Clinical trial NCT05202028: The Efficacy of Massage and Reflexology Applications in Children With Cerebral Palsy
Official title: Comparison of the Efficacy of Abdominal Massage, Connective Tissue Massage and Reflexology Applications on Constipation and Sleep Quality in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Chronic Constipation
Keywords: Cerebral Palsy
Chronic constipation
sleep quality
Lead sponsor: Halic University
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to compare the effectiveness of classical massage, connective tissue massage, and reflexology in children with cerebral palsy.

Detailed description: The universe of the study will consist of children aged 4-18 years with a diagnosis of CP and chronic constipation who were admitted to the Duha Special Education and Rehabilitation Center. As a result of the power analysis, the minimum number of participants was determined as 20 for each group. Measurement and evaluation will be made to the groups three times, before the study, after the study (8th week), and follow-up at the 12th week.

Evaluations will be made by another physiotherapist who has no knowledge of the research topic and research groups. Children participating in the study will be determined by randomization using the closed-envelope method. The study is a randomized controlled experimental study.

In the study, the effects of treatments on the level of constipation, participation inactivity, and patient-parent sleep quality will be questioned. The sociodemographic data of the participants will be recorded in the general evaluation form. Gross Motor Function Classification System (KMFSS) to classify motor function levels, Gross Motor Function Scale-88 (KMFF-88) to assess functional status, and Functional Independence Measure= FIM to assess spasticity, Modified Ashworth Scale to assess constipation, Bristol for constipation assessment The Poo Scale and Constipation Severity Scale (BSS), and the Child Sleep Form (CUF) and the Pittsburgh Sleep Quality Index (PUKI) will be used for sleep assessment.

1. Group - Classical Abdominal Massage Group: After the physical therapy applied to the patient by the physiotherapist in the special education center, 3 days a week for 8 weeks, once a day for approximately 15-20 minutes. Classic abdominal massage will be applied. To families; Training will be given on sleep hygiene, nutritional recommendations, and lifestyle changes.
2. Group- Connective Tissue Massage Group: After the physical therapy applied to the patient by the physiotherapist in the special education center for 8 weeks, 3 days a week, once a day for approximately 15-20 minutes. Connective tissue massage will be applied. To families; Training will be given on sleep hygiene, nutritional recommendations, and lifestyle changes.
3. Group- Reflexology Group: After the physical therapy applied to the patient by the physiotherapist in the special education center for 8 weeks, 3 days a week for approximately 15-20 minutes. reflexology will be practiced. To families; Training will be given on sleep hygiene, nutritional recommendations, and lifestyle changes.

Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with cerebral palsy
* According to Gross Motor Function Test III, IV. and level V.
* Constipation in the last 6 months
* Age range is 4-18 years old
* Absence of any cardiopulmonary disease that will prevent exercise
* Patients who were informed about the study and whose families gave written consent to participate in the study will be included in the study.

Exclusion Criteria:

* Having undergone surgery involving intestinal health
* Having a chronic infectious bowel disease
* Having a congenital intestinal anomaly
* To have received Botox treatment in the last 6 months
* Absence of constipation in the last 6 months
* Levels I and II according to Gross Motor Function Test
* Having uncontrolled epileptic seizures
* Not signing the voluntary information and consent form
* Not continuing to work regularly

Primary outcomes:
measure: Change from Baseline in Gross Motor Function Measure (GMFM-88) at 8 weeks and 12 weeks
timeFrame: At the beginning of study, 8th week of study and 12th week of study
measure: Change from Baseline in Functional Independence Measure (FIM) at 8 weeks and 12 weeks
timeFrame: At the beginning of study, 8th week of study and 12th week of study
measure: Change from Baseline in Bristolian Scale (BS) at 8 weeks and 12 weeks
timeFrame: At the beginning of study, 8th week of study and 12th week of study
measure: Change from Baseline in Constipation Severity Scale (CSS) at 8 weeks and 12 weeks
timeFrame: At the beginning of study, 8th week of study and 12th week of study
measure: Change from Baseline in Sleep Form in Children (SFC) at 8 weeks and 12 weeks
timeFrame: At the beginning of study, 8th week of study and 12th week of study
measure: Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at 8 weeks and 12 weeks
timeFrame: At the beginning of study, 8th week of study and 12th week of study
Secondary outcomes:
measure: Change from Baseline in Modifiye Ashworth Scale (MAS) at 8 weeks and 12 weeks
timeFrame: At the beginning of study, 8th week of study and 12th week of study
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Halic University
Study officials:
affiliation: Halic University
name: Elif İrem Günaydın, PT, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Esmel-Esmel N, Tomas-Esmel E, Tous-Andreu M, Bove-Ribe A, Jimenez-Herrera M. Reflexology and polysomnography: Changes in cerebral wave activity induced by reflexology promote N1 and N2 sleep stages. Complement Ther Clin Pract. 2017 Aug;28:54-64. doi: 10.1016/j.ctcp.2017.05.003. Epub 2017 May 12.
citation: Holey LA, Dixon J. Connective tissue manipulation: a review of theory and clinical evidence. J Bodyw Mov Ther. 2014 Jan;18(1):112-8. doi: 10.1016/j.jbmt.2013.08.003. Epub 2013 Sep 8.