Osteopathic Manipulative Treatment for Constipation in People With Rett Syndrome

NCT05687214 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-02-01

No results posted yet for this study

Summary

Constipation consists of bowel symptoms characterized by difficulty or infrequency passage of stool, stiff stool, or a feeling of incomplete evacuation. However, its impact goes far beyond this definition. Constipation negatively impacts the quality of life (QoL) of children and adults suffering from this condition, affecting mental and physical-related QoL. Additionally, a negative impact of constipation on QoL was found in parents carrying children with constipation, affecting family functioning.

People with an intellectual disability present a constipation rate of over 33%. Rett syndrome (RTT) is a complex neurodevelopmental disorder affecting about 1/10,000 females and a few males worldwide. Chronic constipation is persistent in people with RTT, with a reported prevalence higher than 74%.

Specific recommendations for constipation management in RTT were developed, including behavioral, pharmacological, and surgical considerations. Recently, the literature has been enriched with papers describing the osteopathic treatment efficacy in reducing constipation. Emerging literature reported the efficacy of OMT in reducing constipation symptoms and improving QoL in typically developed people, as well as in children with disability. The present study aims to evaluate the efficacy of a specific OMT for managing chronic constipation in people with RTT and its impact on primary caregivers' quality of life.

Research questions:

* Can an OMT improve the constipation of people with RTT, increasing the frequency of bowel movements?
* Can the effects of an OMT aimed at reducing the constipation symptoms in people with RTT positively impact the participants' parents' constipation-related QoL?

Twelve individuals with RTT and their families will be recruited to participate in this single-blind parallel group-randomized study. Participants will be randomly divided into an experimental group (EG) and a control group (CG). After the preliminary evaluations, each participant will undergo eight OMT carried out weekly for eight weeks. The OMT will aim to facilitate bowel movements by increasing blood flow through the abdomen. At the end of the treatment, the participants will repeat the evaluation conducted before the OMT, and the collected data will be analyzed.

Conditions

Interventions

OTHER

Osteopathic manipulative treatment

Each participant in the experimental group will receive eight osteopathic manipulative treatments. Each treatment will include the following manipulations: * Pompage Cv4; * Occipital-sternal technique; * Relaxining manipulation of the diaphragmatic domes; * Pelvic and abdominal diaphragm synchronization; * Dynamogenic technique; * Mesenteric traction; * Release of colic angles; * Manipulation and mobilization of the sacrum.

Sponsors & Collaborators

  • Associazione Italiana Rett (AIRETT)

    collaborator UNKNOWN
  • Ariel University

    lead OTHER

Principal Investigators

  • Rosa Angela Fabio, PhD · Department of Clinical and Experimental Medicine, University of Messina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-16
Primary Completion
2023-01-27
Completion
2023-01-27

Countries

  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05687214 on ClinicalTrials.gov