<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/NCT04491162</url>
  </required_header>
  <id_info>
    <org_study_id>INK/ Rehab/ BWS/2016</org_study_id>
    <nct_id>NCT04491162</nct_id>
  </id_info>
  <brief_title>The Effect of Body Weight Support Treadmill Training on Lower Limb Function in Patients With Chronic Stroke</brief_title>
  <official_title>The Effect of Body Weight Support Treadmill Training on Lower Limb Function in Patients With Chronic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Mental Health and Neuro Sciences, India</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institute of Mental Health and Neuro Sciences, India</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>
      Stroke has severe debilitating neurological consequences for the victim. Within context of&#xD;
      this study, gait disturbance is induced by disabilities in muscle weakness, abnormal muscle&#xD;
      contraction, or postural control. Gait disturbance has an unfavorable effect on functional&#xD;
      independence and prognosis of patients. Due to this reason, recovery in gait ability of&#xD;
      stroke patients is considered as a very important goal in rehabilitation.&#xD;
&#xD;
      Body weight supported treadmill training (BWSTT) is a task-oriented technique for gait&#xD;
      restoration after stroke. The present study focused on the possibility of BWSTT as a special&#xD;
      program for improving gait ability. The purpose of this study was to evaluate the&#xD;
      effectiveness of a BWSTT intervention useful as a short-term intensive program for chronic&#xD;
      stroke survivors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stroke is thought to be a serious health problem which can cause severe disabilities. Aspects&#xD;
      of disabilities caused by stroke are various according to the affected region and its&#xD;
      severity. In general, sensory deficits, cognitive problem, motor impairment, visual&#xD;
      perceptual disorders and dysphagia mainly occur among stroke patients. In particular, gait&#xD;
      disturbance is induced by disabilities in muscle weakness, abnormal muscle contraction, or&#xD;
      postural control. This gait disturbance is exhibited as an asymmetric gait pattern, such as a&#xD;
      decrease in paretic side stance phase and non-paretic swing phase, cadence, velocity and&#xD;
      difference in step length and stride length. Therefore, these differences create abnormal&#xD;
      gait patterns in stroke patients. Furthermore, gait disturbance has an unfavorable effect on&#xD;
      functional independence and prognosis of patients. Due to this reason, recovery in gait&#xD;
      ability of stroke patients is considered as a very important goal in rehabilitation.&#xD;
&#xD;
      Gait performance is an indicator of mobility impairment and disability after stroke. It&#xD;
      predicts mortality, morbidity, and risk of future stroke. Gait speed is responsive to&#xD;
      short-term rehabilitation. An improvement in gait speed of 0.16 m/s can reduce the level of&#xD;
      assistance in patients with subacute stroke and was recommended to be the minimum clinically&#xD;
      significant difference. The control of gait involves the planning and execution from multiple&#xD;
      cortical areas, such as secondary and premotor cortex. Stroke patients often have gait&#xD;
      impairment such as decreased gait speed and asymmetrical gait cycle as a result of cortical&#xD;
      reorganization. Repetitive mass motor task practice had been shown to facilitate&#xD;
      neuroplasticity and brain reorganization in stroke patients, resulting in enhanced motor&#xD;
      recovery after stroke.&#xD;
&#xD;
      Body weight supported treadmill training (BWSTT) is a task-oriented technique for gait&#xD;
      restoration after stroke. BWSTT has the advantage over conventional therapy as it offers&#xD;
      higher intensity, more repetitive and task-oriented practice over the same period of time&#xD;
      when compared to conventional therapy. Several studies have showed that BWSTT was more&#xD;
      effective in gait speed improvement than regular physiotherapy. It has been demonstrated that&#xD;
      BWSTT induces changes in corticomotor excitability which lead to improved balance and gait&#xD;
      performance with chronic stroke. However, other studies have reported that BWSTT was not&#xD;
      superior to conventional gait training.&#xD;
&#xD;
      Recent studies have reported that BWSTT can increase walking endurance in the subacute stage&#xD;
      after stroke, but no improvement was reported in balance and 10 m gait speed. To date, there&#xD;
      are very few studies that have used gait analysis to show how the improvements in gait&#xD;
      parameters come about after BWSTT or conventional therapy. There is still a lack of basic&#xD;
      understanding of gait training on human locomotion.&#xD;
&#xD;
      Despite substantial recovery of independent ambulation by survivors following unilateral&#xD;
      stroke, persistent gait abnormalities are observed in a large percentage of these persons. In&#xD;
      these circumstances, a short-term intermittent and intensive rehabilitation program for&#xD;
      chronic stroke survivors is thought to be particularly efficient for shoring up their&#xD;
      independence, and the present study focused on the possibility of BWSTT as a special program&#xD;
      for improving gait ability. The purpose of this study was to evaluate the effectiveness of a&#xD;
      BWSTT intervention useful as a short-term intensive program for chronic stroke survivors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">March 1, 2019</completion_date>
