<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/NCT02250040</url>
  </required_header>
  <id_info>
    <org_study_id>2011/0417</org_study_id>
    <nct_id>NCT02250040</nct_id>
  </id_info>
  <brief_title>Effect of a Physiotherapy Protocol for Gait and Functional Recovery After Stroke</brief_title>
  <official_title>Development and Assessment of a New Physiotherapy Protocol for Gait Recovery After Stroke Based on Clinical and Functional Criteria</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Valencia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Universitario La Fe</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Valencia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to identify and evaluate the effect of a new protocol of&#xD;
      physiotherapy to retrain walking ability after stroke in subjects older than fifty-five. This&#xD;
      protocol was composed of specific, clearly defined and reproducible techniques, based on&#xD;
      clinical and functional criteria.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stroke is a major cause of morbidity and mortality in adults and the leading cause of&#xD;
      disability in all developed countries. Its incidence is approximately one million per year in&#xD;
      the European Union.&#xD;
&#xD;
      It produces a huge social impact, not only because of mortality but also by the high demand&#xD;
      for health and social services that involve its disabling effects on more than thirty&#xD;
      thousand Spanish every year. Hemiplegia is the most common physical consequence of stroke and&#xD;
      it is defined as the complete paralysis of the upper and lower extremities of one body side.&#xD;
      However, other consequences as perceptual, cognitive, sensory and communication problems&#xD;
      should be considered in the physiotherapy treatment.&#xD;
&#xD;
      Age is the most important risk indicator of stroke as it represents an exponential increase&#xD;
      in incidence. After the age of 55 the risk doubles for every decade and triples at 80. After&#xD;
      rehabilitation, most people who have suffered a stroke get to walk independently or with some&#xD;
      technical help, but approximately 50-60% continue to have a certain degree of motor&#xD;
      impairment and approximately 50% are, at least in part, dependent for daily life activities.&#xD;
      Therefore, gait recovery is one of the main objectives in the rehabilitation process of&#xD;
      stroke survivors.&#xD;
&#xD;
      Regarding the process of rehabilitation after stroke, currently, there is insufficient&#xD;
      evidence to conclude that any of the physical therapy approaches is more effective to promote&#xD;
      recovery of lower limb function or postural control than any other. Thus, future research&#xD;
      should focus on determining the effectiveness of individual techniques clearly described and&#xD;
      specific treatments for each problem regardless of their approach. Furthermore, after&#xD;
      reviewing the different approaches of physiotherapy rehabilitation after stroke, no&#xD;
      physiotherapy treatment protocols based on clinical status of the patient have been found.&#xD;
      Instead, vague and general instructions are given, so it is necessary to clarify what to do,&#xD;
      when and what is the effectiveness of these techniques.&#xD;
&#xD;
      On the other hand, studies have scarcely taken into account the special characteristics of&#xD;
      the elderly as a population group so involved in this pathology.&#xD;
&#xD;
      This study aims at addressing these issues, since its main objective is to identify and&#xD;
      evaluate the effect of a protocol of physiotherapy to retrain walking ability after stroke in&#xD;
      patients older than fifty-five, composed of specific, clearly defined and reproducible&#xD;
      techniques, based on clinical and functional criteria.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2011</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</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>Barthel Index</measure>
    <time_frame>up to 6 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional physiotherapy for stroke.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Target group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Techniques based on patients' functional level were added.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional physiotherapy</intervention_name>
    <description>Physiotherapy techniques that included muscle training, stretching and endurance.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Target group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Techniques based on patients' functional level were added.</intervention_name>
    <description>The added techniques aimed to improve balance and movement dissociation.</description>
    <arm_group_label>Target group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Having suffered a single stroke episode with residual hemiparesis&#xD;
&#xD;
          -  Being candidate to begin a rehabilitation programme&#xD;
&#xD;
          -  Being able to walk before suffering the stroke&#xD;
&#xD;
          -  Having the ability to understand and follow simple instructions&#xD;
&#xD;
          -  Being hemodynamically stable within the first week after stroke&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Poor vital prognosis&#xD;
&#xD;
          -  Pathologies or disorders hampering the development of the study such as: blindness,&#xD;
             prosthetics, sensory disorders, severe cognitive impairment and so on&#xD;
&#xD;
          -  Absence of motor impairments after stroke&#xD;
&#xD;
          -  Pre-stroke disorders that affected the ability to walk&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Enrique Viosca-Herrero, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Universitario La Fe</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Juan-Manuel Belda-Lois, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Instituto de Biomecanica de Valencia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Celedonia Igual-Camacho, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Valencia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital La Fe</name>
      <address>
        <city>Valencia</city>
        <zip>46009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>April 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>September 25, 2014</last_update_submitted>
  <last_update_submitted_qc>September 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Valencia</investigator_affiliation>
    <investigator_full_name>M Luz Sanchez</investigator_full_name>
    <investigator_title>DPT</investigator_title>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Physiotherapy</keyword>
  <keyword>Functional Recovery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT02250040
org study id: 2011/0417
nct id: NCT02250040
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study was to identify and evaluate the effect of a new protocol of
      physiotherapy to retrain walking ability after stroke in subjects older than fifty-five. This
      protocol was composed of specific, clearly defined and reproducible techniques, based on
      clinical and functional criteria.
Stroke is a major cause of morbidity and mortality in adults and the leading cause of
      disability in all developed countries. Its incidence is approximately one million per year in
      the European Union.

