<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/NCT04444414</url>
  </required_header>
  <id_info>
    <org_study_id>ID0030</org_study_id>
    <nct_id>NCT04444414</nct_id>
  </id_info>
  <brief_title>Manual Therapy on Balance and Mood States</brief_title>
  <acronym>MTBMood</acronym>
  <official_title>Effect of a Manual Therapy Protocol on Balance and Mood States</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Valencia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Valencia</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 aims of this study was to compare the effectiveness of a protocol of manual therapy on&#xD;
      the static balance, dynamic balance and mood states in health participants. This study will&#xD;
      consist of a randomized controlled trial. Participants will be healthy subjects divided into&#xD;
      2 groups, being an experimental group that will receive a manual therapy session and a&#xD;
      control group without treatment. It will be evaluated at the start of the study, after&#xD;
      treatment and one week later.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background&#xD;
&#xD;
      Evidence suggest that the application of manual therapy could be effective in multiple&#xD;
      pathologies, but there are few studies which have investigated the effectiveness of manual&#xD;
      therapy in to balance and mood states.&#xD;
&#xD;
      Objective To compare the effectiveness of a protocol of manual therapy on the static balance,&#xD;
      dynamic balance and mood states in health participants.&#xD;
&#xD;
      Metods&#xD;
&#xD;
      This is a randomized controlled trial which will be carried out with young adults. The sample&#xD;
      will be divided into 2 groups: a) experimental group that will receive a manual therapy&#xD;
      session; b) a control group without treatment. All subjects signed the informed consent and&#xD;
      confidentiality of the data was reserved according to the Helsinki declaration. The&#xD;
      treatments were carried out in the laboratories of the University of Valencia and the project&#xD;
      was approved by the institution's ethics committee.&#xD;
&#xD;
      The experimental group to receive manual therapy (Bilateral manipulation lumbosacral, hip&#xD;
      joint gapping, stretching the hip rotators with hip and knee flexion, femorotibial gapping,&#xD;
      decompression of connective tissue of the patellofemoral region, internal and external joint&#xD;
      line opening in laterality, mobilization of the base of the fibula, tibiofibular-talus&#xD;
      gapping, and muscle strengthening). The control group will not receive treatment and only&#xD;
      evaluations will be performed.&#xD;
&#xD;
      Outcomes&#xD;
&#xD;
      The evaluations will consist of the following variables: Star Excursion Balance Test (SEBT),&#xD;
      Unipedal Stance Test (UPST), Patient Global Impression of Change (PGIC) and POMS (Profile Of&#xD;
      Mood States). Evaluations will be carried out at three times: at the beginning of the study,&#xD;
      after treatment and one week later.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">November 1, 2020</completion_date>
  <primary_completion_date type="Actual">August 15, 2020</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>A randomized controlled trial with 2 groups (experimental and control)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The subject does not know the group that belonged The evaluator and therapist were different people</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Star Excursion Balance Test (SEBT)</measure>
    <time_frame>1-week</time_frame>
    <description>It consists of reaching the lower limb as much as possible, in a standing position, while the other lower limb is kept on a stable support base, at a certain point. The reaches of the leg are evaluated using three determined directions, such as the anterior, the postero-medial and the postero-lateral.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Unipedal Stance Test (UPST)</measure>
    <time_frame>1-week</time_frame>
    <description>It consists of a test to measure static balance. Subjects who focus on a fixed point that is marked on the wall and perform the single-legged support. Before lifting the lower limb to be assessed, which will determine the start of the test, the subjects have to cross their arms at chest level, placing their hands on the opposite shoulders. When the subject is ready, close the eyes and raise the lower limb, and the time it is capable of holding is measured with a stopwatch. It is performed later with the other leg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Change (PGIC)</measure>
    <time_frame>1-week</time_frame>
