Clinical trial NCT05013814: The Effect of Tactile Deficit on Motor Function in Unilateral Cerebral Palsy
Official title: Comparison of the Tactile Functions and the Effects of Possible Tactile Deficit on Motor Function in Unilateral Cerebral Palsy and the Typically Developed Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Rehabilitation
Tactile Perception
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 80
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of 2 groups. In the group of typically developed children, there are healthy children who do not have a disease that will affect normal development. The other group includes children diagnosed with unilateral cerebral palsy.

Brief summary: Cerebral palsy(CP) is the most common cause of disability in childhood. The motor spectrum of disorders is characterized by abnormal muscle tone, posture, and movement. The motor disorders of CP are often accompanied by disturbances of sensation, perception, cognition and behavior. Besides classical appearance of symptomatology, tactile impairment takes an important place to be evaluated. Assessment of the integrity of tactile function composes of two main steps: tactile registration and tactile perception. Our main goal is the define the effect of tactile impairment on hand motor function with the usage of identical assessment tools in patients with unilateral cerebral palsy (UCP) and typically developed children (TDC).


Eligibility criteria: Inclusion Criteria:

* Ages between 5-15 years
* Being evaluated as Class I-II-III in Gross Motor Function Classification System
* Being evaluated as Class I-II-III in Manual Ability Classification System

Exclusion Criteria:

* Inability to understand and/or follow test instructions due to intellectual or behavioral difficulties
* History of upper extremity botulinum toxin type A injection in the last three months,
* Previous upper extremity orthopedic surgery
* History of major trauma, and visual impairment

Primary outcomes:
measure: Number of participants with tactile dysfunction in both groups
timeFrame: 1 day (Single time point)
measure: Mean score of gross manual dexterity assessment test in all participants
timeFrame: 1 day (Single time point)
measure: Mean score of hand grip strength test in all participants
timeFrame: 1 day (Single time point)
measure: Mean score of hand function test in all participants
timeFrame: 1 day (Single time point)
measure: Mean score of finger dexterity assessment test in all participants
timeFrame: 1 day (Single time point)
measure: Mean score of finger grip strength test in all participants
timeFrame: 1 day (Single time point)
Secondary outcomes:
measure: Mean score of gross manual dexterity assessment test according to the tactile function
timeFrame: 1 day (Single time point)
measure: Mean score of hand grip strength test according to the tactile function
timeFrame: 1 day (Single time point)
measure: Mean score of finger grip strength test according to the tactile function
timeFrame: 1 day (Single time point)
measure: Mean score of hand function test according to the tactile function
timeFrame: 1 day (Single time point)
measure: Mean score of finger dexterity assessment test according to the tactile function
timeFrame: 1 day (Single time point)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Pendik Education and Research Hospital
Study officials:
affiliation: Marmara University
name: Evrim Karadag-Saygi, MD
role: STUDY_DIRECTOR
References: