Cerebral PalsyNCT04802551
The Effect of Sensory Integration Therapy on Upper Extremity Functions, Trunk Control and Balance in Children With Cerebral Palsy
A study testing Sensory integration therapy in people with Cerebral Palsy, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Sensory integration therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2021to 15 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Being in the age range of 0-18
- Being diagnosed with cerebral palsy
- Consent to participate in the study by the parents
Who cannot join
- Having received botulinum toxin injection in the last 6 months
- Having musculoskaletal surgery in the last 6 months
- Having severe mental retardation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Izmir Bakircay University
Izmir, 35665
Hilal AKTAS, 05545747394, hilalakmese@gmail.com
Gulbin ERGIN
About this study
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.
- Conditions
- Cerebral Palsy
- Being tested
- Sensory integration therapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory integration therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Other: Sensory integration therapy |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper extremity functions
It will be measured via Quality of Upper Extremity Skills Test
Measured: 8 weeks
Trunk Control
It will be measured via Trunk Control Measurement Scale
Measured: 8 weeks
Balance
It will be measured via Pediatric Balance Scale
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start10 Feb 2021
- Primary completion15 Jun 2021 (estimated)
- Study completion15 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal AKTAS, Izmir Bakircay University
- Investigators
- Gulbin ERGIN, Assoc. Prof, Principal investigator, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802551
- Sponsor's protocol ID
- Izmir Bakircay University
- Status last verified
- Mar 2021
- First submitted
- 14 Mar 2021
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sensory Integration Therapy on Upper Extremity Functions, Trunk Control and Balance in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04802551
- Acronym / sponsor ID
- Izmir Bakircay University
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 15 Jun 2021 (estimated)
- Study completion
- 15 Aug 2021 (estimated)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Sensory integration therapy |
| Control group | No intervention | – |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Being in the age range of 0-18
- Being diagnosed with cerebral palsy
- Consent to participate in the study by the parents
Key exclusion criteria (3 listed)
- Having received botulinum toxin injection in the last 6 months
- Having musculoskaletal surgery in the last 6 months
- Having severe mental retardation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory integration therapySensory 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. | Other | Intervention group |
Primary outcome
Upper extremity functions
Time frame: 8 weeks
It will be measured via Quality of Upper Extremity Skills Test
Trunk Control
Time frame: 8 weeks
It will be measured via Trunk Control Measurement Scale
Balance
Time frame: 8 weeks
It will be measured via Pediatric Balance Scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gulbin ERGIN, Assoc. Prof principal investigator
Izmir Bakircay University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory integration therapy in people with Cerebral Palsy, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hilal AKTAS (+905545747394, hilalakmese@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper extremity functions (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.