Cerebral PalsyNCT05966428
Sensory Integration Therapy and Cerebral Palsy
A study testing Conventional Exercises and Sensory Integration Therapy in people with Cerebral Palsy, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This intervention study was planned to investigate the effects of Sensory Integration Therapy that added to the conventional therapy program on spasticity, balance, motor function and functional independency levels of children with spastic diplegic cerebral palsy Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Conventional Exercises and Sensory Integration Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 1 Jun 2018
- 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Between the ages of 4-17
- Diagnosed with spastic diplegic type Cerebral Palsy
- Having Gross Motor Function Classification System levels I and II
Who cannot join
- Children who underwent phenol and botulinum toxin-a injections in the last 6 months before the study
- Had a previous surgical operation, and had a cardiopulmonary disease that could prevent exercise
- Children with communication, hearing and vision problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Affect of Sensory Integration Therapy and Conventional Exercise Therapy on Spasticity, Balance and Motor Function With Spastic Diplegic Cerebral Palsy
This intervention study was planned to investigate the effects of Sensory Integration Therapy that added to the conventional therapy program on spasticity, balance, motor function and functional independency levels of children with spastic diplegic cerebral palsy
Read the detailed description
Cerebral Palsy is a disease that can cause motor skill and posture disorders due to a non-progressive lesion in the brain that has not yet completed its development. Cerebral palsy is among the most common causes of disability in childhood. There are many conditions that can cause Cerebral Palsy. Risk groups that cause brain damage can be considered as prenatal, perinatal and postnatal risk factors.The lesion that occurs in the central nervous system in patients with Cerebral Palsy causes some problems in the musculoskeletal system, nervous system and sensory systems. In addition to these problems, depending on the level of the lesion, posture, movement disorders and balance problems occur in individuals with Cerebral Palsy. Sensory integration therapy is a neurological process of perceiving, interpreting and organizing our senses for an effective integration of the individual with the environment. When the literature is examined, the number of studies investigating the effect of sensory integration program in children with spastic diplegic type Cerebral Palsy is insufficient. The aim of this study is to investigate the effect of sensory integration therapy on spasticity, balance and motor function in children with spastic diplegic type Cerebral Palsy and to provide the data obtained at the end of the study to the literature both theoretically and practically.
The hypothesis of the study is:
- Sensory integration program reduces spasticity in children with spastic diplegic type Cerebral Palsy.
- Sensory integration program increases balance in children with spastic diplegic type Cerebral Palsy.
- Sensory integration program increases motor function in children with spastic diplegic type Cerebral Palsy.
- Conditions
- Cerebral Palsy
- Being tested
- Conventional Exercises, Sensory Integration Therapy
- Keywords
- Sensory Integration, Physical Therapy and Rehabilitation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional ExercisesOther
This conventional exercises included stretching and strengthening, balance-coordination, mobility and range of motion exercises.
The control group received conventional therapy 3 days a week for 8 weeks. Each therapy session a day lasted 45 minutes in control group.
Sensory Integration TherapyOther
The Sensory Integration Therapy was applied to the intervention group in addition to the conventional exercise program. Sensory Integration Therapy included tactile, proprioceptive, and vestibular activities. The tactile sensory activities consisted of materials such as stepping stones, tactile box, brushing, fabric walking path. The vestibular sensory activities consisted of materials such as hammock swings, trampolines, rope nets, rock walls, river stones. Proprioceptive sensory activities consisted of materials such as weight bearing activities, heavy lifting, deep pressure, big ball activities, tug of war and ball pits.
The intervention group underwent each session 45 minute conventional therapy and 15 minutes SIT. The therapy program continued 3 days a week for 8 weeks in intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Conventional Exercises Receives: Other: Conventional Exercises |
| Intervention Group | Experimental | Conventional Exercises + Sensory Integration Therapy Receives: Other: Conventional Exercises; Other: Sensory Integration Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Tone
Modified Ashworth Scale (The muscle tone evaluated on this scale is graded between 0 and 4 and is scored between 0 and 5)
Measured: A day before the rehabilitation
Muscle Tone
Modified Ashworth Scale (The muscle tone evaluated on this scale is graded between 0 and 4 and is scored between 0 and 5)
Measured: 8 week
Functional Balance
Pediatric Berg Balance Scale (The scale consists of 14 section. Each section is scored from 0 lowest function to 4 highest function. )
Measured: A day before the rehabilitation
Functional Balance
Pediatric Berg Balance Scale (The scale consists of 14 section. Each section is scored from 0 lowest function to 4 highest function.)
