<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/NCT02999971</url>
  </required_header>
  <id_info>
    <org_study_id>UCoruna</org_study_id>
    <nct_id>NCT02999971</nct_id>
  </id_info>
  <brief_title>Effects of an Aquatic Therapy Program Versus a Land Program in Patients Who Suffered a Stroke</brief_title>
  <official_title>Effects of an Aquatic Circuit Class Therapy Program Versus a Land Circuit Class Therapy Program in Patients Who Suffered a Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade da Coruña</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade da Coruña</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>
      The objective of this study is to investigate the relative effectiveness of CCT on water&#xD;
      versus on land in stroke patients. Additionally, the study will to determine if there are&#xD;
      differences in the results obtained, between two CCT programs in the following parameters:&#xD;
      gait, balance and dexterity&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomized controlled trial of the effectiveness of a structured CCT program&#xD;
      in water versus a structured CCT program on land in the rehabilitation of stroke survivors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">June 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>10 meters walk test</measure>
    <time_frame>60 seconds</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Test Up &amp; Go</measure>
    <time_frame>5 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Berg Balance Scale (BBS)</measure>
    <time_frame>20 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Romberg Test</measure>
    <time_frame>1 minute</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fugl-Meyer Assessment</measure>
    <time_frame>15 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Reach Test (FRT)</measure>
    <time_frame>10 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Box and block test</measure>
    <time_frame>5 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy Scale</measure>
    <time_frame>5 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activities-Specific Balance Confidence Scale (ABC)</measure>
    <time_frame>10 minutes</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Stroke</condition>
  <condition>Hydrotherapy</condition>
  <arm_group>
    <arm_group_label>circuit class therapy in water</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CCT on water. The intervention developed in this study will be through the realization of an exercise program in circuit (CCT). One of the groups will receive treatment in the water (intervention group), and the other on land (control group). In both groups, the intervention will be a 7-week class therapy, 3-times weekly, giving a total of 20 sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>circuit class therapy on land</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CCT on land. The intervention developed in this study will be through the realization of an exercise program in circuit (CCT). One of the groups will receive treatment in the water (intervention group), and the other on land (control group). In both groups, the intervention will be a 7-week class therapy, 3-times weekly, giving a total of 20 sessions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>circuit class therapy in water</intervention_name>
    <description>The circuit, the main part of the session, include a series of 10 different workstations, arranged to progress in complexity, in order to work several segments of the body, oriented towards a functional recovery objective. These stations will be made up of task-specific activities for gait, balance and dexterity. Time in each workstation will be 5 minutes divided as follows: 4 minutes work period and 1 minute rest period, of these, last 30 seconds will be change period for crossing from one workstation to the next. After 50 minutes, each patient will have covered the 10 workstations, thus working in all of the objectives pursued in the realization on this CCT: gait, balance and dexterity.</description>
    <arm_group_label>circuit class therapy in water</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>circuit class therapy on land</intervention_name>
    <description>The circuit, the main part of the session, include a series of 10 different workstations, arranged to progress in complexity, in order to work several segments of the body, oriented towards a functional recovery objective. These stations will be made up of task-specific activities for gait, balance and dexterity. Time in each workstation will be 5 minutes divided as follows: 4 minutes work period and 1 minute rest period, of these, last 30 seconds will be change period for crossing from one workstation to the next. After 50 minutes, each patient will have covered the 10 workstations, thus working in all of the objectives pursued in the realization on this CCT: gait, balance and dexterity.</description>
    <arm_group_label>circuit class therapy on land</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with diagnosis of stroke (ischemic or hemorrhagic) onset ≤ 3 years; with&#xD;
