<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/NCT03024190</url>
  </required_header>
  <id_info>
    <org_study_id>CMRPG8F1101</org_study_id>
    <nct_id>NCT03024190</nct_id>
  </id_info>
  <brief_title>Kinesiotaping Combined With Therapeutic Exercise in Upper Extremity Spasticity and Function in Subacute Stroke Patients</brief_title>
  <official_title>The Clinical Effect and Sonographic Findings of Kinesiotaping Combined With Therapeutic Exercise in Upper Extremity Spasticity and Function in Subacute Stroke Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Poststroke spasticity (PSS) is one of the common complications in stroke patients who had a&#xD;
      brain injury leading to limbs weakness and impaired coordination between agonist and&#xD;
      antagonist contraction. PSS leads some physical impairments and functional deficits. The&#xD;
      clinical managements for PSS are stretching and range of motion (ROM) exercises,&#xD;
      antispasticity splint, neuromuscular electrical stimulation, oral medications, local&#xD;
      injection with phenol or botulism, or surgery. Recently, some investigators tried to use&#xD;
      Kinesiotaping (KT) for spasticity management or postural control. They found some benefits in&#xD;
      walking ability and upper extremity function facilitation after stroke.&#xD;
&#xD;
      40 subacute stroke patients with hemiplegia would be enrolled in this study. These 40&#xD;
      patients will be randomly divided into the experimental and control groups. In experimental&#xD;
      group (n=20), the patients will perform combined KT and 15- min stretching exercise for upper&#xD;
      extremity twice daily and regular rehabilitation program for 3 weeks. In the control group&#xD;
      (n=20), the patients will perform 15- min stretching exercise for upper extremity twice daily&#xD;
      and regular rehabilitation program for 3 weeks. Before intervention, immediately and 2 week&#xD;
      post intervention, all patients will receive associated physical examinations, hand function&#xD;
      evaluations, and sonography.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, 40 subacute stroke patients (duration is 3~6 months after stroke) with&#xD;
      hemiplegia would be enrolled. Each stroke patient is diagnosed by a neurologist according to&#xD;
      the history, physical examination, and brain imaging evaluation. These 40 patients would be&#xD;
      randomly divided into a experimental or a control group. All patients in the control and&#xD;
      experimental groups will both receive regular rehabilitation therapy including occupational&#xD;
      therapy (OT) 3 times per week and one hour for one session OT intervention. Additionally, 15-&#xD;
      min stretching exercise for upper extremity twice daily will be performed for 3 weeks in this&#xD;
      study. KT intervention in the experimental group: The technique of KT for spastic wrist and&#xD;
      fingers in stroke patient will be performed from the proximal interphalangeal joints of all&#xD;
      fingers acted on the extensor carpal and digital muscle groups, with an anchor at the&#xD;
      proximal one-third forearm. The KT will be applied for 5 days one week for 3 weeks.&#xD;
&#xD;
      In this study, all patients in the control and experimental groups will receive the following&#xD;
      evaluations before intervention, immediately post intervention, and 2-week after&#xD;
      intervention: Physical examinations (modified shworth scale and Tardieu scale), Hand function&#xD;
      evaluation (Fugl-Meyer Assessment for upper extremity, box and block test, and Minnesota&#xD;
      Manual Dexterity Test), and Musculoskeletal sonography (sonoelastography and shear wave&#xD;
      velocity). SPSS software will be used to record and analysis the collecting data.&#xD;
      Investigators will analyze and compare the findings of physical examinations, upper extremity&#xD;
      function assessments, and musculoskeletal sonography within and between the experimental and&#xD;
      control groups before and after interventions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">July 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fugl-Meyer assessment for upper extremity (FMA-UE) for hand function</measure>
    <time_frame>baseline (before intervention), changes from baseline FMA-UE scores at 3 weeks and 5 weeks.</time_frame>
    <description>A physical therapist will use Fugl-Meyer assessment for upper extremity (FMA-UE) to evaluate patient's hand function and analyze the changes on the score of it from baseline till third week and fifth week.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modified Ashworth scale for level of spasticity of affected arm</measure>
    <time_frame>baseline (before intervention), changes from baseline level of spasticity at 3 weeks and 5 weeks.</time_frame>
    <description>A physical therapist will measure the level of spasticity in affected arm by using modified Ashworth scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the change from baseline on hemiplegic upper extremity sonography</measure>
    <time_frame>baseline (before intervention), changes from baseline sonography results at 3 weeks and 5 weeks.</time_frame>
    <description>for the flexor carpal ulnaris (FCU), flexor carpal radialis (FCR), and flexor digitorum superficialis (FDS) muscles.&#xD;