Measured: 8 week
Gross Motor Function
Gross Motor Function Measure (The scores are in 4 categories as "0" not starting the activity, starting independently "1", partially completing "2" and independently completing "3".)
Measured: A day before the rehabilitation
Gross Motor Function
Gross Motor Function Measure (The scores are in 4 categories as "0" not starting the activity, starting independently "1", partially completing "2" and independently completing "3".)
Measured: 8 week
Functional Independence
Functional Independence Measure for Children (These items are scored from 1 to 7 according to whether they received help while performing each function)
Measured: A day before the rehabilitation
Functional Independence
Functional Independence Measure for Children (These items are scored from 1 to 7 according to whether they received help while performing each function)
Measured: 8 week
Secondary outcomes (2)
Gross Motor Function Classification
Gross Motor Function Classification System (Children with Cerebral Palsy are classified in 5 levels (1-5) according to their motor skills, functional abilities, assistive technology and wheelchair requirements)
Measured: A day before the rehabilitation
Gross Motor Function Classification
Gross Motor Function Classification System (Children with Cerebral Palsy are classified in 5 levels (1-5) according to their motor skills, functional abilities, assistive technology and wheelchair requirements)
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start1 Jan 2018
- Primary completion1 May 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study consisted of 2 groups as control and experiment.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atahan TURHAN, Kirsehir Ahi Evran Universitesi
- Investigators
- Atahan TURHAN, PhD, Principal investigator, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966428
- Sponsor's protocol ID
- KAEU-T.ATAHAN-001
- Status last verified
- Jul 2023
- First submitted
- 13 Jul 2023
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kantor J, Hlavackova L, Du J, Dvorakova P, Svobodova Z, Karasova K, Kantorova L. The Effects of Ayres Sensory Integration and Related Sensory Based Interventions in Children with Cerebral Palsy: A Scoping Review. Children (Basel). 2022 Apr 1;9(4):483. doi: 10.3390/children9040483.
PubMed 35455527Warutkar VB, Krishna Kovela R. Review of Sensory Integration Therapy for Children With Cerebral Palsy. Cureus. 2022 Oct 26;14(10):e30714. doi: 10.7759/cureus.30714. eCollection 2022 Oct.
PubMed 36439588
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Affect of Sensory Integration Therapy and Conventional Exercise Therapy on Spasticity, Balance and Motor Function With Spastic Diplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05966428
- Acronym / sponsor ID
- KAEU-T.ATAHAN-001
- Conditions
- Cerebral Palsy
- Keywords
- Sensory Integration, Physical Therapy and Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 28 Jul 2023 (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.
This intervention study was planned to investigate the effects of Sensory Integration Therapy that added to the conventional therapy program on spasticity, balance, motor function and functional independency levels of children with spastic diplegic cerebral palsy
Detailed description
Cerebral Palsy is a disease that can cause motor skill and posture disorders due to a non-progressive lesion in the brain that has not yet completed its development. Cerebral palsy is among the most common causes of disability in childhood. There are many conditions that can cause Cerebral Palsy. Risk groups that cause brain damage can be considered as prenatal, perinatal and postnatal risk factors.The lesion that occurs in the central nervous system in patients with Cerebral Palsy causes some problems in the musculoskeletal system, nervous system and sensory systems. In addition to these problems, depending on the level of the lesion, posture, movement disorders and balance problems occur in individuals with Cerebral Palsy. Sensory integration therapy is a neurological process of perceiving, interpreting and organizing our senses for an effective integration of the individual with the environment. When the literature is examined, the number of studies investigating the effect of sensory integration program in children with spastic diplegic type Cerebral Palsy is insufficient. The aim of this study is to investigate the effect of sensory integration therapy on spasticity, balance and motor function in children with spastic diplegic type Cerebral Palsy and to provide the data obtained at the end of the study to the literature both theoretically and practically.
The hypothesis of the study is:
- Sensory integration program reduces spasticity in children with spastic diplegic type Cerebral Palsy.
- Sensory integration program increases balance in children with spastic diplegic type Cerebral Palsy.
