Visceral Mobilization and Functional Constipation in Stroke Survivors
Condition: Stroke Rehabilitation
MeSH terms: Stroke; Constipation
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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).
    

Intervention name(s): visceral mobilization
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment