Is Reflexology Applied to Children With Cerebral Palsy an Effective Method?

Cerebral Palsy Clinical Trial

Official title:

Is Reflexology Applied to Children With Cerebral Palsy an Effective Method?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04351464
• Other study ID #: SBEZGIN
• Status: Completed
• Phase: N/A
• Start date: January 1, 2014
• Est. completion date: January 1, 2015

Study information

• Verified date: April 2020
• Source: Kirikkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objectives: This study was planned to investigate the influence of reflexology applied to children with cerebral palsy together with physical therapy program involving neurodevelopmental approaches.

Methods: The study involved 40 children aged,16 girls and 24 boys between 3 and 15 years and divided into two groups. While the children in Group 1 were given twice a week for eight weeks neurodevelopmental treatment, reflexology was applied to those in Group 2 together with neurodevelopmental treatment. Drooling Severity and Frequency Scale, Pediatric Sleep Questionnaire and the Children's Health Questionnaire was used to assess the drooling, status of sleep and quality of life in children.

Description:

The study involved a total of 40 children aged between three and 15 diagnosed with CP by a pediatric neurologist. Children at levels 3/4/5 of the GMFCS who did not have any open wounds on the foot, where the application was to be performed, and whose parents consented to the child's participation were accepted in the study. However, those children were excluded who were treated with botulinum toxin in the last six months, underwent surgery, were treated with reflexology or any other alternative medicine method and who had refractory epilepsy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 1, 2015
• Est. primary completion date: January 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 15 Years

Eligibility

Inclusion Criteria:

• Children at levels 3/4/5 of the GMFCS who did not have any open wounds on the foot, where the application was to be performed, and whose parents consented to the child's participation were accepted in the study.

Exclusion Criteria:

• who were treated with botulinum toxin in the last six months, underwent surgery, were treated with reflexology or any other alternative medicine method and who had refractory epilepsy.

Related Conditions & MeSH terms

• Cerebral Palsy
• Reflexology

Intervention

Other:
• physical therapy and reflexology

Locations

Country	Name	City	State
Turkey	Sabiha Bezgin	Kirikkale

Sponsors (1)

Lead Sponsor	Collaborator
Kirikkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	physiological parameter	Drooling frequency and severity of drooling	8 weeks
Primary	Questionnaire about Sleep status	Assess the problems related to sleep	8 weeks
Primary	Questionnaire about Quality of life of children	general health, physical condition, global behavior, mental health, self-esteem and the effect of time on parents	8 weeks
Secondary	Physical parameter	weight and height will be combined to report BMI in kg/m^2	8 weeks