The Effect of Sensory Integration Therapy on Upper Extremity Functions, Trunk Control and Balance in Children With Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Sensory integration therapy
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy
Eligibility Criteria
Inclusion Criteria:
- Being in the age range of 0-18
- Being diagnosed with cerebral palsy
- Consent to participate in the study by the parents
Exclusion Criteria:
- Having received botulinum toxin injection in the last 6 months
- Having musculoskaletal surgery in the last 6 months
- Having severe mental retardation
Sites / Locations
- Izmir Bakircay UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Outcomes
Primary Outcome Measures
Upper extremity functions
It will be measured via Quality of Upper Extremity Skills Test
Trunk Control
It will be measured via Trunk Control Measurement Scale
Balance
It will be measured via Pediatric Balance Scale
Secondary Outcome Measures
Full Information
NCT ID
NCT04802551
First Posted
March 14, 2021
Last Updated
March 14, 2021
Sponsor
Izmir Bakircay University
1. Study Identification
Unique Protocol Identification Number
NCT04802551
Brief Title
The Effect of Sensory Integration Therapy on Upper Extremity Functions, Trunk Control and Balance in Children With Cerebral Palsy
Official Title
The Effect of Sensory Integration Therapy on Upper Extremity Functions, Trunk Control and Balance in Children With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 10, 2021 (Actual)
Primary Completion Date
June 15, 2021 (Anticipated)
Study Completion Date
August 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Bakircay 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
In children with cerebral palsy, the interactions of the sensory systems, musculoskaletal system and central nervous system are damaged. This situation plays an important role in the realization of trunk control and upper extremity functions.When we look at the literature, it was seen that upper extremity functions were associated with trunk control and oscillation, and it was observed that upper extremity functions were improved in cases with increased trunk control and balance.In the studies, it was concluded that increasing the trunk control improves the static and dynamic balance.Ayres introduced the theory of sensory integrity in the 1970s and defined sensory integration as "the neurological process that organizes the senses coming from the person's body and the environment and makes it possible to use the body effectively in the environment".Sensory integration disorder is defined as the inability of a person to use the information he / she receives through his / her senses properly in order to continue his daily life properly.The incidence of sensory integration disorder in children with motor dysfunction such as cerebral palsy and central nervous system involvement is between 40 and 80%.In children with cerebral palsy, due to central nervous system damage, posture problems, lack of movement and functional deficiencies, sensory problems that can cause balance losses can be seen. When we look at the literature, it has been seen that there are studies on balance, trunk control and upper extremity functions in children with cerebral palsy, but among these studies, the inadequacy of studies that associate balance disorders and trunk control with sensory integration therapy was observed.In this study, the effects of sensory integration therapy on balance, trunk control and upper extremity functions in children with cerebral palsy will be investigated.Pediatric Balance Scale, Trunk Control Measurement Scale, Upper Extremity Skill Quality Scale will be used for balance assessment of individuals with cerebral palsy participating in the study.The study was planned as a single blind randomized control.Participants will be randomly divided into two groups, the control group will be given balance exercises that are included in the standard physiotherapy program, and the experimental group will be given sensory integration exercises for the vestibular system in addition to standard physiotherapy programs.The treatment program to be applied to both experimental and control groups will be carried out by a physiotherapist who has 7 years of experience in pediatric physiotherapy and has 6 years of active sensory integration therapy.Evaluations will be evaluated 3 times by a blinded physiotherapist experienced in the field of pediatrics before, after treatment and 8 weeks after the late period effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Sensory integration therapy
Intervention Description
Sensory integration disorder is defined as the inability of a person to use the information he / she receives through his / her senses properly in order to continue his daily life properly. Intervention group have some therapy sessions which include sensory integration therapy exercises.
Primary Outcome Measure Information:
Title
Upper extremity functions
Description
It will be measured via Quality of Upper Extremity Skills Test
Time Frame
8 weeks
Title
Trunk Control
Description
It will be measured via Trunk Control Measurement Scale
Time Frame
8 weeks
Title
Balance
Description
It will be measured via Pediatric Balance Scale
Time Frame
8 weeks
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Being in the age range of 0-18
Being diagnosed with cerebral palsy
Consent to participate in the study by the parents
Exclusion Criteria:
Having received botulinum toxin injection in the last 6 months
Having musculoskaletal surgery in the last 6 months
Having severe mental retardation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hilal AKTAS
Phone
+905545747394
Email
hilalakmese@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gulbin ERGIN, Assoc. Prof
Organizational Affiliation
Izmir Bakircay University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Izmir Bakircay University
City
İzmir
ZIP/Postal Code
35665
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hilal AKTAS
Phone
05545747394
Email
hilalakmese@gmail.com
First Name & Middle Initial & Last Name & Degree
Gulbin ERGIN
First Name & Middle Initial & Last Name & Degree
Gozde KAYA
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Sensory Integration Therapy on Upper Extremity Functions, Trunk Control and Balance in Children With Cerebral Palsy
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