<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/NCT03031977</url>
  </required_header>
  <id_info>
    <org_study_id>Hugo Fisioterapia</org_study_id>
    <nct_id>NCT03031977</nct_id>
  </id_info>
  <brief_title>Visceral Mobilization and Functional Constipation in Stroke Survivors</brief_title>
  <official_title>Visceral Mobilization and Functional Constipation in Stroke Survivors: a Randomized, Controlled, Double-blind, Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sorocaba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sorocaba</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the present study was to evaluate the effect of visceral mobilization on symptoms&#xD;
      of functional constipation and static balance in stroke survivors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Procedures&#xD;
&#xD;
      All volunteers received clarifications with regard to the procedures and were informed that&#xD;
      the procedures would not affect their health. The volunteers were assured that all&#xD;
      information would be confidential and their privacy would remain protected. All volunteers&#xD;
      who agreed to participate in the study signed a statement of informed consent in compliance&#xD;
      with Resolution 196/96 of the Brazilian National Board of Health.&#xD;
&#xD;
      Sham intervention procedures were always performed in combination with active conventional&#xD;
      therapy, which lessened the impact the sham procedure on the patient. Moreover, the patients&#xD;
      were informed of the use of this procedure prior to the onset of the study.&#xD;
&#xD;
      Randomization, evaluation and intervention&#xD;
&#xD;
      Thirty individuals met the eligibility criteria and were randomly allocated to one of the two&#xD;
      study groups using a block randomization method. Fifteen patients were allocated to each&#xD;
      group: Experimental group - conventional physical therapy and visceral mobilization; control&#xD;
      group: conventional physical therapy and sham mobilization. Block randomization involved the&#xD;
      use of sealed opaque envelopes, each containing a card stipulating one of the two groups.&#xD;
      After the pre-intervention evaluation, the participant was allocated to a group by opening an&#xD;
      envelope. This process was performed by a member of the research team who was not involved in&#xD;
      the recruitment process or development of the study.&#xD;
&#xD;
      Evaluations were performed on three occasions: 1) prior to the intervention; 2) immediately&#xD;
      after the first session; and 3) one week after the last session. All specific evaluation&#xD;
      procedures were performed during the pre-intervention and post-intervention (one week after&#xD;
      the sessions) evaluations, whereas only the computerized plantar pressure evaluation was&#xD;
      performed at the second evaluation (immediately after the first session). The researcher in&#xD;
      charge of the evaluations was blinded to the objectives of the study and did not take part in&#xD;
      the intervention protocols. Moreover, the order of the evaluations was randomized to avoid&#xD;
      the effect of standardization.&#xD;
&#xD;
      First, an identification chart was filled out with information on age, sex, date of stroke&#xD;
      episode and onset of constipation. Anthropometric data (body mass and height) were also&#xD;
      measured and recorded. The specific evaluation procedures consisted of the use of an&#xD;
      intestinal symptoms rating scale(16) (primary outcome) and plantar pressure evaluation&#xD;
      (secondary outcome).&#xD;
&#xD;
      The ten-item intestinal symptoms rating scale was used to measure the intensity of intestinal&#xD;
      symptoms. On this scale, each item is scored from 0 to 4 points. Item 1 regards the frequency&#xD;
      of bowel movements and Items 2 to 10 address intestinal symptoms. The final scores is&#xD;
      calculated by the mean of the item scores; 0 corresponds to a absence of symptoms and 4&#xD;
      corresponds to the highest intensity of symptoms.(16) The plantar pressure evaluation was&#xD;
      performed using a force plate (Medicapteurs France S-Plate) with 1600 sensors and an&#xD;
      acquisition frequency of 100 images per second. This force plate measures the distribution of&#xD;
      plantar pressure during quiet standing, with quantitative data on anteroposterior and&#xD;
      mediolateral sway (cm) as well as the mean sway velocity (cm/s) in these directions. The&#xD;
      volunteer stood barefoot on the pressure plate in the standing position with arms alongside&#xD;
      the body, gaze fixed on the horizon, lips closed, with the mandible and rest of the body&#xD;
      relaxed. Readings were performed for 50 seconds, the 30 intermediate seconds of which were&#xD;
      used for analysis. The values were recorded using the program provided by the manufacturer&#xD;
      installed on a microcomputer.&#xD;
&#xD;
      Both groups were submitted to general kinesiotherapy with a focus on strengthening,&#xD;
      stretching and proprioception during conventional physical therapy. The experimental group&#xD;
      was also submitted to mobilization of the ascending colon, descending colon, sigmoid colon&#xD;
