The Efficacy of Massage and Reflexology Applications in Children With Cerebral Palsy

NCT ID: NCT05202028

Last Updated: 2022-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-05

Study Completion Date

2022-08-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Cerebral Palsy Chronic Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Classic abdominal massge

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.

Group Type EXPERIMENTAL

Classic abdominal massage

Intervention Type OTHER

After the physical therapy applied to the patient by the physiotherapist in the special education center for 8 weeks, 3 days a week for about 15-20 minutes. reflexology will be practiced. To families; Training will be given on sleep hygiene, nutritional recommendations and lifestyle changes.

Connective tissue massage

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. Connective tissue massage will be applied. To families; Training will be given on sleep hygiene, nutritional recommendations and lifestyle changes.

Group Type EXPERIMENTAL

Connective Tissue Massage

Intervention Type OTHER

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. Connective tissue massage will be applied. To families; Training will be given on sleep hygiene, nutritional recommendations and lifestyle changes.

Reflexology

After the physical therapy applied to the patient by the physiotherapist in the special education center for 8 weeks, 3 days a week for about 15-20 minutes. reflexology will be practiced. To families; Training will be given on sleep hygiene, nutritional recommendations and lifestyle changes.

Group Type EXPERIMENTAL

Reflexology

Intervention Type OTHER

After the physical therapy applied to the patient by the physiotherapist in the special education center for 8 weeks, 3 days a week for about 15-20 minutes. reflexology will be practiced. To families; Training will be given on sleep hygiene, nutritional recommendations and lifestyle changes.

Interventions

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Reflexology

After the physical therapy applied to the patient by the physiotherapist in the special education center for 8 weeks, 3 days a week for about 15-20 minutes. reflexology will be practiced. To families; Training will be given on sleep hygiene, nutritional recommendations and lifestyle changes.

Intervention Type OTHER

Connective Tissue Massage

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. Connective tissue massage will be applied. To families; Training will be given on sleep hygiene, nutritional recommendations and lifestyle changes.

Intervention Type OTHER

Classic abdominal massage

After the physical therapy applied to the patient by the physiotherapist in the special education center for 8 weeks, 3 days a week for about 15-20 minutes. reflexology will be practiced. To families; Training will be given on sleep hygiene, nutritional recommendations and lifestyle changes.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Halic University

OTHER

Sponsor Role lead

Responsible Party

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Elif İrem Günaydın

PT, MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elif İrem Günaydın, PT, MSc

Role: PRINCIPAL_INVESTIGATOR

Halic University

Locations

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Halic University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 28779938 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24411158 (View on PubMed)

Other Identifiers

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2021/015

Identifier Type: -

Identifier Source: org_study_id

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