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

Primary Purpose

Cerebral Palsy, Reflexology

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
physical therapy and reflexology
Sponsored by
Kırıkkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

3 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sabiha Bezgin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Physical therapy and Reflexology group

Just Physical therapy group

Arm Description

Received reflexology implementation for 20-30 minutes on the sole along with the physical treatment involving NDT approaches. Within the scope of the implementation, all the reflex points on the sole were stimulated. The pituitary gland, which is related to sleep and control of salivation, oromotor area and areas of muscular and skeletal system were stimulated with further repetitions.

The group received a 45-minute physical therapy program involving NDT approaches as the control group. Within the scope of this program, the children were treated with intramuscular stretching and soft tissue mobilization, exercises that improved balance and that supported the development of postural control, position shifts, and stretching and reinforcement exercises in the necessary muscle groups.

Outcomes

Primary Outcome Measures

physiological parameter
Drooling frequency and severity of drooling
Questionnaire about Sleep status
Assess the problems related to sleep
Questionnaire about Quality of life of children
general health, physical condition, global behavior, mental health, self-esteem and the effect of time on parents

Secondary Outcome Measures

Physical parameter
weight and height will be combined to report BMI in kg/m^2

Full Information

First Posted
April 10, 2020
Last Updated
April 15, 2020
Sponsor
Kırıkkale University
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1. Study Identification

Unique Protocol Identification Number
NCT04351464
Brief Title
Is Reflexology Applied to Children With Cerebral Palsy an Effective Method?
Official Title
Is Reflexology Applied to Children With Cerebral Palsy an Effective Method?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2014 (Actual)
Primary Completion Date
January 1, 2015 (Actual)
Study Completion Date
January 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kırıkkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Reflexology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical therapy and Reflexology group
Arm Type
Active Comparator
Arm Description
Received reflexology implementation for 20-30 minutes on the sole along with the physical treatment involving NDT approaches. Within the scope of the implementation, all the reflex points on the sole were stimulated. The pituitary gland, which is related to sleep and control of salivation, oromotor area and areas of muscular and skeletal system were stimulated with further repetitions.
Arm Title
Just Physical therapy group
Arm Type
Experimental
Arm Description
The group received a 45-minute physical therapy program involving NDT approaches as the control group. Within the scope of this program, the children were treated with intramuscular stretching and soft tissue mobilization, exercises that improved balance and that supported the development of postural control, position shifts, and stretching and reinforcement exercises in the necessary muscle groups.
Intervention Type
Other
Intervention Name(s)
physical therapy and reflexology
Primary Outcome Measure Information:
Title
physiological parameter
Description
Drooling frequency and severity of drooling
Time Frame
8 weeks
Title
Questionnaire about Sleep status
Description
Assess the problems related to sleep
Time Frame
8 weeks
Title
Questionnaire about Quality of life of children
Description
general health, physical condition, global behavior, mental health, self-esteem and the effect of time on parents
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Physical parameter
Description
weight and height will be combined to report BMI in kg/m^2
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Sabiha Bezgin
City
Kırıkkale
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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