      and sphincters (cardiac, pyloric, Oddi, duodenojejunal and ileocecal) with the patient in the&#xD;
      supine position, knees flexed, feet supported and abdomen exposed. Contact was made with the&#xD;
      region to be treated, leading it in the direction of immobility, with pressure maintained for&#xD;
      one minute on each region with intensity based on the sensitivity to tension observed on the&#xD;
      feedback of the individual. In the control group, sham mobilization was performed, which&#xD;
      consisted of superficial contact with no pressure on the abdominal region corresponding to&#xD;
      the loops of the large intestine. Five intervention sessions were held over a two-week&#xD;
      period.&#xD;
&#xD;
      Statistical analysis&#xD;
&#xD;
      The data were first submitted to the Kolmogorov-Smirnov test to determine adherence to the&#xD;
      Gaussian curve. The independent t-test was used for the inter-group analysis.&#xD;
      Repeated-measures ANOVA was used for the intra-group analysis under each condition. The&#xD;
      chi-square test was used to evaluate the dispersion of the qualitative variables in the&#xD;
      intra-group and inter-group analyses. A p-value ≤ 0.05 was considered indicative of&#xD;
      statistical significance. The data were organized and tabulated using the Statistical Package&#xD;
      for the Social Sciences (SPSS v.19.0).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>intestinal symptoms rating scale</measure>
    <time_frame>1 month</time_frame>
    <description>The ten-item intestinal symptoms rating scale was used to measure the intensity of intestinal symptoms. On this scale, each item is scored from 0 to 4 points. Item 1 regards the frequency of bowel movements and Items 2 to 10 address intestinal symptoms. The final scores is calculated by the mean of the item scores; 0 corresponds to a absence of symptoms and 4 corresponds to the highest intensity of symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>plantar pressure evaluation</measure>
    <time_frame>1 month</time_frame>
    <description>The plantar pressure evaluation was performed using a force plate (Medicapteurs France S-Plate) with 1600 sensors and an acquisition frequency of 100 images per second. This force plate measures the distribution of plantar pressure during quiet standing, with quantitative data on anteroposterior and mediolateral sway (cm) as well as the mean sway velocity (cm/s) in these directions.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Stroke Rehabilitation</condition>
  <arm_group>
    <arm_group_label>visceral mobilization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Conventional physical therapy and visceral mobilization. The experimental group was also submitted to mobilization of the ascending colon, descending colon, sigmoid colon and sphincters (cardiac, pyloric, Oddi, duodenojejunal and ileocecal) with the patient in the supine position, knees flexed, feet supported and abdomen exposed. Contact was made with the region to be treated, leading it in the direction of immobility, with pressure maintained for one minute on each region with intensity based on the sensitivity to tension observed on the feedback of the individual.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham mobilization</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Conventional physical therapy and sham mobilization. In the control group, sham mobilization was performed, which consisted of superficial contact with no pressure on the abdominal region corresponding to the loops of the large intestine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>visceral mobilization</intervention_name>
    <arm_group_label>sham mobilization</arm_group_label>
    <arm_group_label>visceral mobilization</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients aged 40 to 70 years having suffered a stroke more than one&#xD;
             year earlier with hemiparesis secondary to a single unilateral event&#xD;
&#xD;
          -  The capacity for independent gait and a complaint of chronic constipation for more&#xD;
             than six months in accordance with the definition of functional constipation described&#xD;
             by the Rome III Consensus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Incision or tumor in the abdominal region&#xD;
&#xD;
          -  fractures&#xD;
&#xD;
          -  rheumatic disease&#xD;
&#xD;
          -  infectious process in the acute phase&#xD;
&#xD;
          -  inability to understand the proposed evaluations&#xD;
&#xD;
          -  inability to walk or maintain balance in an independent manner&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>January 23, 2017</last_update_submitted>
  <last_update_submitted_qc>January 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sorocaba</investigator_affiliation>
    <investigator_full_name>Luciane Cruz Lopes</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Constipation</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/NCT03031977
org study id: Hugo Fisioterapia
nct id: NCT03031977
lead sponsor: 
has dmc: Yes
The aim of the present study was to evaluate the effect of visceral mobilization on symptoms
      of functional constipation and static balance in stroke survivors.
Procedures

