An interventional study of Conventional Exercises and Sensory Integration Therapy in Cerebral Palsy, sponsored by Kirsehir Ahi Evran Universitesi. Completed at 1 site in Turkey (Türkiye). Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-07-28.
Sponsored by Kirsehir Ahi Evran Universitesi · Not applicable, Interventional, and Treatment
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
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:
1,891 studies on the registry are indexed under Cerebral Palsy; 439 are open to participants now.
This study's enrollment of 24 is below the median of 34 across 1,396 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Kirsehir Ahi Evran Universitesi is the lead sponsor of 136 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Conventional Exercises
Other: Conventional Exercises
Conventional Exercises + Sensory Integration Therapy
Other: Conventional Exercises · Other: Sensory Integration Therapy
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.
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.
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)
Time frame: 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)
Time frame: 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. )
Time frame: 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.)
Time frame: 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".)
Time frame: 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".)
Time frame: 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)
Time frame: 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)
Time frame: 8 week
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)
Time frame: 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)
Time frame: 8 week
Plan to share: No
Ran from Jan 2018 to primary completion in May 2018, 4 months.
Of 882 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's 4 months is below that.
Counting every sponsor, half of 900 studies reached it within 12 months; a quarter within 5 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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