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

Sponsor
Kırıkkale University (Other)
Overall Status
Completed
CT.gov ID
NCT04351464
Collaborator
(none)
40
1
2
12
3.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: physical therapy and reflexology
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Is Reflexology Applied to Children With Cerebral Palsy an Effective Method?
Actual Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Jan 1, 2015
Actual Study Completion Date :
Jan 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Physical therapy and Reflexology group

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.

Other: physical therapy and reflexology

Experimental: Just Physical therapy group

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.

Other: physical therapy and reflexology

Outcome Measures

Primary Outcome Measures

  1. physiological parameter [8 weeks]

    Drooling frequency and severity of drooling

  2. Questionnaire about Sleep status [8 weeks]

    Assess the problems related to sleep

  3. Questionnaire about Quality of life of children [8 weeks]

    general health, physical condition, global behavior, mental health, self-esteem and the effect of time on parents

Secondary Outcome Measures

  1. Physical parameter [8 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 15 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sabiha Bezgin Kırıkkale Turkey

Sponsors and Collaborators

  • Kırıkkale University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sabiha BEZGİN, PhD, Physical Therapist, Kırıkkale University
ClinicalTrials.gov Identifier:
NCT04351464
Other Study ID Numbers:
  • SBEZGIN
First Posted:
Apr 17, 2020
Last Update Posted:
Apr 17, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 17, 2020