- Sensory integration program increases motor function in children with spastic diplegic type Cerebral Palsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study consisted of 2 groups as control and experiment.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Conventional ExercisesConventional Exercises |
| Intervention Group | Experimental | Other: Conventional Exercises, Other: Sensory Integration TherapyConventional Exercises + Sensory Integration Therapy |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Between the ages of 4-17
- Diagnosed with spastic diplegic type Cerebral Palsy
- Having Gross Motor Function Classification System levels I and II
Key exclusion criteria (3 listed)
- Children who underwent phenol and botulinum toxin-a injections in the last 6 months before the study
- Had a previous surgical operation, and had a cardiopulmonary disease that could prevent exercise
- Children with communication, hearing and vision problems
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 |
|---|---|---|
| Conventional ExercisesThis conventional exercises included stretching and strengthening, balance-coordination, mobility and range of motion exercises. The control group received conventional therapy 3 days a week for 8 weeks. Each therapy session a day lasted 45 minutes in control group. | Other | Control Group, Intervention Group |
| Sensory Integration TherapyThe Sensory Integration Therapy was applied to the intervention group in addition to the conventional exercise program. Sensory Integration Therapy included tactile, proprioceptive, and vestibular activities. The tactile sensory activities consisted of materials such as stepping stones, tactile box, brushing, fabric walking path. The vestibular sensory activities consisted of materials such as hammock swings, trampolines, rope nets, rock walls, river stones. Proprioceptive sensory activities consisted of materials such as weight bearing activities, heavy lifting, deep pressure, big ball activities, tug of war and ball pits. The intervention group underwent each session 45 minute conventional therapy and 15 minutes SIT. The therapy program continued 3 days a week for 8 weeks in intervention group. | Other | Intervention Group |
Primary outcome
Muscle Tone
Time frame: A day before the rehabilitation
Modified Ashworth Scale (The muscle tone evaluated on this scale is graded between 0 and 4 and is scored between 0 and 5)
Muscle Tone
Time frame: 8 week
Modified Ashworth Scale (The muscle tone evaluated on this scale is graded between 0 and 4 and is scored between 0 and 5)
Functional Balance
Time frame: A day before the rehabilitation
Pediatric Berg Balance Scale (The scale consists of 14 section. Each section is scored from 0 lowest function to 4 highest function. )
Functional Balance
Time frame: 8 week
Pediatric Berg Balance Scale (The scale consists of 14 section. Each section is scored from 0 lowest function to 4 highest function.)
Gross Motor Function
Time frame: A day before the rehabilitation
Gross Motor Function Measure (The scores are in 4 categories as "0" not starting the activity, starting independently "1", partially completing "2" and independently completing "3".)
Gross Motor Function
Time frame: 8 week
Gross Motor Function Measure (The scores are in 4 categories as "0" not starting the activity, starting independently "1", partially completing "2" and independently completing "3".)
Functional Independence
Time frame: A day before the rehabilitation
Functional Independence Measure for Children (These items are scored from 1 to 7 according to whether they received help while performing each function)
Functional Independence
Time frame: 8 week
Functional Independence Measure for Children (These items are scored from 1 to 7 according to whether they received help while performing each function)
2 secondary outcomes
Gross Motor Function Classification
Time frame: A day before the rehabilitation
Gross Motor Function Classification
Time frame: 8 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Results publication: PubMed 35455527Kantor J, Hlavackova L, Du J, Dvorakova P, Svobodova Z, Karasova K, Kantorova L. The Effects of Ayres Sensory Integration and Related Sensory Based Interventions in Children with Cerebral Palsy: A Scoping Review. Children (Basel). 2022 Apr 1;9(4):483. doi: 10.3390/children9040483.
- Results publication: PubMed 36439588Warutkar VB, Krishna Kovela R. Review of Sensory Integration Therapy for Children With Cerebral Palsy. Cureus. 2022 Oct 26;14(10):e30714. doi: 10.7759/cureus.30714. eCollection 2022 Oct.
- 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.
Atahan TURHAN, PhD principal investigator
Kirsehir Ahi Evran Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Exercises and Sensory Integration Therapy in people with Cerebral Palsy, run by Kirsehir Ahi Evran Universitesi 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: finished, as of the sponsor's last update on 28 Jul 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Tone (time frame: A day before the rehabilitation). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05966428, which also lists 2 linked publications.
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 28 Jul 2023.