NCT04802551

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 10, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 14, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 17, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2021

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

March 14, 2021

Last Update Submit

March 14, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Upper extremity functions

    It will be measured via Quality of Upper Extremity Skills Test

    8 weeks

  • Trunk Control

    It will be measured via Trunk Control Measurement Scale

    8 weeks

  • Balance

    It will be measured via Pediatric Balance Scale

    8 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL
Other: Sensory integration therapy

Control group

NO INTERVENTION

Interventions

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.

Intervention group

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Being in the age range of 0-18
  • Being diagnosed with cerebral palsy
  • Consent to participate in the study by the parents

You may not qualify if:

  • Having received botulinum toxin injection in the last 6 months
  • Having musculoskaletal surgery in the last 6 months
  • Having severe mental retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Bakircay University

Izmir, 35665, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Gulbin ERGIN, Assoc. Prof

    Izmir Bakircay University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hilal AKTAS

Study Record Dates

First Submitted

March 14, 2021

First Posted

March 17, 2021

Study Start

February 10, 2021

Primary Completion

June 15, 2021

Study Completion

August 15, 2021

Last Updated

March 17, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations