<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/NCT03788629</url>
  </required_header>
  <id_info>
    <org_study_id>2018500</org_study_id>
    <nct_id>NCT03788629</nct_id>
  </id_info>
  <brief_title>THE EFFECTS OF SUBTALAR JOINT MOBILIZATION ON PATIENTS WITH CHRONIC STROKE</brief_title>
  <official_title>THE EFFECTS OF SUBTALAR JOINT MOBILIZATION WITH MOVEMENT ON MUSCLE STRENGTH, BALANCE, FUNCTIONAL PERFORMANCE AND GAIT PARAMETERS IN PATIENTS WITH CHRONIC STROKE</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe 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>
      Adequate ankle motion for normal gait ranges from 10° to 15° of dorsiflexion passive range of&#xD;
      motion (DF-PROM) to allow the tibia to move over the talus. However, limited ankle mobility&#xD;
      is a common impairment in patients with stroke whose DF-PROM has been shown to be&#xD;
      approximately half of that in healthy subjects. As a result, these patients have impaired&#xD;
      dynamic balance in standing or gait. Mulligan first proposed mobilization with movement (MWM)&#xD;
      as a joint mobilization technique. Talocrural MWM to facilitate DF-ROM is performed by&#xD;
      applying a posteroanterior tibia glide over a fixed talus while the patient actively moves&#xD;
      into a dorsiflexed position while standing. Talocrural MWM has been applied to chronic ankle&#xD;
      instability and has been proven effective in improving DF-PROM and standing balance. Subtalar&#xD;
      MWM to facilitate DF-ROM is performed by bringing foot to dorsiflexion-abduction-eversion by&#xD;
      flexing patient' knee.&#xD;
&#xD;
      The effects of subtalar MWM have not been investigated in patients with stroke. Therefore,&#xD;
      the purpose of the present study is to examine the effects of subtalar MWM on muscle&#xD;
      strength, balance, functional performance, and gait parameters in patients with chronic&#xD;
      stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Neural factors, such as spasticity, or an increase in the sensitivity of the myotatic reflex,&#xD;
      can contribute significantly to calf muscle stiffness. Likewise, non-neural factors, such as&#xD;
      immobilization and age-induced changes in the mechanical properties of muscle and connective&#xD;
      tissue, are known to increase resistance to joint movement and to contribute to the limited&#xD;
      DF-PROM. Both neural and non-neural factors can impair ankle motion, resulting in balance&#xD;
      impairments during standing or gait. Limited DF-PROM can alter foot positioning in weight&#xD;
      bearing, resulting in hyperextension of the knee, and decreased ability to shift the center&#xD;
      of gravity (COG) during standing and gait. A variety of interventions, such as stretching and&#xD;
      joint mobilization, have been attempted to attenuate the effects of limited DF-PROM and to&#xD;
      reduce further deterioration in patients post stroke. Both stretching and joint mobilization&#xD;
      have been proven effective for improving ankle passive range of motion in patients with&#xD;
      stroke; however, there is a limit to the durability of the effect and improvements in&#xD;
      functional ability. For this reason, improvements in joint range of motion (ROM) must be&#xD;
      accompanied by gains in muscle strength to improve functional ability. This is especially&#xD;
      true for patients with hemiplegia who are not capable of weight bearing symmetrically and&#xD;
      require additional training, including repetitive and continuous weight bearing on the&#xD;
      paretic lower limb.&#xD;
&#xD;
      Adequate ankle motion for normal gait ranges from 10° to 15° of dorsiflexion passive range of&#xD;
      motion (DF-PROM) to allow the tibia to move over the talus. However, limited ankle mobility&#xD;
      is a common impairment in patients with stroke whose DF-PROM has been shown to be&#xD;
      approximately half of that in healthy subjects. As a result, these patients have impaired&#xD;
      dynamic balance in standing or gait. Mulligan first proposed mobilization with movement (MWM)&#xD;
      as a joint mobilization technique. Talocrural MWM to facilitate DF-ROM is performed by&#xD;
      applying a posteroanterior tibia glide over a fixed talus while the patient actively moves&#xD;
      into a dorsiflexed position while standing. Talocrural MWM has been applied to chronic ankle&#xD;
      instability and has been proven effective in improving DF-PROM and standing balance. Subtalar&#xD;
      MWM to facilitate DF-ROM is performed by bringing foot to dorsiflexion-abduction-eversion by&#xD;
      flexing patient' knee.&#xD;
&#xD;
      The effects of subtalar MWM have not been investigated in patients with stroke. Therefore,the&#xD;
      purpose of the present study is to examine the effects of subtalar MWM on muscle strength,&#xD;
      balance, functional performance, and gait parameters in patients with chronic stroke.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2018</start_date>
  <completion_date type="Actual">September 20, 2018</completion_date>
  <primary_completion_date type="Actual">August 20, 2018</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>Randomized</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Care Provider)</masking>
    <masking_description>Single blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Isokinetic Strength Dynamometer</measure>
    <time_frame>6 weeks</time_frame>
    <description>Maximal concentric contraction was measured for the dorsiflexors and plantarflexors using an isokinetic dynamometer (Biodex System Pro 4 Isokinetic Strength Dynamomter , Inc., Shirley, NY). The participants were seated with the ankle joint axis aligned.with the mechanical axis of the dynamometer. A performed practice trial to familiarize themselves with the test protocol, the participants were instructed to push and pull the attachment as hard and as fast as possible. Five maximum concentric contractions were performed at 30°/s and the peak torque generated over 5 repetitions was recorded and normalized to body weight (Nm/kg).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Timed up and Go Test</measure>