The participants will sit upright and put their upper extremities on the bed with elbow flexion in 90 degree and the forearm full supination. The measured levels for evaluating FCR, FCU, and FDS muscles will be recorded at first time and use the same level after intervention for each patient. The SWV will be done in the transverse plane and be performed at the maximal cross-section area of the muscles and repeatedly measured for 7 times for each muscle. The sonoelastography will be applied in the longitudinal plane of the detected muscles at the same level of the SWV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brunnstrom motor recovery stage for motor ability</measure>
    <time_frame>baseline (before intervention), changes from baseline motor recovery stage at 3 weeks and 5 weeks.</time_frame>
    <description>A physical therapist will measure Brunnstrom motor recovery stage and see the improvement of it from baseline till third week and fifth week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Tardieu scale for level of spasticity of affected arm</measure>
    <time_frame>baseline (before intervention), changes from baseline level of spasticity at 3 weeks and 5 weeks.</time_frame>
    <description>A physical therapist will measure the level of spasticity in affected arm by using modified Tardieu scale.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Stroke</condition>
  <condition>Upper Extremity Spasticity</condition>
  <arm_group>
    <arm_group_label>with Kinesiotaping</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>stretching exercises combined with Kinesiotaping&#xD;
regular OT rehabilitation program for 3 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>the patients will receive 15-min stretching exercises&#xD;
regular OT rehabilitation program for 3 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Kinesiotaping</intervention_name>
    <description>The technique of Kinesiotaping for spastic wrists and fingers in stroke patients is performed from the proximal interphalangeal joints of all fingers acted on the extensor carpal and digital muscle groups, with an anchor at the proximal one-third forearm.</description>
    <arm_group_label>with Kinesiotaping</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>stretching exercise</intervention_name>
    <description>15- min stretching exercise for upper extremity twice daily</description>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>with Kinesiotaping</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>OT rehabilitation program</intervention_name>
    <description>regular rehabilitation program for 3 weeks</description>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>with Kinesiotaping</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  stroke with hemiplegia (duration is 3~6 months after stroke).&#xD;
&#xD;
          -  The upper extremity function of participated patients could perform hand grasp and&#xD;
             release movements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age is younger than 18 years or older than 80 years&#xD;
&#xD;
          -  previous history of upper extremity tendon or neuromuscular injury&#xD;
&#xD;
          -  any other systemic neuromuscular disease&#xD;
&#xD;
          -  cognition or language impairment leading to communication difficulty&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yu Chi Huang, Bachelor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
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  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>September 21, 2018</last_update_submitted>
  <last_update_submitted_qc>September 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>spasticity</keyword>
  <keyword>Kinesiotaping</keyword>
  <keyword>sonography</keyword>
  <keyword>exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Spasticity</mesh_term>
    <mesh_term>Stroke</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/NCT03024190
org study id: CMRPG8F1101
nct id: NCT03024190
lead sponsor: 
has dmc: No
Poststroke spasticity (PSS) is one of the common complications in stroke patients who had a
      brain injury leading to limbs weakness and impaired coordination between agonist and
      antagonist contraction. PSS leads some physical impairments and functional deficits. The
      clinical managements for PSS are stretching and range of motion (ROM) exercises,
      antispasticity splint, neuromuscular electrical stimulation, oral medications, local
      injection with phenol or botulism, or surgery. Recently, some investigators tried to use
      Kinesiotaping (KT) for spasticity management or postural control. They found some benefits in
      walking ability and upper extremity function facilitation after stroke.

      40 subacute stroke patients with hemiplegia would be enrolled in this study. These 40
      patients will be randomly divided into the experimental and control groups. In experimental
      group (n=20), the patients will perform combined KT and 15- min stretching exercise for upper
      extremity twice daily and regular rehabilitation program for 3 weeks. In the control group
      (n=20), the patients will perform 15- min stretching exercise for upper extremity twice daily
      and regular rehabilitation program for 3 weeks. Before intervention, immediately and 2 week
      post intervention, all patients will receive associated physical examinations, hand function
      evaluations, and sonography.
