Visceral Mobilization and Functional Constipation in Stroke Survivors: a Randomized, Controlled, Double-blind, Clinical Trial

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.