    <time_frame>6 weeks</time_frame>
    <description>To determine fall risk and measure the progress of balance, sit to stand and walking.The patient starts in a seated position.The patient stands up upon therapist's command: walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated. The subject is allowed to use an assistive device. Be sure to document the assistive device used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Berg Balance Scale</measure>
    <time_frame>6 weeks</time_frame>
    <description>The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biodex Gait Trainer Treadmill System (BGTTS)</measure>
    <time_frame>6 weeks</time_frame>
    <description>The BGTTS system is designed specifically for rehabilitation and retraining of gait for patients with neurologic and orthopaedic gait dysfunctions. The treadmill permits walking to be initiated from 0.0 km/h and increased by increments of 0.16 km/h. The patient can also hold onto a horizontal bar attached to the front of the treadmill for stability. The bodyweight support system includes an overhead harness with a pelvic band that attaches around the hips and 2 thigh straps with anterior and posterior attachments to the pelvic band. The harness vertically supports the patient over the treadmill and is attached to a suspension system with a force transducer that signals the amount of body weight supported.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Hemiplegia, Spastic</condition>
  <arm_group>
    <arm_group_label>Study Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bobath Concept+ Talocrural joint Mulligan MWM techniques were applied to this group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study Group 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subtalar joint Mulligan MWM techniques were applied to this group in addition to Bobath Concept+ Talocrural joint Mulligan MWM techniques</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Talocrural joint MWM mobilization</intervention_name>
    <description>There were two groups for this study. In addition to Bobath Concept, talocrural joint mobilization was performed.</description>
    <arm_group_label>Study Group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Subtalar joint MWM mobilization</intervention_name>
    <description>There were two groups for this study. In addition to treatment of control group, subtalar joint mobilization was performed.</description>
    <arm_group_label>Study Group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  hemiplegic stroke (&gt;6 months post stroke),&#xD;
&#xD;
          -  ability to perform a single-leg lunge on the paretic lower limb onto a stool from a&#xD;
             standing position,&#xD;
&#xD;
          -  ability to walk without an assistive device for more than 10 m,&#xD;
&#xD;
          -  limited dorsiflexion passive ROM with contracture of the paretic ankle, and capability&#xD;
             of following simple verbal instructions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  visual impairment,&#xD;
&#xD;
          -  unilateral neglect,&#xD;
&#xD;
          -  aphasia.&#xD;
&#xD;
          -  contraindications for joint mobilization (i.e., ankle joint hypermobility, trauma, or&#xD;
             inflammation),&#xD;
&#xD;
          -  ankle sprain in the previous 6 weeks,&#xD;
&#xD;
          -  any history of ankle surgery,&#xD;
&#xD;
          -  and those concurrently receiving similar interventions outside of the present study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Caner KARARTI</name>
      <address>
        <city>Kırşehir</city>
        <zip>40100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>December 25, 2018</study_first_submitted>
  <study_first_submitted_qc>December 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>April 5, 2020</last_update_submitted>
  <last_update_submitted_qc>April 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>Caner Karartı</investigator_full_name>
    <investigator_title>Caner Karartı, Hacettepe University</investigator_title>
  </responsible_party>
  <keyword>hemiplegia</keyword>
  <keyword>foot</keyword>
  <keyword>mobilization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemiplegia</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/NCT03788629
org study id: 2018500
nct id: NCT03788629
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Adequate ankle motion for normal gait ranges from 10° to 15° of dorsiflexion passive range of
      motion (DF-PROM) to allow the tibia to move over the talus. However, limited ankle mobility
      is a common impairment in patients with stroke whose DF-PROM has been shown to be
      approximately half of that in healthy subjects. As a result, these patients have impaired
      dynamic balance in standing or gait. Mulligan first proposed mobilization with movement (MWM)
      as a joint mobilization technique. Talocrural MWM to facilitate DF-ROM is performed by
      applying a posteroanterior tibia glide over a fixed talus while the patient actively moves
      into a dorsiflexed position while standing. Talocrural MWM has been applied to chronic ankle
      instability and has been proven effective in improving DF-PROM and standing balance. Subtalar
      MWM to facilitate DF-ROM is performed by bringing foot to dorsiflexion-abduction-eversion by
      flexing patient' knee.

      The effects of subtalar MWM have not been investigated in patients with stroke. Therefore,
      the purpose of the present study is to examine the effects of subtalar MWM on muscle
      strength, balance, functional performance, and gait parameters in patients with chronic
      stroke.