  <primary_completion_date type="Actual">March 1, 2019</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 (Investigator)</masking>
    <masking_description>The observer was not allowed to know the treatment allocation. The patients were instructed not to discuss anything regarding his/ her treatment allocation with the examining investigator.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>10 meter walk test</measure>
    <time_frame>Two weeks</time_frame>
    <description>The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cadence</measure>
    <time_frame>Two weeks</time_frame>
    <description>Cadence is measured as number of steps per minute during a 10 metre walk.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed up and go test</measure>
    <time_frame>Two weeks</time_frame>
    <description>The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance.&#xD;
It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Berg Balance Scale</measure>
    <time_frame>Two weeks</time_frame>
    <description>It is a widely used clinical test for static and dynamic balance. It comprises of 14 balance related tasks. A score of less than 20 signifies wheelchair use; 20-40: walking with assistance; 40-56: Independent ambulator.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Stroke</condition>
  <condition>Gait Disorder, Sensorimotor</condition>
  <arm_group>
    <arm_group_label>Conventional gait therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional gait therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BWST training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Conventional gait therapy + Body weight support treadmill training</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Body weight support treadmill training + conventional therapy</intervention_name>
    <description>Conventional gait therapy was done based on the principles of the proprioceptive neuromuscular facilitation (PNF) and Motor Relearning program (MRP) concepts.&#xD;
Patients in intervention arm were additionally trained with a 40% body weight support and a comfortable walking speed on treadmill for twenty minutes. The training, which was conducted three times a week, for period of two weeks.</description>
    <arm_group_label>BWST training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional therapy</intervention_name>
    <description>Conventional gait therapy was done based on the principles of the proprioceptive neuromuscular facilitation (PNF) and Motor Relearning program (MRP) concepts.</description>
    <arm_group_label>Conventional gait therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Age between 18 and 69 years, both genders will be acceptable.&#xD;
&#xD;
          -  First episode of supratentorial stroke in hemiparesis (both ischaemic and haemorrhagic&#xD;
             strokes)&#xD;
&#xD;
          -  After 6 month from onset of stroke.&#xD;
&#xD;
          -  All subjects were ambulatory before stroke&#xD;
&#xD;
          -  Able to understand and follow simple verbal instruction, scoring at least 24 out of 30&#xD;
             on Mini Mental State Examination.&#xD;
&#xD;
          -  Able to walk at least 10 meters distance independently, with or without a walking&#xD;
             aids.&#xD;
&#xD;
          -  Walking speed&lt;0.75m/s at their self-selected velocity (SSV).&#xD;
&#xD;
          -  Scoring 3 or 4 in Functional Ambulation Category Scale.&#xD;
&#xD;
          -  Scoring less than 21 out of 23 on trunk Impairment Scale.&#xD;
&#xD;
          -  Currently not receiving any other type of physiotherapeutic intervention.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Neurological disease affecting balance other than stroke.&#xD;
&#xD;
          -  History of diagnosed musculoskeletal disorder of the trunk and / or lower extremities&#xD;
             affecting the motor performance.&#xD;
&#xD;
          -  History of Cerebrovascular accident more than one time or bilateral CVA at a time.&#xD;
&#xD;
          -  Myocardial infarction within the past 6 months.&#xD;
&#xD;
          -  Angina or ischemia at rest or during exercise.&#xD;
&#xD;
          -  Unstable hypertension (&gt;150/90 mmHg), arrhythmia, congestive heart failure or unstable&#xD;
             cardio vascular status.&#xD;
&#xD;
          -  Absence of active movement in the paretic lower limbs.&#xD;
&#xD;
          -  Disability of joint including hip fracture and severe cardio pulmonary disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Madhusree Sengupta, MD, PDF</last_name>
    <role>Principal Investigator</role>
    <affiliation>Consultant</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Neurosciences Kolkata</name>
      <address>
        <city>Kolkata</city>
        <state>West Bengal</state>
        <zip>700017</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Institute of Mental Health and Neuro Sciences, India</investigator_affiliation>
    <investigator_full_name>Dhritiman Chakrabarti</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Rehabilitation</keyword>
  <keyword>Body weight supported treadmill training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Gait Disorders, Neurologic</mesh_term>
    <mesh_term>Body Weight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04491162
org study id: INK/ Rehab/ BWS/2016
nct id: NCT04491162
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Stroke has severe debilitating neurological consequences for the victim. Within context of
      this study, gait disturbance is induced by disabilities in muscle weakness, abnormal muscle
      contraction, or postural control. Gait disturbance has an unfavorable effect on functional
      independence and prognosis of patients. Due to this reason, recovery in gait ability of
      stroke patients is considered as a very important goal in rehabilitation.

