<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/NCT03801772</url>
  </required_header>
  <id_info>
    <org_study_id>AultmanRA2018.10.AF</org_study_id>
    <nct_id>NCT03801772</nct_id>
  </id_info>
  <brief_title>Effects of a Metronome on Functional Outcomes in Aquatic Therapy</brief_title>
  <official_title>Effects of a Metronome on Functional Outcomes in Aquatic Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aultman Health Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aultman Health Foundation</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 purpose of this study is to determine if the use of a pacing device, a metronome,&#xD;
      improves functional outcome measures in aquatic therapy when compared to a control group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 21, 2019</start_date>
  <completion_date type="Actual">April 16, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>participants are assigned to one of two or more groups in parallel for the duration of the study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Single Blind: one party, either the investigator or participant, is unaware of the intervention assignment; also called single-masked study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change between initial 30 second sit to stand measure and final measurement</measure>
    <time_frame>Initial evaluation and up to 8 weeks</time_frame>
    <description>Patient stands and sits as many times as they can in 30 seconds. The number of repetitions is recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from the initial level reported on the Numerical Pain Rating Scale and the final reported level.</measure>
    <time_frame>Initial evaluation and up to 8 weeks</time_frame>
    <description>Pain level is reported on a 0 -10 scale with 0 being no pain and 10 being the highest level of pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Rating of Change</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>Patient rates their improvement compared to the start of treatment from (-)7 [very much worse] to (+)7 [ completely recovered with &quot;0&quot; (zero) being unchanged.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Exercise Therapy</condition>
  <arm_group>
    <arm_group_label>Metronome</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm will be using the metronome as a pacing device during aquatic exercises.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The patients will be educated on proper performance of aquatic exercises following normal physical therapy procedures. Patients will start with 10-20 repetitions of the exercises depending on their physical ability and progressed as the patient's strength and endurance improve. Each session will last approximately 30 to 45 minutes. The BORG scale (a valid, subjective measure of perceived exertion) will be used as a monitoring device to ensure that a desired level of exercise intensity is reached. The desired level is a score between 12 and 16. The patients will be asked to rate their level of exertion at the end of each session. Intensity of the exercises will be adjusted the next session if the patient's reported level of exertion does not fall within the desired range. The pain rating and the BORG number will be recorded for both groups in the chart and flow</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Metronome</intervention_name>
    <description>Pacing aquatic exercises to the beats per minute of a metronome. The metronome will be adjusted to each patient's pain free exertion level. Patients will start with 10-20 repetitions of the exercises depending on their physical ability. The repetitions will be progressed as the patient's strength and endurance improve and noted in the chart and the flow sheet. The metronome will be synchronized during their second aquatic therapy treatment. The beats per minute (BPM) will be increased on the metronome during the series of treatments until the patient can no longer maintain proper technique with the exercises. The exercises will continue at this BPM during future visits. The patient will be instructed to keep pace with the beat of the metronome for the duration of the exercise.</description>
    <arm_group_label>Metronome</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients over the age of 18 assigned to aquatic therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who identify themselves as pregnant on the clinics intake sheet.&#xD;
&#xD;
          -  Anyone unable to hear the beats of the metronome.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Aultman Tusc Therapy</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>September 1, 2021</last_update_submitted>
  <last_update_submitted_qc>September 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aultman Health Foundation</investigator_affiliation>
    <investigator_full_name>Dan Fomich</investigator_full_name>
    <investigator_title>Physical Therapist Assistant</investigator_title>
  </responsible_party>
  <keyword>Aquatic Therapy</keyword>
  <keyword>Hydrotherapy</keyword>
  <keyword>Pool Therapy</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 14, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT03801772/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03801772
org study id: AultmanRA2018.10.AF
nct id: NCT03801772
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine if the use of a pacing device, a metronome,
      improves functional outcome measures in aquatic therapy when compared to a control group.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: participants are assigned to one of two or more groups in parallel for the duration of the study
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Single Blind: one party, either the investigator or participant, is unaware of the intervention assignment; also called single-masked study.
measure: Change between initial 30 second sit to stand measure and final measurement
time frame: Initial evaluation and up to 8 weeks
description: Patient stands and sits as many times as they can in 30 seconds. The number of repetitions is recorded.
measure: Change from the initial level reported on the Numerical Pain Rating Scale and the final reported level.
time frame: Initial evaluation and up to 8 weeks
description: Pain level is reported on a 0 -10 scale with 0 being no pain and 10 being the highest level of pain.
measure: Global Rating of Change
time frame: Up to 8 weeks
description: Patient rates their improvement compared to the start of treatment from (-)7 [very much worse] to (+)7 [ completely recovered with "0" (zero) being unchanged.
arm group label: Metronome
arm group type: Active Comparator
description: This arm will be using the metronome as a pacing device during aquatic exercises.
arm group label: Control
arm group type: No Intervention
description: The patients will be educated on proper performance of aquatic exercises following normal physical therapy procedures. Patients will start with 10-20 repetitions of the exercises depending on their physical ability and progressed as the patient's strength and endurance improve. Each session will last approximately 30 to 45 minutes. The BORG scale (a valid, subjective measure of perceived exertion) will be used as a monitoring device to ensure that a desired level of exercise intensity is reached. The desired level is a score between 12 and 16. The patients will be asked to rate their level of exertion at the end of each session. Intensity of the exercises will be adjusted the next session if the patient's reported level of exertion does not fall within the desired range. The pain rating and the BORG number will be recorded for both groups in the chart and flow
intervention type: Device
intervention name: Metronome
description: Pacing aquatic exercises to the beats per minute of a metronome. The metronome will be adjusted to each patient's pain free exertion level. Patients will start with 10-20 repetitions of the exercises depending on their physical ability. The repetitions will be progressed as the patient's strength and endurance improve and noted in the chart and the flow sheet. The metronome will be synchronized during their second aquatic therapy treatment. The beats per minute (BPM) will be increased on the metronome during the series of treatments until the patient can no longer maintain proper technique with the exercises. The exercises will continue at this BPM during future visits. The patient will be instructed to keep pace with the beat of the metronome for the duration of the exercise.
arm group label: Metronome
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Aultman Health Foundation
investigator full name: Dan Fomich
investigator title: Physical Therapist Assistant
sharing ipd: No
provided document: 