Is Reflexology Applied to Children With Cerebral Palsy an Effective Method?
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 10, 2020
CompletedFirst Posted
Study publicly available on registry
April 17, 2020
CompletedApril 17, 2020
April 1, 2020
1 year
April 10, 2020
April 15, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
physiological parameter
Drooling frequency and severity of drooling
8 weeks
Questionnaire about Sleep status
Assess the problems related to sleep
8 weeks
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 Outcomes (1)
Physical parameter
8 weeks
Study Arms (2)
Physical therapy and Reflexology group
ACTIVE COMPARATORReceived 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.
Just Physical therapy group
EXPERIMENTALThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sabiha Bezgin
Kırıkkale, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, Physical Therapist
Study Record Dates
First Submitted
April 10, 2020
First Posted
April 17, 2020
Study Start
January 1, 2014
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
April 17, 2020
Record last verified: 2020-04