<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/NCT03752788</url>
  </required_header>
  <id_info>
    <org_study_id>RRC-2017-005</org_study_id>
    <nct_id>NCT03752788</nct_id>
  </id_info>
  <brief_title>Dual-Task Training With Different Priority Instructional Sets on the Gait Parameters in Patients With Chronic Stroke</brief_title>
  <official_title>Dual-Task Training With Variable Priority Instructional Sets Improve the Gait Parameters in Patients With Chronic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Saud University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Saud University</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>
      Balance is controlled through a complex process involving sensory, visual, vestibular and&#xD;
      cerebral functioning which get affected by various neurological disorders such as in stroke.&#xD;
      Different types of exercises are designed to target to cope up with the imbalance developed&#xD;
      due to these neurological disorders. This study aimed to compare the efficacy of dual-task&#xD;
      training using two different priority instructional sets in improving gait parameters such as&#xD;
      self-selected velocity, fast speed, step length, and stride length in chronic stroke&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Balance is controlled through a complex process involving sensory, visual, vestibular and&#xD;
      cerebral functioning which get affected by various neurological disorders such as in stroke.&#xD;
      Different types of exercises are designed to target to cope up with the imbalance developed&#xD;
      due to these neurological disorders. This study aimed to compare the efficacy of dual-task&#xD;
      training using two different priority instructional sets in improving gait parameters such as&#xD;
      self-selected velocity, fast speed, step length, and stride length in middle cerebral artery&#xD;
      chronic stroke patients. A total of thirty middle cerebral artery chronic stroke patients&#xD;
      were recruited on the basis of inclusion and exclusion criteria and equally allocated into&#xD;
      two groups. Group 1 received dual-task training with fixed priority instructional sets for&#xD;
      four weeks and group 2 received dual-task training with variable priority instructional sets&#xD;
      for four weeks. The outcome was assessed using a 10-meter walk test and the comparison of&#xD;
      footprints on the walkway paper before and after training.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2017</start_date>
  <completion_date type="Actual">April 23, 2018</completion_date>
  <primary_completion_date type="Actual">November 1, 2017</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>10-meter walk test</measure>
    <time_frame>Change from Baseline 10-meter Walk Test scores at 4-Weeks</time_frame>
    <description>It is used to evaluate gate parameters such as gait velocity (self-selected velocity and fast velocity, step length and stride length ) in patients with chronic stroke.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mini-mental state examination (MMSE) or Folstein test</measure>
    <time_frame>Before the study intervention</time_frame>
    <description>It is used to to determine any impaired cognition that would affect the ability of the participant with stroke to follow instructions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed Up &amp; Go (TUG) test</measure>
    <time_frame>Before the study intervention</time_frame>
    <description>It is used to identify the patient's mobility with respect to healthy elderly subjects, such as the gait parameters and walking endurance in subjects with chronic stroke.The TUG score correlates with gait speed, balance, functional level, ability to go out, and this score can change over time.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Stroke</condition>
  <condition>Middle Cerebral Artery Stroke</condition>
  <condition>Chronic Stroke</condition>
  <arm_group>
    <arm_group_label>Dual-task Training Fixed Priority</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dual-task Training with fixed priority instructional set for four weeks. Balance training sessions of 45 minutes per day, 3 times a week for four weeks, so as to complete 9-12 hours of training warm-up improve the balance performance. This included 12 repetitions in each session for 30 minutes after a 10-minutes warm up.&#xD;
Attention was focused on both postural and cognitive tasks throughout this session. In postural tasks, subjects were instructed to perform the following: walk narrow base of support with a cognitive task of counting backward by three walk narrow base of support with cognitive task of count forward by three, walk narrow base of support, step, sideways, backward avoiding the obstacles (holding a basket) with cognitive task to remember words.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dual-task Training Variable Priority</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dual-task Training with variable priority instructional set for four weeks. Balance training sessions of 45 minutes per day, 3 times a week for four weeks, so as to complete 9-12 hours of training warm-up improve the balance performance. This included 12 repetitions in each session for 30 minutes after a 10-minutes warm up.&#xD;
