Osteopathic Manipulative Treatment for Constipation in People With Rett Syndrome

NCT ID: NCT05687214

Last Updated: 2023-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-16
• Study Completion Date: 2023-01-27

Brief 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

Rett Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental group

Each participant in the experimental group will receive eight weekly osteopathic manipulative treatments within eight weeks. Each treatment session will include several specific manipulations.

Group Type: EXPERIMENTAL

Osteopathic manipulative treatment

Intervention Type: OTHER

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.

Control Group

Participants in the control group will not receive any treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• diagnosis of classic Rett syndrome with a mutation of the MECP2 gene;
• matching the ROME IV criteria for constipation;

Exclusion Criteria

• the presence of specific severe heart and cardiovascular diseases;
• the presence of amenorrhea.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Associazione Italiana Rett (AIRETT)

UNKNOWN

Sponsor Role: collaborator

Ariel University

OTHER

Sponsor Role: lead

Responsible Party

Meir Lotan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rosa Angela Fabio, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical and Experimental Medicine, University of Messina

Locations

Centro AIRETT Ricerca e Innovazione (CARI)

Verona, , Italy

Countries

Italy

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Other Identifiers

AU-HEA-ML-20220915

Identifier Type: -

Identifier Source: org_study_id