Cerebral PalsyCPNCT05213715
The Effect Of Somatosensory Perceptıon And Proprıoceptıon On Upper Extremıty Functıonal Skılls
An observational study of Cerebral Palsy and Somatosensory Disorders, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
Cerebral Palsy (CP) is a non-progressive neurodevelopmental disorder characterized by posture and movement disorders as a result of damage to the immature brain for any reason before, during or after birth.In addition to tone, postural and neuromuscular control in children with Cerebral Palsy; Problems are also… Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Somatosensory Disorders, Upper Extremity Dysfunction
- What is being tested?
- assessment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2022to 28 Feb 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: children with cerebral palsy and healty peer aged children
Who may be able to join
- Diagnosed with Hemiparetic and Diparetic CP with Gross Motor Function Classification System (GMFCS) Level ≤ 3
- Children with ≤ 2 upper extremity muscles according to the Modified Ashworth Scale (MAS)
- Children with Manual Skills Classification System (MACS) ≤ 3
- Not being diagnosed with mental disability by the RAM (Guidance Research Center)
- Children with CP aged 6-18 years
- Not receiving surgery or Botox (Botulinum Toxin) treatment in the last 6 months
- Children with CP with parental approval
Who cannot join
- Joint contracture in the shoulder, elbow and hand-wrist
- Having any hearing or vision problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hatice Adıgüzel
Kahramanmaraş, Dulkadiroglu, 46100
About this study
Official title: The Effect Of Somatosensory Perception And Proprioception On Upper Extremity Functional Skills In Children With Hemiparetic And Diparetic Cerebral Palsy
Cerebral Palsy (CP) is a non-progressive neurodevelopmental disorder characterized by posture and movement disorders as a result of damage to the immature brain for any reason before, during or after birth.In addition to tone, postural and neuromuscular control in children with Cerebral Palsy; Problems are also observed in communication skills, perceptual and cognitive systems and sensory systems.
Read the detailed description
In neurodevelopmental theory, sensory and motor systems mutually support the development of each other. In addition to the motor problems observed in SP; Sensory-motor impairment, which occurs with the effects of systems such as proprioception, tactile (touch), and vestibular (balance), emerges as the main problem. With the involvement of the central nervous system (CNS) in CP, the sensory systems are also affected along with the motor systems. The involvement of the sensory system is seen in 45% of these children and presents with a white matter lesion. One of the important factors affecting the activities of daily living (ADL) in children with Cerebral Palsy is the deficiencies in their functions as a result of the affected upper extremity. Deficiencies in sensory input can cause delays in learning new motor movements. This can result in disuse of the extremities and sensitivity. The somatosensory cortex, which is important for sensory integration; It is the area of the brain that is sensitive to tactile sensations from the body. It is known that the somatosensory system, which carries these tactile stimuli to the somatosensory cortex, is active from the early stage of life. Sensory and motor interactions experienced in the early stages of life are important for motor development even in the early stages. The improvement in measurable cortical responses of the tactile system; It starts from the 8th week of intrauterine and continues until the postpartum period. In the newborn period, the infant's responses to tactile and proprioceptive stimuli play an important role in the development of motor, cognitive, social and communication skills during infancy and early childhood. The aim of this study is to investigate the effects of somatosensory perception and proprioception on upper extremity functional skills in children with hemiparetic and diparetic CP.
- Conditions
- Cerebral Palsy, Somatosensory Disorders, Upper Extremity Dysfunction, Proprioceptive Disorders
- Being tested
- assessment
- Medical subject headings
- Cerebral Palsy, Somatosensory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessmentOther
assessment of upper extremity functions, somatosensorial functions and proprioseption of upper extremity
| Study group | Role | What they receive |
|---|---|---|
| 1/Children with diparetic cerebral palsy | 1/Children with diparetic cerebral palsy Receives: Other: assessment | |
| 2/Children with hemiparetic cerebral palsy | 2/Children with hemiparetic cerebral palsy Receives: Other: assessment | |
| 3/healty peer aged children | 3/healty peer aged children Receives: Other: assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
upper extremity proprioseption test
Measurements will be done by a goniometer for bilateral upper extremity shoulder flexion-abduction, elbow flexion-extension, supination-pronation, hand-wrist flexion. The eyes will be closed or the head turned to the opposite direction of the evaluated area. The difference between the value for the full range and the value for the half range will be recorded on the test paper as angular. Higher angular difference indicates worse proprioception.