During the first half of the training session, attention was focused on postural tasks, while during the remaining half of the session, attention was focused on cognitive tasks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dual-task Training Fixed Priority</intervention_name>
    <description>Dual-task training fixed priority instructional set for four weeks. Balance training sessions of 45 minutes per day, 3 times a week for four weeks, so as to complete 9-12 hours of training warm-up improve the balance performance. This included 12 repetitions in each session for 30 minutes after a 10-minutes warm up.&#xD;
Attention was focused on both postural and cognitive tasks throughout this session. In postural tasks, subjects were instructed to perform the following: walk narrow base of support with a cognitive task of counting backward by three walk narrow base of support with cognitive task of count forward by three, walk narrow base of support, step, sideways, backward avoiding the obstacles (holding a basket) with cognitive task to remember words.</description>
    <arm_group_label>Dual-task Training Fixed Priority</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dual-task Training Variable Priority</intervention_name>
    <description>Dual-task training variable priority instructional set for four weeks. Balance training sessions of 45 minutes per day, 3 times a week for four weeks, so as to complete 9-12 hours of training warm-up improve the balance performance. This included 12 repetitions in each session for 30 minutes after a 10-minutes warm up.&#xD;
During the first half of the training session, attention was focused on postural tasks, while during the remaining half of the session, attention was focused on cognitive tasks.</description>
    <arm_group_label>Dual-task Training Variable Priority</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A diagnosed case of middle cerebral artery chronic stroke made by a neurologist and&#xD;
             verified using CT/MRI&#xD;
&#xD;
          -  Exhibited the age between 45 and 65 years&#xD;
&#xD;
          -  Ability to walk 10 meters without assistance&#xD;
&#xD;
          -  Their stroke onset within 12 months prior to the study and&#xD;
&#xD;
          -  Scored greater than 24 on Mini-Mental State Examination (MMSE).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants had neurological conditions other than stroke&#xD;
&#xD;
          -  Uncontrolled hearing or visual and vestibular impairment&#xD;
&#xD;
          -  Took more than 15 seconds on Timed Up &amp; Go (TUG) test&#xD;
&#xD;
          -  Had lower extremity amputation&#xD;
&#xD;
          -  A case of diagnosed speech-language impairment (not able to respond verbally to&#xD;
             auditory stimuli) by a speech-language pathologist and noticed their concurrent&#xD;
             participation in another clinical trial&#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>AMIR IQBAL, MPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rehabilitation Research Chair</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rehabilitation Research Chair</name>
      <address>
        <city>Riyadh</city>
        <zip>11433</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>November 21, 2018</last_update_submitted>
  <last_update_submitted_qc>November 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King Saud University</investigator_affiliation>
    <investigator_full_name>AMIR IQBAL</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Gait velocity</keyword>
  <keyword>Stride length</keyword>
  <keyword>Step length</keyword>
  <keyword>Balance training</keyword>
  <keyword>Dual task</keyword>
  <keyword>Institutional priority sets</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Infarction, Middle Cerebral Artery</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Undecided</ipd_description>
  </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/NCT03752788
org study id: RRC-2017-005
nct id: NCT03752788
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Balance is controlled through a complex process involving sensory, visual, vestibular and
      cerebral functioning which get affected by various neurological disorders such as in stroke.
      Different types of exercises are designed to target to cope up with the imbalance developed
      due to these neurological disorders. This study aimed to compare the efficacy of dual-task
      training using two different priority instructional sets in improving gait parameters such as
      self-selected velocity, fast speed, step length, and stride length in chronic stroke
      patients.
Balance is controlled through a complex process involving sensory, visual, vestibular and
      cerebral functioning which get affected by various neurological disorders such as in stroke.
