NCT03031977

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

1 month

First QC Date

January 16, 2017

Last Update Submit

January 23, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • intestinal symptoms rating scale

    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.

    1 month

Secondary Outcomes (1)

  • plantar pressure evaluation

    1 month

Study Arms (2)

visceral mobilization

EXPERIMENTAL

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.

Other: visceral mobilization

sham mobilization

SHAM COMPARATOR

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.

Other: visceral mobilization

Interventions

sham mobilizationvisceral mobilization

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients aged 40 to 70 years having suffered a stroke more than one year earlier with hemiparesis secondary to a single unilateral event
  • The capacity for independent gait and a complaint of chronic constipation for more than six months in accordance with the definition of functional constipation described by the Rome III Consensus

You may not qualify if:

  • Incision or tumor in the abdominal region
  • fractures
  • rheumatic disease
  • infectious process in the acute phase
  • inability to understand the proposed evaluations
  • inability to walk or maintain balance in an independent manner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Todd CL, Johnson EE, Stewart F, Wallace SA, Bryant A, Woodward S, Norton C. Conservative, physical and surgical interventions for managing faecal incontinence and constipation in adults with central neurological diseases. Cochrane Database Syst Rev. 2024 Oct 29;10(10):CD002115. doi: 10.1002/14651858.CD002115.pub6.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 16, 2017

First Posted

January 26, 2017

Study Start

September 1, 2016

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

January 26, 2017

Record last verified: 2017-01