Measured: first day of assessment
Kinesthesia Test
The difference in the distance between the point where the child ends the movement and the end point of the real line is measured on the evaluation paper with a ruler. The total value of the right and left obtained is recorded by subtracting from 50. The higher the difference, the better the kinesthesia. The test will be applied bilaterally.
Measured: first day of assessment
somatosensory perception of upper extremity (touch stimulus localization test)
Touch stimulus localization test is one of the Ayres' Southern California Sensory Integration and Praxis Test (SIPT) somatosensory perception subtests. Before starting the test, the child is asked to close his eyes. The hand, wrist and forearm are touched once with a pencil in order, first in the pronation position and then in the supination position, and the child is asked to point to the touched area with his finger. The distance between the place touched by the pen and the place indicated by the child is measured with a ruler and recorded on the evaluation sheet in cm. The test is applied bilaterally. Evaluation; The farther the distance between the real touched place and the child touches, the worse tactile perception is interpreted, the closer the real touched place and the child's touched place, the better it is interpreted to show tactile perception.
Measured: first day of assesment
somatosensory perception of upper extremity (double-touch stimulus localization test)
Double-touch stimulus localization test is one of the Ayres' Southern California Sensory Integration and Praxis Test (SIPT) somatosensory perception subtests. Before starting the test, the child is asked to close his eyes. With 2 separate pens, you can simultaneously use two different points such as left hand-right cheek, right hand-left hand, left cheek-right cheek, left hand-left cheek, right hand-left cheek, right hand-right cheek while eyes are closed. tactile. The child is asked to say or show both points touched. If the child knows both points, 2 points, 1 point if he knows one, 0 points if he does not know, and a total score is obtained. In scoring, where the best value is measured out of 14, the lower this value is interpreted as the worse tactile perception, the closer it is to this value, the better tactile perception is interpreted.
Measured: first day of assesment
somatosensory perception of upper extremity (finger recognition test)
Finger recognition test is one of the Ayres' Southern California Sensory Integration and Praxis Test (SIPT) somatosensory perception subtests. Before starting the test, the child is asked to close his eyes. He is asked to put his hands on the table and the child's eyes are closed and 16 different points (8 right hand-8 left hand) are touched with a pencil. They are asked to point to the touched points with their fingers or to express audibly. For each point touched, scoring is done as 1 for a correct answer and 0 for an incorrect answer. The test was performed bilaterally. The patient's total score is obtained by summing the scores for both hands. In this measurement method, which is evaluated out of 16; The closer the value to 16 indicates good tactile perception, while the farther away it is, the worse it indicates tactile perception.
Measured: first day of assesment
somatosensory perception of upper extremity (right-left discrimination test)
Right-left discrimination test is one of the Ayres' Southern California Sensory Integration and Praxis Test (SIPT) somatosensory perception subtests. The child is asked to repeat the same by giving 10 body imitation commands. With the paper with the test questions in the hands of the physiotherapist, the assessment of the child begins. The score for the test is 2 points if he answers correctly in the first three seconds, 1 point if he answers in ten seconds, and 0 points if he fails to answer. The total score is recorded by summing all the sub-scores of the child from the 10 questions in the test.
Measured: first day of assesment
The Jebsen Taylor Hand Function Test (JTHFT)
The Jebsen Taylor Hand Function Test (JTHFT) will be used to assess upper extremity functional skills. JTEFT, which is used in the 6-18 age range, consists of serial subtests representing hand function in daily life. The application of this test, which consists of 6 items, takes 15-45 minutes. A scaled board is used to provide a standard arrangement of objects in the test. The time when all activities are done is recorded with a stopwatch. Higher duration indicates worse hand function.
Measured: first day of assesment
Secondary outcomes (3)
manuel ability classification system (MACS)
It is a classification system created to classify the hand skills of children with CP between the ages of 4-18, such as grasping and releasing objects in daily life, and how they use their hands while holding objects. MACS defines five levels. The higher level indicates worse hand function.
Measured: first day of assessment
Gross Motor Function Classification System(GMFCS)
Gross motor function classification system (GMFCS) is a classification system developed by Palisano et al. in 1997 and expanded in 2007 to classify the gross motor functions of children with CP. Gross motor function in children with CP is a standardized method that classifies motor function differences, especially in sitting and walking, at 5 levels. A higher level indicates worse function.