      Body weight supported treadmill training (BWSTT) is a task-oriented technique for gait
      restoration after stroke. The present study focused on the possibility of BWSTT as a special
      program for improving gait ability. The purpose of this study was to evaluate the
      effectiveness of a BWSTT intervention useful as a short-term intensive program for chronic
      stroke survivors.
Stroke is thought to be a serious health problem which can cause severe disabilities. Aspects
      of disabilities caused by stroke are various according to the affected region and its
      severity. In general, sensory deficits, cognitive problem, motor impairment, visual
      perceptual disorders and dysphagia mainly occur among stroke patients. In particular, gait
      disturbance is induced by disabilities in muscle weakness, abnormal muscle contraction, or
      postural control. This gait disturbance is exhibited as an asymmetric gait pattern, such as a
      decrease in paretic side stance phase and non-paretic swing phase, cadence, velocity and
      difference in step length and stride length. Therefore, these differences create abnormal
      gait patterns in stroke patients. Furthermore, gait disturbance has an unfavorable effect on
      functional independence and prognosis of patients. Due to this reason, recovery in gait
      ability of stroke patients is considered as a very important goal in rehabilitation.

      Gait performance is an indicator of mobility impairment and disability after stroke. It
      predicts mortality, morbidity, and risk of future stroke. Gait speed is responsive to
      short-term rehabilitation. An improvement in gait speed of 0.16 m/s can reduce the level of
      assistance in patients with subacute stroke and was recommended to be the minimum clinically
      significant difference. The control of gait involves the planning and execution from multiple
      cortical areas, such as secondary and premotor cortex. Stroke patients often have gait
      impairment such as decreased gait speed and asymmetrical gait cycle as a result of cortical
      reorganization. Repetitive mass motor task practice had been shown to facilitate
      neuroplasticity and brain reorganization in stroke patients, resulting in enhanced motor
      recovery after stroke.

      Body weight supported treadmill training (BWSTT) is a task-oriented technique for gait
      restoration after stroke. BWSTT has the advantage over conventional therapy as it offers
      higher intensity, more repetitive and task-oriented practice over the same period of time
      when compared to conventional therapy. Several studies have showed that BWSTT was more
      effective in gait speed improvement than regular physiotherapy. It has been demonstrated that
      BWSTT induces changes in corticomotor excitability which lead to improved balance and gait
      performance with chronic stroke. However, other studies have reported that BWSTT was not
      superior to conventional gait training.

      Recent studies have reported that BWSTT can increase walking endurance in the subacute stage
      after stroke, but no improvement was reported in balance and 10 m gait speed. To date, there
      are very few studies that have used gait analysis to show how the improvements in gait
      parameters come about after BWSTT or conventional therapy. There is still a lack of basic
      understanding of gait training on human locomotion.

      Despite substantial recovery of independent ambulation by survivors following unilateral
      stroke, persistent gait abnormalities are observed in a large percentage of these persons. In
      these circumstances, a short-term intermittent and intensive rehabilitation program for
      chronic stroke survivors is thought to be particularly efficient for shoring up their
      independence, and the present study focused on the possibility of BWSTT as a special program
      for improving gait ability. The purpose of this study was to evaluate the effectiveness of a
      BWSTT intervention useful as a short-term intensive program for chronic stroke survivors.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
masking description: The observer was not allowed to know the treatment allocation. The patients were instructed not to discuss anything regarding his/ her treatment allocation with the examining investigator.
measure: 10 meter walk test
time frame: Two weeks
description: The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.
measure: Cadence
time frame: Two weeks
description: Cadence is measured as number of steps per minute during a 10 metre walk.
measure: Timed up and go test
time frame: Two weeks
description: The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance.
It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
measure: Berg Balance Scale
time frame: Two weeks
description: It is a widely used clinical test for static and dynamic balance. It comprises of 14 balance related tasks. A score of less than 20 signifies wheelchair use; 20-40: walking with assistance; 40-56: Independent ambulator.
arm group label: Conventional gait therapy
arm group type: Active Comparator
description: Conventional gait therapy.
arm group label: BWST training
arm group type: Experimental
description: Conventional gait therapy + Body weight support treadmill training
intervention type: Other
intervention name: Body weight support treadmill training + conventional therapy
description: Conventional gait therapy was done based on the principles of the proprioceptive neuromuscular facilitation (PNF) and Motor Relearning program (MRP) concepts.
Patients in intervention arm were additionally trained with a 40% body weight support and a comfortable walking speed on treadmill for twenty minutes. The training, which was conducted three times a week, for period of two weeks.
arm group label: BWST training
intervention type: Other
intervention name: Conventional therapy
description: Conventional gait therapy was done based on the principles of the proprioceptive neuromuscular facilitation (PNF) and Motor Relearning program (MRP) concepts.
arm group label: Conventional gait therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 69 Years
healthy volunteers: No
last name: Madhusree Sengupta, MD, PDF
role: Principal Investigator
affiliation: Consultant
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: National Institute of Mental Health and Neuro Sciences, India
investigator full name: Dhritiman Chakrabarti
investigator title: Assistant Professor
mesh term: Stroke
mesh term: Gait Disorders, Neurologic
mesh term: Body Weight
sharing ipd: No