Neural factors, such as spasticity, or an increase in the sensitivity of the myotatic reflex,
      can contribute significantly to calf muscle stiffness. Likewise, non-neural factors, such as
      immobilization and age-induced changes in the mechanical properties of muscle and connective
      tissue, are known to increase resistance to joint movement and to contribute to the limited
      DF-PROM. Both neural and non-neural factors can impair ankle motion, resulting in balance
      impairments during standing or gait. Limited DF-PROM can alter foot positioning in weight
      bearing, resulting in hyperextension of the knee, and decreased ability to shift the center
      of gravity (COG) during standing and gait. A variety of interventions, such as stretching and
      joint mobilization, have been attempted to attenuate the effects of limited DF-PROM and to
      reduce further deterioration in patients post stroke. Both stretching and joint mobilization
      have been proven effective for improving ankle passive range of motion in patients with
      stroke; however, there is a limit to the durability of the effect and improvements in
      functional ability. For this reason, improvements in joint range of motion (ROM) must be
      accompanied by gains in muscle strength to improve functional ability. This is especially
      true for patients with hemiplegia who are not capable of weight bearing symmetrically and
      require additional training, including repetitive and continuous weight bearing on the
      paretic lower limb.

      Adequate ankle motion for normal gait ranges from 10° to 15° of dorsiflexion passive range of
      motion (DF-PROM) to allow the tibia to move over the talus. However, limited ankle mobility
      is a common impairment in patients with stroke whose DF-PROM has been shown to be
      approximately half of that in healthy subjects. As a result, these patients have impaired
      dynamic balance in standing or gait. Mulligan first proposed mobilization with movement (MWM)
      as a joint mobilization technique. Talocrural MWM to facilitate DF-ROM is performed by
      applying a posteroanterior tibia glide over a fixed talus while the patient actively moves
      into a dorsiflexed position while standing. Talocrural MWM has been applied to chronic ankle
      instability and has been proven effective in improving DF-PROM and standing balance. Subtalar
      MWM to facilitate DF-ROM is performed by bringing foot to dorsiflexion-abduction-eversion by
      flexing patient' knee.

      The effects of subtalar MWM have not been investigated in patients with stroke. Therefore,the
      purpose of the present study is to examine the effects of subtalar MWM on muscle strength,
      balance, functional performance, and gait parameters in patients with chronic stroke.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized
primary purpose: Treatment
masking: Single (Care Provider)
masking description: Single blinded
measure: Isokinetic Strength Dynamometer
time frame: 6 weeks
description: Maximal concentric contraction was measured for the dorsiflexors and plantarflexors using an isokinetic dynamometer (Biodex System Pro 4 Isokinetic Strength Dynamomter , Inc., Shirley, NY). The participants were seated with the ankle joint axis aligned.with the mechanical axis of the dynamometer. A performed practice trial to familiarize themselves with the test protocol, the participants were instructed to push and pull the attachment as hard and as fast as possible. Five maximum concentric contractions were performed at 30°/s and the peak torque generated over 5 repetitions was recorded and normalized to body weight (Nm/kg).
measure: Timed up and Go Test
time frame: 6 weeks
description: To determine fall risk and measure the progress of balance, sit to stand and walking.The patient starts in a seated position.The patient stands up upon therapist's command: walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated. The subject is allowed to use an assistive device. Be sure to document the assistive device used.
measure: Berg Balance Scale
time frame: 6 weeks
description: The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.
measure: Biodex Gait Trainer Treadmill System (BGTTS)
time frame: 6 weeks
description: The BGTTS system is designed specifically for rehabilitation and retraining of gait for patients with neurologic and orthopaedic gait dysfunctions. The treadmill permits walking to be initiated from 0.0 km/h and increased by increments of 0.16 km/h. The patient can also hold onto a horizontal bar attached to the front of the treadmill for stability. The bodyweight support system includes an overhead harness with a pelvic band that attaches around the hips and 2 thigh straps with anterior and posterior attachments to the pelvic band. The harness vertically supports the patient over the treadmill and is attached to a suspension system with a force transducer that signals the amount of body weight supported.
arm group label: Study Group 1
arm group type: Experimental
description: Bobath Concept+ Talocrural joint Mulligan MWM techniques were applied to this group.
arm group label: Study Group 2
arm group type: Active Comparator
description: Subtalar joint Mulligan MWM techniques were applied to this group in addition to Bobath Concept+ Talocrural joint Mulligan MWM techniques
intervention type: Other
intervention name: Talocrural joint MWM mobilization
description: There were two groups for this study. In addition to Bobath Concept, talocrural joint mobilization was performed.
arm group label: Study Group 1
intervention type: Other
intervention name: Subtalar joint MWM mobilization
description: There were two groups for this study. In addition to treatment of control group, subtalar joint mobilization was performed.
arm group label: Study Group 2
criteria: 
gender: All
minimum age: 40 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: Caner Karartı
investigator title: Caner Karartı, Hacettepe University
mesh term: Hemiplegia