    <description>reflects the patient's belief about the effect of the treatment applied. This tool evaluates this perception on a scale that ranges from 1 (the patient is much better) to 7 (the patient is much worse). It also consists of a visual analog scale that classified the improvement from 0 to 10, with the first value being a very good improvement and the second being a significant worsening after treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>POMS (Profile Of Mood States)</measure>
    <time_frame>1-week</time_frame>
    <description>The POMS is a questionnaire which aims to measure the state of mind. It consists of 58 items, valued using a Likert-type format, with 5 possible response alternatives. From this test, a general index of mood alteration and thirst can be extracted, partially measured: Tension, Depression, Cholera, Vigor, Fatigue and Confusion. Although the POMS has been described as a redundant ladder, it appears to be a multidimensional instrument, with high internal consistency and a relatively stable factor structure.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Young Adult</condition>
  <arm_group>
    <arm_group_label>Manual Therapy group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bilateral manipulation lumbosacral, hip joint gapping, stretching the hip rotators with hip and knee flexion, femorotibial gapping, decompression of connective tissue of the patellofemoral region, internal and external joint line opening in laterality, mobilization of the base of the fibula, tibiofibular-talus gapping, and muscle strengthening.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>They received no treatment, they just went to the evaluations.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual therapy</intervention_name>
    <description>bilateral manipulation lumbosacral, hip joint gapping, stretching the hip rotators with hip and knee flexion, femorotibial gapping, decompression of connective tissue of the patellofemoral region, internal and external joint line opening in laterality, mobilization of the base of the fibula, tibiofibular-talus gapping, and muscle strengthening.</description>
    <arm_group_label>Manual Therapy group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>The control group received no treatment, they only attended the evaluations.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 and 30 years&#xD;
&#xD;
          -  That they can take all the tests from the study evaluations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those who are doing some balance training program.&#xD;
&#xD;
          -  Individuals who have some deterioration in balance, regardless of whether the cause is&#xD;
             the vestibular system, the visual, proprioceptive, any surgery.&#xD;
&#xD;
          -  Participants suffering from tingling or numbness.&#xD;
&#xD;
          -  Those who have pain in the lower limbs greater than 3 on the Visual Analog Scale.&#xD;
&#xD;
          -  That the lower limbs or in the lumbosacral region have orthopedic problems or&#xD;
             traumatic injuries, they will not be able to participate either, including as such&#xD;
             scoliosis, ligament pathologies, osteoarthritis, prostheses.&#xD;
&#xD;
          -  Pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Gemma Espí</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Espi-Lopez GV, Serra-Ano P, Vicent-Ferrando J, Sanchez-Moreno-Giner M, Arias-Buria JL, Cleland J, Fernandez-de-Las-Penas C. Effectiveness of Inclusion of Dry Needling in a Multimodal Therapy Program for Patellofemoral Pain: A Randomized Parallel-Group Trial. J Orthop Sports Phys Ther. 2017 Jun;47(6):392-401. doi: 10.2519/jospt.2017.7389. Epub 2017 May 13.</citation>
    <PMID>28504067</PMID>
  </reference>
  <reference>
    <citation>Espi-Lopez GV, Lopez-Martinez S, Ingles M, Serra-Ano P, Aguilar-Rodriguez M. Effect of manual therapy versus proprioceptive neuromuscular facilitation in dynamic balance, mobility and flexibility in field hockey players. A randomized controlled trial. Phys Ther Sport. 2018 Jul;32:173-179. doi: 10.1016/j.ptsp.2018.04.017. Epub 2018 Apr 22.</citation>
    <PMID>29793126</PMID>
  </reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>January 9, 2023</last_update_submitted>
  <last_update_submitted_qc>January 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Valencia</investigator_affiliation>
    <investigator_full_name>GEMMA V ESPÍ LÓPEZ, PhD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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/NCT04444414
org study id: ID0030
nct id: NCT04444414
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aims of this study was to compare the effectiveness of a protocol of manual therapy on
      the static balance, dynamic balance and mood states in health participants. This study will
      consist of a randomized controlled trial. Participants will be healthy subjects divided into
      2 groups, being an experimental group that will receive a manual therapy session and a
      control group without treatment. It will be evaluated at the start of the study, after
      treatment and one week later.
Background

