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Rett SyndromeNCT05687214

Osteopathic Manipulative Treatment for Constipation in People With Rett Syndrome

A study testing Osteopathic manipulative treatment in people with Rett Syndrome, run by Ariel University at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Rett Syndrome
What is being tested?
Osteopathic manipulative treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteItaly
Study dates
16 Nov 2022to 27 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Centro AIRETT Ricerca e Innovazione (CARI)

    Verona, 37122

Other trials in Italy

About this study

Official title: Investigation on the Effects of an Osteopathic Manipulative Treatment for Constipation in People With Rett Syndrome

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%.

Read more

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
Being tested
Osteopathic manipulative treatment
Medical subject headings
Rett Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Osteopathic manipulative treatmentOther

    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.
Study groups in NCT05687214
Study groupRoleWhat they receive
Experimental groupExperimentalEach participant in the experimental group will receive eight weekly osteopathic manipulative treatments within eight weeks. Each treatment session will include several specific manipulations.
Receives: Other: Osteopathic manipulative treatment
Control GroupNo interventionParticipants in the control group will not receive any treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in number of evacuations

    The number of participants' evacuations collected daily by participants' caregivers

    Measured: Every day, for one week, immediately before the intervention phase.

  2. Change in number of evacuations

    The number of participants' evacuations collected daily by participants' caregivers

    Measured: Every day, during the intervention phase (for 8 weeks).

  3. Change in number of evacuations

    The number of participants' evacuations collected daily by participants' caregivers

    Measured: Every day, for one week, immediately after the end of the intervention phase.

  4. 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.

    Measured: Every day, for one week, immediately before the intervention phase.

  5. 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.

    Measured: Every day, during the intervention phase (for 8 weeks).

  6. 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.

    Measured: Every day, for one week, immediately after the end of the intervention phase.

  7. 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).

    Measured: 15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).

  8. 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.

    Measured: 15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).

  9. 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).

    Measured: 15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).

  10. 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.

    Measured: 15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).

Secondary outcomes (4)

  1. 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.

    Measured: 15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).

  2. 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.

    Measured: 15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).

  3. 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.

    Measured: 15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).

  4. 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).

    Measured: 15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2023
  2. Study start16 Nov 2022
  3. Primary completion27 Jan 2023
  4. Study completion27 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single-blind parallel group-randomized design.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05687214
Sponsor's protocol ID
AU-HEA-ML-20220915
Status last verified
Jan 2023
First submitted
30 Dec 2022
Last updated
1 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Bharucha AE, Pemberton JH, Locke GR 3rd. American Gastroenterological Association technical review on constipation. Gastroenterology. 2013 Jan;144(1):218-38. doi: 10.1053/j.gastro.2012.10.028. No abstract available.

    PubMed 23261065

  • Sbahi H, Cash BD. Chronic Constipation: a Review of Current Literature. Curr Gastroenterol Rep. 2015 Dec;17(12):47. doi: 10.1007/s11894-015-0471-z.

    PubMed 26449614

  • Drossman DA. Functional Gastrointestinal Disorders: History, Pathophysiology, Clinical Features and Rome IV. Gastroenterology. 2016 Feb 19:S0016-5085(16)00223-7. doi: 10.1053/j.gastro.2016.02.032. Online ahead of print.

    PubMed 27144617

  • Jani B, Marsicano E. Constipation: Evaluation and Management. Mo Med. 2018 May-Jun;115(3):236-240.

    PubMed 30228729

  • Leung L, Riutta T, Kotecha J, Rosser W. Chronic constipation: an evidence-based review. J Am Board Fam Med. 2011 Jul-Aug;24(4):436-51. doi: 10.3122/jabfm.2011.04.100272.

    PubMed 21737769

  • Vriesman MH, Rajindrajith S, Koppen IJN, van Etten-Jamaludin FS, van Dijk M, Devanarayana NM, Tabbers MM, Benninga MA. Quality of Life in Children with Functional Constipation: A Systematic Review and Meta-Analysis. J Pediatr. 2019 Nov;214:141-150. doi: 10.1016/j.jpeds.2019.06.059. Epub 2019 Aug 6.

    PubMed 31399248

  • Wang C, Shang L, Zhang Y, Tian J, Wang B, Yang X, Sun L, Du C, Jiang X, Xu Y. Impact of functional constipation on health-related quality of life in preschool children and their families in Xi'an, China. PLoS One. 2013 Oct 10;8(10):e77273. doi: 10.1371/journal.pone.0077273. eCollection 2013.

    PubMed 24130872

  • Kaugars AS, Silverman A, Kinservik M, Heinze S, Reinemann L, Sander M, Schneider B, Sood M. Families' perspectives on the effect of constipation and fecal incontinence on quality of life. J Pediatr Gastroenterol Nutr. 2010 Dec;51(6):747-52. doi: 10.1097/MPG.0b013e3181de0651.

    PubMed 20706148

  • Thompson AP, MacDonald SE, Wine E, Scott SD. Understanding Parents' Experiences When Caring for a Child With Functional Constipation: Interpretive Description Study. JMIR Pediatr Parent. 2021 Jan 20;4(1):e24851. doi: 10.2196/24851.

    PubMed 33470939

  • De Hert M, Hudyana H, Dockx L, Bernagie C, Sweers K, Tack J, Leucht S, Peuskens J. Second-generation antipsychotics and constipation: a review of the literature. Eur Psychiatry. 2011 Jan;26(1):34-44. doi: 10.1016/j.eurpsy.2010.03.003. Epub 2010 Jun 9.

    PubMed 20542667

  • Balogh RS, Ouellette-Kuntz H, Brownell M, Colantonio A. Ambulatory Care Sensitive Conditions in Persons with an Intellectual Disability - Development of a Consensus. J Appl Res Intellect Disabil 2011;24:150-8. doi:10.1111/j.1468-3148.2010.00578.x.

  • Bosch J, Van Dyke C, Smith SM, Poulton S. Role of medical conditions in the exacerbation of self-injurious behavior: an exploratory study. Ment Retard. 1997 Apr;35(2):124-30. doi: 10.1352/0047-6765(1997)0352.0.CO;2.

    PubMed 9131872

  • Carr EG, Smith CE. Biological setting events for self-injury. Ment Retard Dev Disabil Res Rev 1995;1:94-8. doi:10.1002/mrdd.1410010204.

  • Christensen TJ, Ringdahl JE, Bosch JJ, Falcomata TS, Luke JR, Andelman MS. Constipation associated with self-injurious and aggressive behavior exhibited by a child diagnosed with autism. Educ Treat Child 2009;32:89-103. doi:10.1353/etc.0.0041.

  • Coleman J, Spurling G. Constipation in people with learning disability. BMJ. 2010 Jan 26;340:c222. doi: 10.1136/bmj.c222. No abstract available.

    PubMed 20103526

Questions about this trial

What is this clinical trial studying?

A study testing Osteopathic manipulative treatment in people with Rett Syndrome, run by Ariel University at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in number of evacuations (time frame: Every day, for one week, immediately before the intervention phase.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05687214, which also lists 69 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.

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