Measured: first day of assessment
demographic information
demographic information will be recorded (age, gender, height, weight)
Measured: first day of assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start10 Jan 2022
- Primary completion20 Feb 2022
- Study completion28 Feb 2022
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Adiguzel, Kahramanmaras Sutcu Imam University
- Investigators
- hatice adıgüzel, PhD, Study chair, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213715
- Sponsor's protocol ID
- KSUU
- Acronym
- CP
- Status last verified
- Mar 2022
- First submitted
- 15 Jan 2022
- Last updated
- 1 Apr 2022
- 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 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Somatosensory Perception And Proprioception On Upper Extremity Functional Skills In Children With Hemiparetic And Diparetic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05213715
- Acronym / sponsor ID
- CP / KSUU
- Conditions
- Cerebral Palsy, Somatosensory Disorders, Upper Extremity Dysfunction, Proprioceptive Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 20 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 28 Jan 2022 (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.
Cerebral Palsy (CP) is a non-progressive neurodevelopmental disorder characterized by posture and movement disorders as a result of damage to the immature brain for any reason before, during or after birth.In addition to tone, postural and neuromuscular control in children with Cerebral Palsy; Problems are also observed in communication skills, perceptual and cognitive systems and sensory systems.
Detailed description
In neurodevelopmental theory, sensory and motor systems mutually support the development of each other. In addition to the motor problems observed in SP; Sensory-motor impairment, which occurs with the effects of systems such as proprioception, tactile (touch), and vestibular (balance), emerges as the main problem. With the involvement of the central nervous system (CNS) in CP, the sensory systems are also affected along with the motor systems. The involvement of the sensory system is seen in 45% of these children and presents with a white matter lesion. One of the important factors affecting the activities of daily living (ADL) in children with Cerebral Palsy is the deficiencies in their functions as a result of the affected upper extremity. Deficiencies in sensory input can cause delays in learning new motor movements. This can result in disuse of the extremities and sensitivity. The somatosensory cortex, which is important for sensory integration; It is the area of the brain that is sensitive to tactile sensations from the body. It is known that the somatosensory system, which carries these tactile stimuli to the somatosensory cortex, is active from the early stage of life. Sensory and motor interactions experienced in the early stages of life are important for motor development even in the early stages. The improvement in measurable cortical responses of the tactile system; It starts from the 8th week of intrauterine and continues until the postpartum period. In the newborn period, the infant's responses to tactile and proprioceptive stimuli play an important role in the development of motor, cognitive, social and communication skills during infancy and early childhood. The aim of this study is to investigate the effects of somatosensory perception and proprioception on upper extremity functional skills in children with hemiparetic and diparetic CP.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1/Children with diparetic cerebral palsy | – | Other: assessment1/Children with diparetic cerebral palsy |
| 2/Children with hemiparetic cerebral palsy | – | Other: assessment2/Children with hemiparetic cerebral palsy |
| 3/healty peer aged children | – | Other: assessment3/healty peer aged children |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- children with cerebral palsy and healty peer aged children
Key inclusion criteria (7 listed)
- Diagnosed with Hemiparetic and Diparetic CP with Gross Motor Function Classification System (GMFCS) Level ≤ 3
- Children with ≤ 2 upper extremity muscles according to the Modified Ashworth Scale (MAS)
- Children with Manual Skills Classification System (MACS) ≤ 3
- Not being diagnosed with mental disability by the RAM (Guidance Research Center)
- Children with CP aged 6-18 years
Key exclusion criteria (2 listed)
- Joint contracture in the shoulder, elbow and hand-wrist
- Having any hearing or 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 |
|---|---|---|
| assessmentassessment of upper extremity functions, somatosensorial functions and proprioseption of upper extremity | Other | 1/Children with diparetic cerebral palsy, 2/Children with hemiparetic cerebral palsy, 3/healty peer aged children |
Primary outcome
upper extremity proprioseption test
Time frame: first day of assessment
Measurements will be done by a goniometer for bilateral upper extremity shoulder flexion-abduction, elbow flexion-extension, supination-pronation, hand-wrist flexion. The eyes will be closed or the head turned to the opposite direction of the evaluated area. The difference between the value for the full range and the value for the half range will be recorded on the test paper as angular. Higher angular difference indicates worse proprioception.