      All volunteers received clarifications with regard to the procedures and were informed that
      the procedures would not affect their health. The volunteers were assured that all
      information would be confidential and their privacy would remain protected. All volunteers
      who agreed to participate in the study signed a statement of informed consent in compliance
      with Resolution 196/96 of the Brazilian National Board of Health.

      Sham intervention procedures were always performed in combination with active conventional
      therapy, which lessened the impact the sham procedure on the patient. Moreover, the patients
      were informed of the use of this procedure prior to the onset of the study.

      Randomization, evaluation and intervention

      Thirty individuals met the eligibility criteria and were randomly allocated to one of the two
      study groups using a block randomization method. Fifteen patients were allocated to each
      group: Experimental group - conventional physical therapy and visceral mobilization; control
      group: conventional physical therapy and sham mobilization. Block randomization involved the
      use of sealed opaque envelopes, each containing a card stipulating one of the two groups.
      After the pre-intervention evaluation, the participant was allocated to a group by opening an
      envelope. This process was performed by a member of the research team who was not involved in
      the recruitment process or development of the study.

      Evaluations were performed on three occasions: 1) prior to the intervention; 2) immediately
      after the first session; and 3) one week after the last session. All specific evaluation
      procedures were performed during the pre-intervention and post-intervention (one week after
      the sessions) evaluations, whereas only the computerized plantar pressure evaluation was
      performed at the second evaluation (immediately after the first session). The researcher in
      charge of the evaluations was blinded to the objectives of the study and did not take part in
      the intervention protocols. Moreover, the order of the evaluations was randomized to avoid
      the effect of standardization.

      First, an identification chart was filled out with information on age, sex, date of stroke
      episode and onset of constipation. Anthropometric data (body mass and height) were also
      measured and recorded. The specific evaluation procedures consisted of the use of an
      intestinal symptoms rating scale(16) (primary outcome) and plantar pressure evaluation
      (secondary outcome).

      The ten-item intestinal symptoms rating scale was used to measure the intensity of intestinal
      symptoms. On this scale, each item is scored from 0 to 4 points. Item 1 regards the frequency
      of bowel movements and Items 2 to 10 address intestinal symptoms. The final scores is
      calculated by the mean of the item scores; 0 corresponds to a absence of symptoms and 4
      corresponds to the highest intensity of symptoms.(16) The plantar pressure evaluation was
      performed using a force plate (Medicapteurs France S-Plate) with 1600 sensors and an
      acquisition frequency of 100 images per second. This force plate measures the distribution of
      plantar pressure during quiet standing, with quantitative data on anteroposterior and
      mediolateral sway (cm) as well as the mean sway velocity (cm/s) in these directions. The
      volunteer stood barefoot on the pressure plate in the standing position with arms alongside
      the body, gaze fixed on the horizon, lips closed, with the mandible and rest of the body
      relaxed. Readings were performed for 50 seconds, the 30 intermediate seconds of which were
      used for analysis. The values were recorded using the program provided by the manufacturer
      installed on a microcomputer.

      Both groups were submitted to general kinesiotherapy with a focus on strengthening,
      stretching and proprioception during conventional physical therapy. The experimental group
      was also submitted to mobilization of the ascending colon, descending colon, sigmoid colon
      and sphincters (cardiac, pyloric, Oddi, duodenojejunal and ileocecal) with the patient in the
      supine position, knees flexed, feet supported and abdomen exposed. Contact was made with the
      region to be treated, leading it in the direction of immobility, with pressure maintained for
      one minute on each region with intensity based on the sensitivity to tension observed on the
      feedback of the individual. In the control group, sham mobilization was performed, which
      consisted of superficial contact with no pressure on the abdominal region corresponding to
      the loops of the large intestine. Five intervention sessions were held over a two-week
      period.

      Statistical analysis

      The data were first submitted to the Kolmogorov-Smirnov test to determine adherence to the
      Gaussian curve. The independent t-test was used for the inter-group analysis.
      Repeated-measures ANOVA was used for the intra-group analysis under each condition. The
      chi-square test was used to evaluate the dispersion of the qualitative variables in the
      intra-group and inter-group analyses. A p-value ≤ 0.05 was considered indicative of
      statistical significance. The data were organized and tabulated using the Statistical Package
      for the Social Sciences (SPSS v.19.0).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: intestinal symptoms rating scale
time frame: 1 month
description: The ten-item intestinal symptoms rating scale was used to measure the intensity of intestinal symptoms. On this scale, each item is scored from 0 to 4 points. Item 1 regards the frequency of bowel movements and Items 2 to 10 address intestinal symptoms. The final scores is calculated by the mean of the item scores; 0 corresponds to a absence of symptoms and 4 corresponds to the highest intensity of symptoms.
measure: plantar pressure evaluation
time frame: 1 month
description: The plantar pressure evaluation was performed using a force plate (Medicapteurs France S-Plate) with 1600 sensors and an acquisition frequency of 100 images per second. This force plate measures the distribution of plantar pressure during quiet standing, with quantitative data on anteroposterior and mediolateral sway (cm) as well as the mean sway velocity (cm/s) in these directions.
arm group label: visceral mobilization
arm group type: Experimental
description: Conventional physical therapy and visceral mobilization. The experimental group was also submitted to mobilization of the ascending colon, descending colon, sigmoid colon and sphincters (cardiac, pyloric, Oddi, duodenojejunal and ileocecal) with the patient in the supine position, knees flexed, feet supported and abdomen exposed. Contact was made with the region to be treated, leading it in the direction of immobility, with pressure maintained for one minute on each region with intensity based on the sensitivity to tension observed on the feedback of the individual.
arm group label: sham mobilization
arm group type: Sham Comparator
description: Conventional physical therapy and sham mobilization. In the control group, sham mobilization was performed, which consisted of superficial contact with no pressure on the abdominal region corresponding to the loops of the large intestine.
intervention type: Other
intervention name: visceral mobilization
arm group label: sham mobilization
arm group label: visceral mobilization
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Sorocaba
investigator full name: Luciane Cruz Lopes
investigator title: Clinical Professor
mesh term: Stroke
mesh term: Constipation