             hemiparesis secondary;&#xD;
&#xD;
          -  age ≥18 to ≤ 90;&#xD;
&#xD;
          -  provide a written informed consent;&#xD;
&#xD;
          -  able to walk for at least 10 m without assistance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with uncontrolled or risky conditions (acute myocardial infarction,&#xD;
             arrhythmia, heart failure, uncontrolled hypertension or unstable cardiovascular&#xD;
             state);&#xD;
&#xD;
          -  with infectious diseases, ulcers or urinary and / or faecal incontinence;&#xD;
&#xD;
          -  additional neurological and / or orthopedic deficits that alter ambulation;&#xD;
&#xD;
          -  unable to follow treatment (cognitive, visual ...).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 18, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>March 30, 2020</last_update_submitted>
  <last_update_submitted_qc>March 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade da Coruña</investigator_affiliation>
    <investigator_full_name>IRENE PEGITO PEREZ</investigator_full_name>
    <investigator_title>Physiotherapy degree</investigator_title>
  </responsible_party>
  <keyword>circuit class therapy</keyword>
  <keyword>ICF model</keyword>
  <keyword>aquatic therapy</keyword>
  <keyword>neuro-rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT02999971
org study id: UCoruna
nct id: NCT02999971
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to investigate the relative effectiveness of CCT on water
      versus on land in stroke patients. Additionally, the study will to determine if there are
      differences in the results obtained, between two CCT programs in the following parameters:
      gait, balance and dexterity
This study is a randomized controlled trial of the effectiveness of a structured CCT program
      in water versus a structured CCT program on land in the rehabilitation of stroke survivors.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: 10 meters walk test
time frame: 60 seconds
measure: Test Up & Go
time frame: 5 minutes
measure: Berg Balance Scale (BBS)
time frame: 20 minutes
measure: Romberg Test
time frame: 1 minute
measure: Fugl-Meyer Assessment
time frame: 15 minutes
measure: Functional Reach Test (FRT)
time frame: 10 minutes
measure: Box and block test
time frame: 5 minutes
measure: Self-efficacy Scale
time frame: 5 minutes
measure: Activities-Specific Balance Confidence Scale (ABC)
time frame: 10 minutes
arm group label: circuit class therapy in water
arm group type: Experimental
description: CCT on water. The intervention developed in this study will be through the realization of an exercise program in circuit (CCT). One of the groups will receive treatment in the water (intervention group), and the other on land (control group). In both groups, the intervention will be a 7-week class therapy, 3-times weekly, giving a total of 20 sessions.
arm group label: circuit class therapy on land
arm group type: Experimental
description: CCT on land. The intervention developed in this study will be through the realization of an exercise program in circuit (CCT). One of the groups will receive treatment in the water (intervention group), and the other on land (control group). In both groups, the intervention will be a 7-week class therapy, 3-times weekly, giving a total of 20 sessions.
intervention type: Other
intervention name: circuit class therapy in water
description: The circuit, the main part of the session, include a series of 10 different workstations, arranged to progress in complexity, in order to work several segments of the body, oriented towards a functional recovery objective. These stations will be made up of task-specific activities for gait, balance and dexterity. Time in each workstation will be 5 minutes divided as follows: 4 minutes work period and 1 minute rest period, of these, last 30 seconds will be change period for crossing from one workstation to the next. After 50 minutes, each patient will have covered the 10 workstations, thus working in all of the objectives pursued in the realization on this CCT: gait, balance and dexterity.
arm group label: circuit class therapy in water
intervention type: Other
intervention name: circuit class therapy on land
description: The circuit, the main part of the session, include a series of 10 different workstations, arranged to progress in complexity, in order to work several segments of the body, oriented towards a functional recovery objective. These stations will be made up of task-specific activities for gait, balance and dexterity. Time in each workstation will be 5 minutes divided as follows: 4 minutes work period and 1 minute rest period, of these, last 30 seconds will be change period for crossing from one workstation to the next. After 50 minutes, each patient will have covered the 10 workstations, thus working in all of the objectives pursued in the realization on this CCT: gait, balance and dexterity.
arm group label: circuit class therapy on land
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Universidade da Coruña
investigator full name: IRENE PEGITO PEREZ
investigator title: Physiotherapy degree
mesh term: Stroke
sharing ipd: No