<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/NCT02237222</url>
  </required_header>
  <id_info>
    <org_study_id>GaitPerformance_2014</org_study_id>
    <nct_id>NCT02237222</nct_id>
  </id_info>
  <brief_title>Evaluation of Gait Performance in Children With Neuromuscular Diagnoses</brief_title>
  <official_title>Evaluation of the Gait Performance Measures 'Functional Mobility Scale' and 'Gillette Functional Assessment Questionnaire' in Children With Neuromuscular Diagnoses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Children's Hospital, Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Children's Hospital, Zurich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aims of this project are to evaluate the psychometric properties of the German versions&#xD;
      of the two performance questionnaires 'Functional Mobility Scale' (FMS) and 'Gillette&#xD;
      Functional Assessment Questionnaire - walking scale' (GFAQ) in children between 6-18 years&#xD;
      with a neuromuscular diagnosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The German versions of the two questionnaires 'Functional Mobility Scale' (FMS) and 'Gillette&#xD;
      Functional Assessment Questionnaire - walking scale' (GFAQ) are evaluated in terms of&#xD;
      construct validity, inter- and intra-rater reliability as well as responsiveness in children&#xD;
      with a neuromuscular diagnosis, who absolve an inpatient stay in the rehabilitation center of&#xD;
      the University Chilren's Hospital Zurich, Switzerland.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">January 31, 2016</completion_date>
  <primary_completion_date type="Actual">January 31, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Functional Mobility Scale (FMS)</measure>
    <time_frame>Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with measurements at admission and discharge.</time_frame>
    <description>The questionnaire is filled in independently by the parents, the primary nurse as well as the physiotherapist of each child.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gillette Functional Assessment Questionnaire - Walking Scale (GFAQ)</measure>
    <time_frame>Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with measurements at admission and discharge.</time_frame>
    <description>The questionnaire is filled in independently by the parents, the primary nurse as well as the physiotherapist of each child.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Global Rating Scale (GRS)</measure>
    <time_frame>Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with only one measurement at discharge.</time_frame>
    <description>A global rating on the perceived change of the child's functional mobility over the rehabilitation period and whether this change is perceived as meaningful or not; on a 5-point Likert scale, scored by the parents and the physiotherapist.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Functional Independence Measure for Children (WeeFIM)</measure>
    <time_frame>Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with measurements at admission and discharge.</time_frame>
    <description>The WeeFIM-Item Locomotion (Walking) is scored by the primary nurse.</description>
  </other_outcome>
  <other_outcome>
    <measure>10-Meter Walk Test (10MWT)</measure>
    <time_frame>Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with only one measurement at discharge.</time_frame>
    <description>For the evaluation of the construct validity of the FMS and the GFAQ, the 10MWT comfortable speed as well as maximal speed will be performed shortly before discharge on a 14-meter long track with standardized instructions.</description>
  </other_outcome>
  <other_outcome>
    <measure>6-Minute walk test (6MinWT)</measure>
    <time_frame>Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with only one measurement at discharge.</time_frame>
    <description>For the evaluation of the construct validity of the FMS and the GFAQ, the 6MinWT is performed shortly before discharge on a 30-meter long track with standardized instructions.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">72</enrollment>
  <condition>Psychometrics of Two Translated Measurement Tools</condition>
  <arm_group>
    <arm_group_label>Gait rehabilitation</arm_group_label>
    <description>Multi-modal therapy program including physiotherapy with the aim of gait improvement, Lokomat or treadmill training, strength training, sports therapy.&#xD;
Frequency and intensity are individually assigned.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Gait rehabilitation</intervention_name>
    <arm_group_label>Gait rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children with neuromuscular diagnoses, who are inpatients in the rehabilitation center of&#xD;
        the University Children's Hospital Zurich in Affoltern am Albis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Neuromuscular diagnosis&#xD;
&#xD;
          -  Age: 6-18 years&#xD;
&#xD;
          -  Rehabilitation goal = improvement of walking abilities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children's whose parents are not German-speaking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Corinne Ammann-Reiffer, MPTSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Children's Hospital Zurich, Rehabilitation Center Affoltern</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Children's Hospital Zurich, Rehabilitation Center</name>
      <address>
        <city>Affoltern am Albis</city>
        <zip>CH-8910</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>September 1, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>November 4, 2020</last_update_submitted>
  <last_update_submitted_qc>November 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Outcome Assessment</keyword>
  <keyword>Gait</keyword>
  <keyword>Neuromuscular Diseases</keyword>
  <keyword>Psychometrics</keyword>
  <keyword>Clinical Assessment Tools</keyword>
  <!-- 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/NCT02237222
org study id: GaitPerformance_2014
nct id: NCT02237222
lead sponsor: 
has dmc: No
The aims of this project are to evaluate the psychometric properties of the German versions
      of the two performance questionnaires 'Functional Mobility Scale' (FMS) and 'Gillette
      Functional Assessment Questionnaire - walking scale' (GFAQ) in children between 6-18 years
      with a neuromuscular diagnosis.
The German versions of the two questionnaires 'Functional Mobility Scale' (FMS) and 'Gillette
      Functional Assessment Questionnaire - walking scale' (GFAQ) are evaluated in terms of
      construct validity, inter- and intra-rater reliability as well as responsiveness in children
      with a neuromuscular diagnosis, who absolve an inpatient stay in the rehabilitation center of
      the University Chilren's Hospital Zurich, Switzerland.
observational model: Case-Only
time perspective: Prospective
measure: Functional Mobility Scale (FMS)
time frame: Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with measurements at admission and discharge.
description: The questionnaire is filled in independently by the parents, the primary nurse as well as the physiotherapist of each child.
measure: Gillette Functional Assessment Questionnaire - Walking Scale (GFAQ)
time frame: Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with measurements at admission and discharge.
description: The questionnaire is filled in independently by the parents, the primary nurse as well as the physiotherapist of each child.
measure: Global Rating Scale (GRS)
time frame: Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with only one measurement at discharge.
description: A global rating on the perceived change of the child's functional mobility over the rehabilitation period and whether this change is perceived as meaningful or not; on a 5-point Likert scale, scored by the parents and the physiotherapist.
measure: Functional Independence Measure for Children (WeeFIM)
time frame: Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with measurements at admission and discharge.
description: The WeeFIM-Item Locomotion (Walking) is scored by the primary nurse.
measure: 10-Meter Walk Test (10MWT)
time frame: Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with only one measurement at discharge.
description: For the evaluation of the construct validity of the FMS and the GFAQ, the 10MWT comfortable speed as well as maximal speed will be performed shortly before discharge on a 14-meter long track with standardized instructions.
measure: 6-Minute walk test (6MinWT)
time frame: Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with only one measurement at discharge.
description: For the evaluation of the construct validity of the FMS and the GFAQ, the 6MinWT is performed shortly before discharge on a 30-meter long track with standardized instructions.
arm group label: Gait rehabilitation
description: Multi-modal therapy program including physiotherapy with the aim of gait improvement, Lokomat or treadmill training, strength training, sports therapy.
Frequency and intensity are individually assigned.
intervention type: Other
intervention name: Gait rehabilitation
arm group label: Gait rehabilitation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 18 Years
healthy volunteers: No
last name: Corinne Ammann-Reiffer, MPTSc
role: Principal Investigator
affiliation: University Children's Hospital Zurich, Rehabilitation Center Affoltern
facility: 
country: Switzerland
responsible party type: Sponsor