In this study, 40 subacute stroke patients (duration is 3~6 months after stroke) with
      hemiplegia would be enrolled. Each stroke patient is diagnosed by a neurologist according to
      the history, physical examination, and brain imaging evaluation. These 40 patients would be
      randomly divided into a experimental or a control group. All patients in the control and
      experimental groups will both receive regular rehabilitation therapy including occupational
      therapy (OT) 3 times per week and one hour for one session OT intervention. Additionally, 15-
      min stretching exercise for upper extremity twice daily will be performed for 3 weeks in this
      study. KT intervention in the experimental group: The technique of KT for spastic wrist and
      fingers in stroke patient will be performed from the proximal interphalangeal joints of all
      fingers acted on the extensor carpal and digital muscle groups, with an anchor at the
      proximal one-third forearm. The KT will be applied for 5 days one week for 3 weeks.

      In this study, all patients in the control and experimental groups will receive the following
      evaluations before intervention, immediately post intervention, and 2-week after
      intervention: Physical examinations (modified shworth scale and Tardieu scale), Hand function
      evaluation (Fugl-Meyer Assessment for upper extremity, box and block test, and Minnesota
      Manual Dexterity Test), and Musculoskeletal sonography (sonoelastography and shear wave
      velocity). SPSS software will be used to record and analysis the collecting data.
      Investigators will analyze and compare the findings of physical examinations, upper extremity
      function assessments, and musculoskeletal sonography within and between the experimental and
      control groups before and after interventions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Fugl-Meyer assessment for upper extremity (FMA-UE) for hand function
time frame: baseline (before intervention), changes from baseline FMA-UE scores at 3 weeks and 5 weeks.
description: A physical therapist will use Fugl-Meyer assessment for upper extremity (FMA-UE) to evaluate patient's hand function and analyze the changes on the score of it from baseline till third week and fifth week.
measure: Modified Ashworth scale for level of spasticity of affected arm
time frame: baseline (before intervention), changes from baseline level of spasticity at 3 weeks and 5 weeks.
description: A physical therapist will measure the level of spasticity in affected arm by using modified Ashworth scale.
measure: the change from baseline on hemiplegic upper extremity sonography
time frame: baseline (before intervention), changes from baseline sonography results at 3 weeks and 5 weeks.
description: for the flexor carpal ulnaris (FCU), flexor carpal radialis (FCR), and flexor digitorum superficialis (FDS) muscles.
The participants will sit upright and put their upper extremities on the bed with elbow flexion in 90 degree and the forearm full supination. The measured levels for evaluating FCR, FCU, and FDS muscles will be recorded at first time and use the same level after intervention for each patient. The SWV will be done in the transverse plane and be performed at the maximal cross-section area of the muscles and repeatedly measured for 7 times for each muscle. The sonoelastography will be applied in the longitudinal plane of the detected muscles at the same level of the SWV.
measure: Brunnstrom motor recovery stage for motor ability
time frame: baseline (before intervention), changes from baseline motor recovery stage at 3 weeks and 5 weeks.
description: A physical therapist will measure Brunnstrom motor recovery stage and see the improvement of it from baseline till third week and fifth week.
measure: Modified Tardieu scale for level of spasticity of affected arm
time frame: baseline (before intervention), changes from baseline level of spasticity at 3 weeks and 5 weeks.
description: A physical therapist will measure the level of spasticity in affected arm by using modified Tardieu scale.
arm group label: with Kinesiotaping
arm group type: Experimental
description: stretching exercises combined with Kinesiotaping
regular OT rehabilitation program for 3 weeks
arm group label: control group
arm group type: Other
description: the patients will receive 15-min stretching exercises
regular OT rehabilitation program for 3 weeks
intervention type: Other
intervention name: Kinesiotaping
description: The technique of Kinesiotaping for spastic wrists and fingers in stroke patients is performed from the proximal interphalangeal joints of all fingers acted on the extensor carpal and digital muscle groups, with an anchor at the proximal one-third forearm.
arm group label: with Kinesiotaping
intervention type: Other
intervention name: stretching exercise
description: 15- min stretching exercise for upper extremity twice daily
arm group label: control group
arm group label: with Kinesiotaping
intervention type: Other
intervention name: OT rehabilitation program
description: regular rehabilitation program for 3 weeks
arm group label: control group
arm group label: with Kinesiotaping
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yu Chi Huang, Bachelor
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
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responsible party type: Sponsor
mesh term: Muscle Spasticity
mesh term: Stroke
sharing ipd: Undecided
ipd description: undecided