      It produces a huge social impact, not only because of mortality but also by the high demand
      for health and social services that involve its disabling effects on more than thirty
      thousand Spanish every year. Hemiplegia is the most common physical consequence of stroke and
      it is defined as the complete paralysis of the upper and lower extremities of one body side.
      However, other consequences as perceptual, cognitive, sensory and communication problems
      should be considered in the physiotherapy treatment.

      Age is the most important risk indicator of stroke as it represents an exponential increase
      in incidence. After the age of 55 the risk doubles for every decade and triples at 80. After
      rehabilitation, most people who have suffered a stroke get to walk independently or with some
      technical help, but approximately 50-60% continue to have a certain degree of motor
      impairment and approximately 50% are, at least in part, dependent for daily life activities.
      Therefore, gait recovery is one of the main objectives in the rehabilitation process of
      stroke survivors.

      Regarding the process of rehabilitation after stroke, currently, there is insufficient
      evidence to conclude that any of the physical therapy approaches is more effective to promote
      recovery of lower limb function or postural control than any other. Thus, future research
      should focus on determining the effectiveness of individual techniques clearly described and
      specific treatments for each problem regardless of their approach. Furthermore, after
      reviewing the different approaches of physiotherapy rehabilitation after stroke, no
      physiotherapy treatment protocols based on clinical status of the patient have been found.
      Instead, vague and general instructions are given, so it is necessary to clarify what to do,
      when and what is the effectiveness of these techniques.

      On the other hand, studies have scarcely taken into account the special characteristics of
      the elderly as a population group so involved in this pathology.

      This study aims at addressing these issues, since its main objective is to identify and
      evaluate the effect of a protocol of physiotherapy to retrain walking ability after stroke in
      patients older than fifty-five, composed of specific, clearly defined and reproducible
      techniques, based on clinical and functional criteria.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Barthel Index
time frame: up to 6 months
arm group label: Control group
arm group type: Active Comparator
description: Conventional physiotherapy for stroke.
arm group label: Target group
arm group type: Experimental
description: Techniques based on patients' functional level were added.
intervention type: Other
intervention name: Conventional physiotherapy
description: Physiotherapy techniques that included muscle training, stretching and endurance.
arm group label: Control group
arm group label: Target group
intervention type: Other
intervention name: Techniques based on patients' functional level were added.
description: The added techniques aimed to improve balance and movement dissociation.
arm group label: Target group
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Enrique Viosca-Herrero, PhD
role: Study Director
affiliation: Hospital Universitario La Fe
last name: Juan-Manuel Belda-Lois, PhD
role: Study Director
affiliation: Instituto de Biomecanica de Valencia
last name: Celedonia Igual-Camacho, PhD
role: Study Director
affiliation: University of Valencia
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Valencia
investigator full name: M Luz Sanchez
investigator title: DPT
mesh term: Stroke