Kinesthesia Test
Time frame: first day of assessment
The difference in the distance between the point where the child ends the movement and the end point of the real line is measured on the evaluation paper with a ruler. The total value of the right and left obtained is recorded by subtracting from 50. The higher the difference, the better the kinesthesia. The test will be applied bilaterally.
somatosensory perception of upper extremity (touch stimulus localization test)
Time frame: first day of assesment
Touch stimulus localization test is one of the Ayres' Southern California Sensory Integration and Praxis Test (SIPT) somatosensory perception subtests. Before starting the test, the child is asked to close his eyes. The hand, wrist and forearm are touched once with a pencil in order, first in the pronation position and then in the supination position, and the child is asked to point to the touched area with his finger. The distance between the place touched by the pen and the place indicated by the child is measured with a ruler and recorded on the evaluation sheet in cm. The test is applied bilaterally. Evaluation; The farther the distance between the real touched place and the child touches, the worse tactile perception is interpreted, the closer the real touched place and the child's touched place, the better it is interpreted to show tactile perception.
somatosensory perception of upper extremity (double-touch stimulus localization test)
Time frame: first day of assesment
Double-touch stimulus localization test is one of the Ayres' Southern California Sensory Integration and Praxis Test (SIPT) somatosensory perception subtests. Before starting the test, the child is asked to close his eyes. With 2 separate pens, you can simultaneously use two different points such as left hand-right cheek, right hand-left hand, left cheek-right cheek, left hand-left cheek, right hand-left cheek, right hand-right cheek while eyes are closed. tactile. The child is asked to say or show both points touched. If the child knows both points, 2 points, 1 point if he knows one, 0 points if he does not know, and a total score is obtained. In scoring, where the best value is measured out of 14, the lower this value is interpreted as the worse tactile perception, the closer it is to this value, the better tactile perception is interpreted.
somatosensory perception of upper extremity (finger recognition test)
Time frame: first day of assesment
Finger recognition test is one of the Ayres' Southern California Sensory Integration and Praxis Test (SIPT) somatosensory perception subtests. Before starting the test, the child is asked to close his eyes. He is asked to put his hands on the table and the child's eyes are closed and 16 different points (8 right hand-8 left hand) are touched with a pencil. They are asked to point to the touched points with their fingers or to express audibly. For each point touched, scoring is done as 1 for a correct answer and 0 for an incorrect answer. The test was performed bilaterally. The patient's total score is obtained by summing the scores for both hands. In this measurement method, which is evaluated out of 16; The closer the value to 16 indicates good tactile perception, while the farther away it is, the worse it indicates tactile perception.
somatosensory perception of upper extremity (right-left discrimination test)
Time frame: first day of assesment
Right-left discrimination test is one of the Ayres' Southern California Sensory Integration and Praxis Test (SIPT) somatosensory perception subtests. The child is asked to repeat the same by giving 10 body imitation commands. With the paper with the test questions in the hands of the physiotherapist, the assessment of the child begins. The score for the test is 2 points if he answers correctly in the first three seconds, 1 point if he answers in ten seconds, and 0 points if he fails to answer. The total score is recorded by summing all the sub-scores of the child from the 10 questions in the test.
The Jebsen Taylor Hand Function Test (JTHFT)
Time frame: first day of assesment
The Jebsen Taylor Hand Function Test (JTHFT) will be used to assess upper extremity functional skills. JTEFT, which is used in the 6-18 age range, consists of serial subtests representing hand function in daily life. The application of this test, which consists of 6 items, takes 15-45 minutes. A scaled board is used to provide a standard arrangement of objects in the test. The time when all activities are done is recorded with a stopwatch. Higher duration indicates worse hand function.
3 secondary outcomes
manuel ability classification system (MACS)
Time frame: first day of assessment
Gross Motor Function Classification System(GMFCS)
Time frame: first day of assessment
demographic information
Time frame: first day of assessment
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 1 Apr 2022.
- 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.
hatice adıgüzel, PhD study chair
Kahramanmaras Sutcu Imam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Somatosensory Disorders, run by Kahramanmaras Sutcu Imam 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 7 inclusion and 2 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 1 Apr 2022. 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?
upper extremity proprioseption test (time frame: first day of assessment). The study lists 7 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 1 Apr 2022.