      Evidence suggest that the application of manual therapy could be effective in multiple
      pathologies, but there are few studies which have investigated the effectiveness of manual
      therapy in to balance and mood states.

      Objective To compare the effectiveness of a protocol of manual therapy on the static balance,
      dynamic balance and mood states in health participants.

      Metods

      This is a randomized controlled trial which will be carried out with young adults. The sample
      will be divided into 2 groups: a) experimental group that will receive a manual therapy
      session; b) a control group without treatment. All subjects signed the informed consent and
      confidentiality of the data was reserved according to the Helsinki declaration. The
      treatments were carried out in the laboratories of the University of Valencia and the project
      was approved by the institution's ethics committee.

      The experimental group to receive manual therapy (Bilateral manipulation lumbosacral, hip
      joint gapping, stretching the hip rotators with hip and knee flexion, femorotibial gapping,
      decompression of connective tissue of the patellofemoral region, internal and external joint
      line opening in laterality, mobilization of the base of the fibula, tibiofibular-talus
      gapping, and muscle strengthening). The control group will not receive treatment and only
      evaluations will be performed.

      Outcomes

      The evaluations will consist of the following variables: Star Excursion Balance Test (SEBT),
      Unipedal Stance Test (UPST), Patient Global Impression of Change (PGIC) and POMS (Profile Of
      Mood States). Evaluations will be carried out at three times: at the beginning of the study,
      after treatment and one week later.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A randomized controlled trial with 2 groups (experimental and control)
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: The subject does not know the group that belonged The evaluator and therapist were different people
measure: Star Excursion Balance Test (SEBT)
time frame: 1-week
description: It consists of reaching the lower limb as much as possible, in a standing position, while the other lower limb is kept on a stable support base, at a certain point. The reaches of the leg are evaluated using three determined directions, such as the anterior, the postero-medial and the postero-lateral.
measure: Unipedal Stance Test (UPST)
time frame: 1-week
description: It consists of a test to measure static balance. Subjects who focus on a fixed point that is marked on the wall and perform the single-legged support. Before lifting the lower limb to be assessed, which will determine the start of the test, the subjects have to cross their arms at chest level, placing their hands on the opposite shoulders. When the subject is ready, close the eyes and raise the lower limb, and the time it is capable of holding is measured with a stopwatch. It is performed later with the other leg
measure: Patient Global Impression of Change (PGIC)
time frame: 1-week
description: reflects the patient's belief about the effect of the treatment applied. This tool evaluates this perception on a scale that ranges from 1 (the patient is much better) to 7 (the patient is much worse). It also consists of a visual analog scale that classified the improvement from 0 to 10, with the first value being a very good improvement and the second being a significant worsening after treatment.
measure: POMS (Profile Of Mood States)
time frame: 1-week
description: The POMS is a questionnaire which aims to measure the state of mind. It consists of 58 items, valued using a Likert-type format, with 5 possible response alternatives. From this test, a general index of mood alteration and thirst can be extracted, partially measured: Tension, Depression, Cholera, Vigor, Fatigue and Confusion. Although the POMS has been described as a redundant ladder, it appears to be a multidimensional instrument, with high internal consistency and a relatively stable factor structure.
arm group label: Manual Therapy group
arm group type: Experimental
description: Bilateral manipulation lumbosacral, hip joint gapping, stretching the hip rotators with hip and knee flexion, femorotibial gapping, decompression of connective tissue of the patellofemoral region, internal and external joint line opening in laterality, mobilization of the base of the fibula, tibiofibular-talus gapping, and muscle strengthening.
arm group label: Control group
arm group type: Other
description: They received no treatment, they just went to the evaluations.
intervention type: Other
intervention name: Manual therapy
description: bilateral manipulation lumbosacral, hip joint gapping, stretching the hip rotators with hip and knee flexion, femorotibial gapping, decompression of connective tissue of the patellofemoral region, internal and external joint line opening in laterality, mobilization of the base of the fibula, tibiofibular-talus gapping, and muscle strengthening.
arm group label: Manual Therapy group
intervention type: Other
intervention name: Control group
description: The control group received no treatment, they only attended the evaluations.
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
citation: Espi-Lopez GV, Serra-Ano P, Vicent-Ferrando J, Sanchez-Moreno-Giner M, Arias-Buria JL, Cleland J, Fernandez-de-Las-Penas C. Effectiveness of Inclusion of Dry Needling in a Multimodal Therapy Program for Patellofemoral Pain: A Randomized Parallel-Group Trial. J Orthop Sports Phys Ther. 2017 Jun;47(6):392-401. doi: 10.2519/jospt.2017.7389. Epub 2017 May 13.
PMID: 28504067
citation: Espi-Lopez GV, Lopez-Martinez S, Ingles M, Serra-Ano P, Aguilar-Rodriguez M. Effect of manual therapy versus proprioceptive neuromuscular facilitation in dynamic balance, mobility and flexibility in field hockey players. A randomized controlled trial. Phys Ther Sport. 2018 Jul;32:173-179. doi: 10.1016/j.ptsp.2018.04.017. Epub 2018 Apr 22.
PMID: 29793126
responsible party type: Principal Investigator
investigator affiliation: University of Valencia
investigator full name: GEMMA V ESPÍ LÓPEZ, PhD
investigator title: Principal Investigator
sharing ipd: No