      Different types of exercises are designed to target to cope up with the imbalance developed
      due to these neurological disorders. This study aimed to compare the efficacy of dual-task
      training using two different priority instructional sets in improving gait parameters such as
      self-selected velocity, fast speed, step length, and stride length in middle cerebral artery
      chronic stroke patients. A total of thirty middle cerebral artery chronic stroke patients
      were recruited on the basis of inclusion and exclusion criteria and equally allocated into
      two groups. Group 1 received dual-task training with fixed priority instructional sets for
      four weeks and group 2 received dual-task training with variable priority instructional sets
      for four weeks. The outcome was assessed using a 10-meter walk test and the comparison of
      footprints on the walkway paper before and after training.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 10-meter walk test
time frame: Change from Baseline 10-meter Walk Test scores at 4-Weeks
description: It is used to evaluate gate parameters such as gait velocity (self-selected velocity and fast velocity, step length and stride length ) in patients with chronic stroke.
measure: Mini-mental state examination (MMSE) or Folstein test
time frame: Before the study intervention
description: It is used to to determine any impaired cognition that would affect the ability of the participant with stroke to follow instructions.
measure: Timed Up & Go (TUG) test
time frame: Before the study intervention
description: It is used to identify the patient's mobility with respect to healthy elderly subjects, such as the gait parameters and walking endurance in subjects with chronic stroke.The TUG score correlates with gait speed, balance, functional level, ability to go out, and this score can change over time.
arm group label: Dual-task Training Fixed Priority
arm group type: Experimental
description: Dual-task Training with fixed priority instructional set for four weeks. Balance training sessions of 45 minutes per day, 3 times a week for four weeks, so as to complete 9-12 hours of training warm-up improve the balance performance. This included 12 repetitions in each session for 30 minutes after a 10-minutes warm up.
Attention was focused on both postural and cognitive tasks throughout this session. In postural tasks, subjects were instructed to perform the following: walk narrow base of support with a cognitive task of counting backward by three walk narrow base of support with cognitive task of count forward by three, walk narrow base of support, step, sideways, backward avoiding the obstacles (holding a basket) with cognitive task to remember words.
arm group label: Dual-task Training Variable Priority
arm group type: Active Comparator
description: Dual-task Training with variable priority instructional set for four weeks. Balance training sessions of 45 minutes per day, 3 times a week for four weeks, so as to complete 9-12 hours of training warm-up improve the balance performance. This included 12 repetitions in each session for 30 minutes after a 10-minutes warm up.
During the first half of the training session, attention was focused on postural tasks, while during the remaining half of the session, attention was focused on cognitive tasks.
intervention type: Behavioral
intervention name: Dual-task Training Fixed Priority
description: Dual-task training fixed priority instructional set for four weeks. Balance training sessions of 45 minutes per day, 3 times a week for four weeks, so as to complete 9-12 hours of training warm-up improve the balance performance. This included 12 repetitions in each session for 30 minutes after a 10-minutes warm up.
Attention was focused on both postural and cognitive tasks throughout this session. In postural tasks, subjects were instructed to perform the following: walk narrow base of support with a cognitive task of counting backward by three walk narrow base of support with cognitive task of count forward by three, walk narrow base of support, step, sideways, backward avoiding the obstacles (holding a basket) with cognitive task to remember words.
arm group label: Dual-task Training Fixed Priority
intervention type: Behavioral
intervention name: Dual-task Training Variable Priority
description: Dual-task training variable priority instructional set for four weeks. Balance training sessions of 45 minutes per day, 3 times a week for four weeks, so as to complete 9-12 hours of training warm-up improve the balance performance. This included 12 repetitions in each session for 30 minutes after a 10-minutes warm up.
During the first half of the training session, attention was focused on postural tasks, while during the remaining half of the session, attention was focused on cognitive tasks.
arm group label: Dual-task Training Variable Priority
criteria: 
gender: All
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: No
last name: AMIR IQBAL, MPT
role: Principal Investigator
affiliation: Rehabilitation Research Chair
facility: 
country: Saudi Arabia
responsible party type: Principal Investigator
investigator affiliation: King Saud University
investigator full name: AMIR IQBAL
investigator title: Principal Investigator
mesh term: Stroke
mesh term: Infarction, Middle Cerebral Artery
sharing ipd: Undecided
ipd description: Undecided