickness insole inserted in shoe of unaffected side and following exercises were performed by patients&#xD;
Muscle re-education&#xD;
Sit to stand exercise , 4 to 10 repetitions&#xD;
Supported heel raise to 10 repetitions with 3 sets&#xD;
Supported squat exercise tibialis anterior and quads muscles to 10 repetitions with 3 sets&#xD;
Gait training&#xD;
Forward walk in parallel bars with number of 10 rounds.&#xD;
Task oriented training balance training&#xD;
A. Stepping exercise on 15 cm height step and number of repetitions 10.&#xD;
B. Tandem standing for 10 seconds.&#xD;
C. Reaching exercise in which patient performed reaching for object in therapists hand and the number of repetitions was 10.</description>
    <arm_group_label>Control group: (Group B)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unilateral chronic stroke with asymmetrical stance&#xD;
&#xD;
          -  Patients with score of 3,4 and 5 were included according to functional ambulation&#xD;
             scale(59)&#xD;
&#xD;
          -  Ability to understand and follow instruction&#xD;
&#xD;
          -  Both male and female.&#xD;
&#xD;
          -  Any type of stroke.&#xD;
&#xD;
          -  Age 40-60.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Serious or unstable medical, condition of patient.&#xD;
&#xD;
               -  History of other neurological diseases (i.e. Parkinson's disease, multiple&#xD;
                  sclerosis),&#xD;
&#xD;
               -  Contractures or any deformity.&#xD;
&#xD;
               -  Leg Length Discrepancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Usman Farooq, Mspt</name>
      <address>
        <city>Peshawar</city>
        <state>KP</state>
        <zip>25000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>September 1, 2020</last_update_submitted>
  <last_update_submitted_qc>September 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwest Institute of Health Sciences, Pakistan</investigator_affiliation>
    <investigator_full_name>Usman Farooq</investigator_full_name>
    <investigator_title>Dr.Usman Farooq PT</investigator_title>
  </responsible_party>
  <keyword>compelled body shift technique</keyword>
  <keyword>stroke</keyword>
  <keyword>tinetti performance oriented mobility assessment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Body Weight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
  </patient_data>
  <!-- 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/NCT04479774
org study id: NWIHS-0001/IRB/01
nct id: NCT04479774
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Stroke is one of the major cause of lifelong disability if not treated on time, the
      investigator's technique knows as Compelled Body Weight Shift Technique (CBWS) was utilized
      and administered to chronic stroke population and results were figured out using gait
      parameters and Tinetti POMA scale.
Total 28 sample size out of which 27 were divided into control and experimental group.
      Inclusion criteria was Unilateral chronic stroke with asymmetrical stance, Patients with
      score of 3,4 and 5 will be included according to FAS (Functional Ambulation Scale), Ability
      to understand and follow instructions, Both male and female, Any type of stroke, and Age
      40-60. Written and informed consent was obtained from participants of study. Six weeks of
      exercise training was combined with compelled body weight shift technique via shoe lift of
      0.6 cm thickness for experimental group and for control group training was performed without
      shoe lift.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants random allocation into control and experimental groups
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Tinetti Performance Oriented Mobility Assessment
time frame: upto 6 weeks
description: Tinetti Performance Oriented Mobility Assessment The Tinetti, evaluation instrument is, an effectively managed, task-arranged test that, quantifies gait and balance activities of patients. A three-point, ordinal scale, extending from 0-2. "0" demonstrates the most elevated level of debilitation and "2" the people's freedom.
Total Balance Score = 16
Total Gait Score = 12
Maximum total test Score = 28 [Time Frame: upto 6 weeks]
measure: A 10meter walk test
time frame: upto 6 weeks
description: A 10meter walk test A ten meter distance employed, to determine functional mobility and gait speed, the ten meter walk test was performed by patient at self-selected walking pace and fast walking pace
measure: Camry 160 Analog Weight Scale
time frame: upto 6 weeks
description: Camry 160 Analog Weight Scale to check the weight in kilograms
arm group label: Experimental Group (Group A)
arm group type: Experimental
description: Subjects were randomly assigned and informed consent was obtained, the subjects were educated about treatment and on the basis of functional ambulation scale 3,4 and 5 subjects were included, along with this the subjects of age group between 40-60 having ability to understand and follow instructions were included in study.
Results were obtained by using gait parameters including walk speed, cadence, step rate, stride length The tinetti POMA scale was utilized to record changes post treatment in gait , the weight bearing was recorded using Camry ZT-160 analog weight scale At the end of every week results were obtained.
arm group label: Control group: (Group B)
arm group type: Other
description: Subjects were randomly assigned and informed consent was obtained, the subjects were educated about treatment and on the basis of functional ambulation scale 3,4 and 5 subjects were included, along with this the subjects of age group between 40-60 having ability to understand and follow instructions were included in study.
Results were obtained by using gait parameters including walk speed, cadence, step rate, stride length The tinetti POMA scale was utilized to record changes post treatment in gait , the weight bearing was recorded using Camry ZT-160 analog weight scale At the end of every week results were obtained.
intervention type: Other
intervention name: Compelled Body Weight Shift Technique
description: Routine Physical Therapy with 0.6 cm thickness insole inserted in shoe of unaffected side and following exercises were performed by patients
Muscle re-education
Sit to stand exercise , 4 to 10 repetitions
Supported heel raise to 10 repetitions with 3 sets
Supported squat exercise tibialis anterior and quads muscles to 10 repetitions with 3 sets
Gait training
Forward walk in parallel bars with number of 10 rounds.
Task oriented training balance training
A. Stepping exercise on 15 cm height step and number of repetitions 10.
B. Tandem standing for 10 seconds.
C. Reaching exercise in which patient performed reaching for object in therapists hand and the number of repetitions was 10.
arm group label: Experimental Group (Group A)
intervention type: Other
intervention name: Compelled Body Weight Shift Technique without insole
description: Routine Physical Therapy without 0.6 cm thickness insole inserted in shoe of unaffected side and following exercises were performed by patients
Muscle re-education
Sit to stand exercise , 4 to 10 repetitions
Supported heel raise to 10 repetitions with 3 sets
Supported squat exercise tibialis anterior and quads muscles to 10 repetitions with 3 sets
Gait training
Forward walk in parallel bars with number of 10 rounds.
Task oriented training balance training
A. Stepping exercise on 15 cm height step and number of repetitions 10.
B. Tandem standing for 10 seconds.
C. Reaching exercise in which patient performed reaching for object in therapists hand and the number of repetitions was 10.
arm group label: Control group: (Group B)
criteria: 
gender: All
minimum age: 40 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Northwest Institute of Health Sciences, Pakistan
investigator full name: Usman Farooq
investigator title: Dr.Usman Farooq PT
mesh term: Stroke
mesh term: Body Weight
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code