Osteopathic Manipulative Treatment for Constipation in People With Rett Syndrome
NCT05687214 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2023-02-01
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
More Related Trials
-
Clinical Implementation of a Pictographic Constipation Action Plan for Children With Functional Constipation
NCT05437523 ·Status: COMPLETED ·Phase: NA
-
Adherence and Outcomes in Functional Constipation With a Constipation Action Plan
NCT04614935 ·Status: COMPLETED ·Phase: NA
-
Nutritional Aspects of Rett Syndrome
NCT00004656 ·Status: COMPLETED ·Phase: NA
-
MSOT and MRI for Non-invasive Assessment of Intestinal Transit Time in Children With Chronic Bowel Emptying Disorders
NCT06911749 ·Status: RECRUITING ·Phase: NA
-
Anal Dilatation for Infants and Children With Constipation
NCT02255747 ·Status: UNKNOWN ·Phase: NA
-
Co-Development and Validation of Colonic Symptom Pictograms for Young People
NCT07337343 ·Status: NOT_YET_RECRUITING
-
Open-Label Extension Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome
NCT04279314 ·Status: COMPLETED ·Phase: PHASE3
-
The Role of Dietary Calcium for the Treatment of Osteopenia in Girls With Rett Syndrome
NCT05352373 ·Status: COMPLETED ·Phase: NA
-
Pilot Study of the Effects of the Desipramine on the Neurovegetative Parameters of the Child With Rett Syndrome
NCT00990691 ·Status: COMPLETED ·Phase: PHASE2
-
Diagnosis of Functional Defecation Disorders in Childhood
NCT00230360 ·Status: COMPLETED
-
Methylnaltrexone Use for Opioid-induced Postoperative Constipation
NCT01773096 ·Status: COMPLETED ·Phase: PHASE4
-
Metabolic Evaluation of Nutrition in Rett Syndrome
NCT00786071 ·Status: COMPLETED
-
Impact of Visceral Osteopathic Treatment on Meconium Evacuation in Preterm Infants
NCT02140710 ·Status: COMPLETED ·Phase: PHASE4
-
Hypnosis for Children Undergoing Anorectal Manometry
NCT04471857 ·Status: TERMINATED ·Phase: NA
-
Outpatient Treatment of Constipation in Children
NCT01582659 ·Status: COMPLETED ·Phase: NA
-
Effects of Creatine Supplementation in Rett Syndrome
NCT01147575 ·Status: COMPLETED ·Phase: NA
-
Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth Restriction
NCT05651347 ·Status: RECRUITING ·Phase: PHASE3
-
Predictors of Constipation in Healthy Children
NCT00398021 ·Status: COMPLETED
-
Independent Studies of Dextromethorphan and of Donepezil Hydrochloride for Rett Syndrome
NCT00069550 ·Status: UNKNOWN ·Phase: PHASE3
-
Recurrent Abdominal Pain in Children
NCT00526903 ·Status: COMPLETED ·Phase: PHASE2
-
Massage With Senna-based Laxatives Versus Senna-based Laxatives in Managing Overflow Retentive Stool Incontinence
NCT04273295 ·Status: COMPLETED ·Phase: NA
-
The Diagnostic Experience of Male Rett Syndrome
NCT06346106 ·Status: RECRUITING
-
The Effects of Enzyme-rich Malt Extract on Chronic Constipation
NCT04873466 ·Status: COMPLETED ·Phase: NA
-
Development of an Instrument to Measure Quality of Life in Children With Chronic Constipation and Soiling
NCT00677508 ·Status: COMPLETED
-
Efficacy of Chinese Herbal Medicine Xiaojidaozhi Decoction in the Treatment of Childhood Constipation
NCT03186079 ·Status: COMPLETED ·Phase: EARLY_PHASE1