Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04954144 |
Other study ID # |
AIBU-FTR-ANN-01 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 16, 2021 |
Est. completion date |
April 20, 2021 |
Study information
Verified date |
July 2021 |
Source |
Abant Izzet Baysal University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Cerebral Palsy (CP) is a neurodevelopmental dysfunction which is permanent, non-progressive,
and caused by brain insult or injury.Although the basic finding of CP is having motor
function problems, visual, auditory, cognitive and behavioural problems are also seen in
CP.Having these problems interfere the functional independence of children with CP, so their
daily life of activities is limited.One of the way of increasing the functional independence
of these children is providing them hand rehabilitation.In the event of having hand
rehabilitation, children would achieve more daily living skills.Although having hand
rehabilitation is crucial for these children, they would lose their motivation on this by the
time because rehabilitation is a long process,For that reason, new therapy techniques are
tried by therapists to motivate these children during their rehabilitation seances.Virtual
reality rehabilitation is one of these new techniques used for designing enjoyable and
effective seances.Especially leap motion sensors are preferred to create virtual environment,
because they are cheap, portable, touchless and easy to use.These sensors can detect hand
movements and recognize hand gestures by using infrared.Our study was aimed to investigate
the effect of fine motor grip studies in virtual reality environment on performance based
hand skills in children with CP.Thirty two children with CP (6-18) were included in this
study.Children were randomly assigned into two equal-sized groups: control and study
groups.Participants in both groups received a neurodevelopmental therapy program.The study
group additionally received virtual reality rehabilitation programme. In control group,
neurodevelopmental treatment was provided 45 mins,2 d/week for 2 successive months.In study
group, neurodevelopmental treatment was provided 30 mins and virtual rehabilitation programme
was provided 15 mins, 2 d/week for 2 successive months. To evaluate the performance based
hand skills; Box and Block Test, Nine Hole Peg Test and Pink Tower (Montessori) Test were
used.
Description:
Cerebral palsy (CP) can be defined as a permanent, non-progressive, motor function, posture
and developmental disorder that causes movement limitation due to a lesion that can occur in
the brain due to prenatal, perinatal and postnatal reasons.Although the etiology of the
disease cannot be determined precisely, the reasons causing SP; It is stated that it occurs
in prenatal, perinatal and postnatal periods. Sometimes, more than one factor can be found
together.Another common problem in individuals with CP is seen in upper extremity functions,
and limiting upper extremity functions also affects the independence of daily living
activities. The condition of the hand in the early period of rehabilitation has an important
place for upper extremity functions in the future.In this respect, it is very important to
include a program to develop manual skills in the rehabilitation process in order to make
children with CP more independent in daily life activities.Neurodevelopmental Treatment
Approach, widely used in the treatment of children with Cerebral Palsy; It is a method that
tries to control sensorimotor components of muscle tone, reflexes, abnormal movement
patterns, postural control, sensory-perception and memory problems with special
techniques.Virtual reality is a three-dimensional simulation that makes you feel to be in any
"place" and provides this by giving various inputs to our sensory organs. According to motor
control and motor learning theory, it is important to carry out repetitive, target-oriented
studies that increase motivation in the rehabilitation of children with Cerebral Palsy and it
is important to include games and entertainment in the treatment program. To achieve this,
making virtual reality a component of rehabilitation can cause the treatment process to be
more functional and effective.Research has shown that computer games designed for a specific
purpose can increase the motivation of children to increase the use of the affected
extremities and positively improve the strength and functionality of the affected
muscles.Leap Motion Sensors have been developed to detect hand movements. It can detect the
movement of the hand by emitting infrared rays in a restricted area. Physiotherapists have
stated that virtual reality rehabilitation applied with Leap Motion Sensors can be an
effective method that increases motivation in the treatment process in children with special
needs.Our study was aimed to investigate the effect of fine motor grip studies in virtual
reality environment on performance based hand skills in children with CP.After the approval
of the ethics committee, children with cerebral palsy were included in the study.Parental
approval was obtained.Reports from Health Council was examined to check diagnosis of
children.The study was performed in three centers: University of Abant Izzet Baysal, Silivri
Rehabilitation Center and Reyhan Rehabilitation Center.Thirty two children with CP (6-18)
were included in this study.Exclusion criteria were; epilepsy history, cognitive problems,
visual impairment, having problem on holding and releasing the objects.Children were randomly
assigned into two equal-sized groups: control and study groups.Participants in both groups
received a neurodevelopmental therapy program.The study group additionally received virtual
reality rehabilitation programme.As a normal developmental treatment method, functional
skills exercises, inhibition of abnormal movement patterns, sensory-motor integration in
purposeful movements, stretching and strengthening exercises, and daily life activities were
trained.As a virtual reality treatment method, object catching, firefly, bee-batting games
were used, which improved performance-dependent dexterity by integrating leap motion sensors
into the laptop.In control group, neurodevelopmental treatment was provided 45 mins,2
days/week for 2 successive months.In study group, neurodevelopmental treatment was provided
30 mins and virtual rehabilitation programme was provided 15 mins, 2 days/week for 2
successive months.In virtual reality treatment, each game was studied for 5 minutes and 3
games for a total of 15 minutes.Before and after the study, tests that measure
performance-related dexterity were applied and the previous and next results of the groups
were compared.SPSS statistics program was used for statistical evaluation of data belonging
to participants.In statistical evaluations, p <0.05 was considered as significant.In the data
analysis of the study, in order to select the appropriate statistical analysis, whether the
distribution of the data is suitable for normal distribution was determined by the
"one-sample Kolmogorov-Smirnov" test."Independent T Test" was used to compare age, height,
body weight, the measures pre-treatment and post-treatment, .Gender and affected sides were
compared by using "Chi-Square Test".