Osteopathic Manipulative Treatment for Constipation in People With Rett Syndrome
Primary Purpose
Rett Syndrome
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Osteopathic manipulative treatment
Sponsored by
About this trial
This is an interventional treatment trial for Rett Syndrome
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.
Sites / Locations
- Centro AIRETT Ricerca e Innovazione (CARI)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group
Control Group
Arm Description
Each participant in the experimental group will receive eight weekly osteopathic manipulative treatments within eight weeks. Each treatment session will include several specific manipulations.
Participants in the control group will not receive any treatment.
Outcomes
Primary Outcome Measures
Change in number of evacuations
The number of participants' evacuations collected daily by participants' caregivers
Change in number of evacuations
The number of participants' evacuations collected daily by participants' caregivers
Change in number of evacuations
The number of participants' evacuations collected daily by participants' caregivers
Change in number of enemas and medications
The number of enemas and medication provided to the participants' to simplify or induce the evacuations collected by their caregivers.
Change in number of enemas and medications
The number of enemas and medication provided to the participants' to simplify or induce the evacuations collected by their caregivers.
Change in number of enemas and medications
The number of enemas and medication provided to the participants' to simplify or induce the evacuations collected by their caregivers.
Change in the Modified Constipation Assessment Scale (m-CAS)
The m-CAS is an eight-item scale that measures whether constipation is present and its intensity. A higher score represents more severe constipation. Cronbach α coefficient showed good internal consistency over time (α>0.70). The Pearson product-moment correlation coefficient was used to evaluate test-retest reliability and showed evident acceptance (r=0.93; P<0.001).
Change in theConstipation Scoring System (CSS)
The CSS assesses the severity of constipation with a maximum score of 30 (0 = no constipation, 30 = severe constipation. The scale was initially validated with a 100-subject sample and could correctly detect the absence or presence of constipation in 96% of the subjects, thus representing a sensitive and valid tool.
Change in theConstipation-Related Quality Of Life (CRQOL)
The CRQOL assesses quality-of-life domains affected by constipation. It includes four domains: social impairment, distress, eating habits, and bathroom attitudes. In our study, the primary caregiver filled this scale reporting his feelings concerning the participant's constipation management. The internal consistency of each of the four domains was higher than 0.70 using Cronbach's alpha. Excellent test-retest reliability was demonstrated (α>0.85).
Change in the Short Form Health Survey-12 (SF-12)
The SF-12 is a multidimensional measure of health-related quality of life widely used in clinical trials. The SF-12 was administered to participants' primary caregivers. The Italian version of the SF-12 was validated on a large sample of Italian people showing strong psychometric proprieties.
Secondary Outcome Measures
Change in the tissue tension
The pelvic tissue tension was evaluated as an index of hydration and deep fascial tension. For the assessment, the iliac cavity skin was pinched between the index and thumb fingers, and a score between 0 (normal tissue elasticity) and 4 (adherent, rigid skin, tissue detachment not possible) was assigned based on the tissue elasticity.
Change in the abdomen palpability
It represents an index of abdominal stiffness and refers to the intestinal skein resistance to manual mobilization in the supine position. The right and left colic cords, ileocecal valve, and sigma were mobilized. Based on the perceived tissue consistency and resistance, scores between 0 (soft and treatable abdominal tissue) and 3 (rigid abdomen, tense and painful even in the medium-deep palpation) points were assigned.
Change in the abdominal bloating
It assesses the presence and extent of intestinal gas. It is helpful to have an approximate idea of the intestinal loops' opening (or closing) level. It was assessed by observing the prominence of the four abdominal quadrants in correspondence with the navel, anterior iliac thorns, and costal ramps. And a score between 0 (flat, compressible abdomen) and 4 (globose abdomen, total compressibility not possible) was assigned.
Change in the sacral pad swelling
Its presence can indicate inadequate liquids' reabsorption in the small pelvis by the iliac branches. It is evaluated in the supine position by manual pressure examination of the sacral base. Based on the sacral area swelling, a score between 0 (normally distended sacral area) and 3 (large swelling with lumbar-sacral area tissue inhibition).
Full Information
NCT ID
NCT05687214
First Posted
December 30, 2022
Last Updated
January 30, 2023
Sponsor
Ariel University
Collaborators
Associazione Italiana Rett (AIRETT)
1. Study Identification
Unique Protocol Identification Number
NCT05687214
Brief Title
Osteopathic Manipulative Treatment for Constipation in People With Rett Syndrome
Official Title
Investigation on the Effects of an Osteopathic Manipulative Treatment for Constipation in People With Rett Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 16, 2022 (Actual)
Primary Completion Date
January 27, 2023 (Actual)
Study Completion Date
January 27, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ariel University
Collaborators
Associazione Italiana Rett (AIRETT)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rett Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-blind parallel group-randomized design.
Masking
Outcomes Assessor
Masking Description
The assessors will not know which group the participants were assigned (experimental or control group) at any study stage.
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Each participant in the experimental group will receive eight weekly osteopathic manipulative treatments within eight weeks. Each treatment session will include several specific manipulations.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants in the control group will not receive any treatment.
Intervention Type
Other
Intervention Name(s)
Osteopathic manipulative treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in number of evacuations
Description
The number of participants' evacuations collected daily by participants' caregivers
Time Frame
Every day, for one week, immediately before the intervention phase.
Title
Change in number of evacuations
Description
The number of participants' evacuations collected daily by participants' caregivers
Time Frame
Every day, during the intervention phase (for 8 weeks).
Title
Change in number of evacuations
Description
The number of participants' evacuations collected daily by participants' caregivers
Time Frame
Every day, for one week, immediately after the end of the intervention phase.
Title
Change in number of enemas and medications
Description
The number of enemas and medication provided to the participants' to simplify or induce the evacuations collected by their caregivers.
Time Frame
Every day, for one week, immediately before the intervention phase.
Title
Change in number of enemas and medications
Description
The number of enemas and medication provided to the participants' to simplify or induce the evacuations collected by their caregivers.
Time Frame
Every day, during the intervention phase (for 8 weeks).
Title
Change in number of enemas and medications
Description
The number of enemas and medication provided to the participants' to simplify or induce the evacuations collected by their caregivers.
Time Frame
Every day, for one week, immediately after the end of the intervention phase.
Title
Change in the Modified Constipation Assessment Scale (m-CAS)
Description
The m-CAS is an eight-item scale that measures whether constipation is present and its intensity. A higher score represents more severe constipation. Cronbach α coefficient showed good internal consistency over time (α>0.70). The Pearson product-moment correlation coefficient was used to evaluate test-retest reliability and showed evident acceptance (r=0.93; P<0.001).
Time Frame
15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).
Title
Change in theConstipation Scoring System (CSS)
Description
The CSS assesses the severity of constipation with a maximum score of 30 (0 = no constipation, 30 = severe constipation. The scale was initially validated with a 100-subject sample and could correctly detect the absence or presence of constipation in 96% of the subjects, thus representing a sensitive and valid tool.
Time Frame
15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).
Title
Change in theConstipation-Related Quality Of Life (CRQOL)
Description
The CRQOL assesses quality-of-life domains affected by constipation. It includes four domains: social impairment, distress, eating habits, and bathroom attitudes. In our study, the primary caregiver filled this scale reporting his feelings concerning the participant's constipation management. The internal consistency of each of the four domains was higher than 0.70 using Cronbach's alpha. Excellent test-retest reliability was demonstrated (α>0.85).
Time Frame
15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).
Title
Change in the Short Form Health Survey-12 (SF-12)
Description
The SF-12 is a multidimensional measure of health-related quality of life widely used in clinical trials. The SF-12 was administered to participants' primary caregivers. The Italian version of the SF-12 was validated on a large sample of Italian people showing strong psychometric proprieties.
Time Frame
15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).
Secondary Outcome Measure Information:
Title
Change in the tissue tension
Description
The pelvic tissue tension was evaluated as an index of hydration and deep fascial tension. For the assessment, the iliac cavity skin was pinched between the index and thumb fingers, and a score between 0 (normal tissue elasticity) and 4 (adherent, rigid skin, tissue detachment not possible) was assigned based on the tissue elasticity.
Time Frame
15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).
Title
Change in the abdomen palpability
Description
It represents an index of abdominal stiffness and refers to the intestinal skein resistance to manual mobilization in the supine position. The right and left colic cords, ileocecal valve, and sigma were mobilized. Based on the perceived tissue consistency and resistance, scores between 0 (soft and treatable abdominal tissue) and 3 (rigid abdomen, tense and painful even in the medium-deep palpation) points were assigned.
Time Frame
15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).
Title
Change in the abdominal bloating
Description
It assesses the presence and extent of intestinal gas. It is helpful to have an approximate idea of the intestinal loops' opening (or closing) level. It was assessed by observing the prominence of the four abdominal quadrants in correspondence with the navel, anterior iliac thorns, and costal ramps. And a score between 0 (flat, compressible abdomen) and 4 (globose abdomen, total compressibility not possible) was assigned.
Time Frame
15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).
Title
Change in the sacral pad swelling
Description
Its presence can indicate inadequate liquids' reabsorption in the small pelvis by the iliac branches. It is evaluated in the supine position by manual pressure examination of the sacral base. Based on the sacral area swelling, a score between 0 (normally distended sacral area) and 3 (large swelling with lumbar-sacral area tissue inhibition).
Time Frame
15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosa Angela Fabio, PhD
Organizational Affiliation
Department of Clinical and Experimental Medicine, University of Messina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro AIRETT Ricerca e Innovazione (CARI)
City
Verona
ZIP/Postal Code
37122
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The investigators plan to share the anonymized IPD related to participants' age, and levels of Rett syndrome severity, motor functioning, and daily physical activity. The information will be published as a part of the scientific articles produced after the study ends.
IPD Sharing Time Frame
The IPD will be available if and when scientific articles related to this study are published. Should the data be published, they will be available indefinitely in the scientific literature.
IPD Sharing Access Criteria
The investigators plan to submit scientific articles related to the present study to be published in an open access peer-review scientific journal. Therefore, if the articles are published, the data will be available on the website of the journal in which they were published.
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Osteopathic Manipulative Treatment for Constipation in People With Rett Syndrome
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