Ignite Creation Date:
2024-05-06 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06071182
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2023-10-03
Brief Title:
Task-oriented Game Therapy Using Enhances Functions in Children With Cerebral Palsy
Sponsor:
Erzurum Technical University
Organization:
Erzurum Technical University
Study Overview
Official Title:
Task-oriented Game Therapy Using Free Internet-videogame Enhances Upper Extremity Functions for Children With Cerebral Palsy A Sham-controlled Study
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cerebral Palsy is an umbrella definition that refers to a disorder that occurs after a problem affecting a persons brain functions and has symptoms such as sensory motor and mental deficits Cerebral Palsy can cause serious functional losses in individuals Various rehabilitation approaches have been developed and used to eliminate these functional losses One of these approaches is a therapy technique called Task-oriented therapy which focuses on completing tasks that mostly involve functional activities that the participating individuals do actively and repeatedly There are various ways to perform task-oriented therapy These can be achieved by motivating the individual to perform various tasks cutting with scissors buttoning putting on and taking off legos etc in an active intense and repetitive manner as well as through games played on devices such as tablet computers that have emerged with the developing technology Thanks to their Android and touch features such devices can motivate people to use their upper extremities functionally Thanks to such applications rehabilitation practices can be made more fun and effective results can be obtained In the literature it was seen that video game-based rehabilitation practices were used in individuals with cerebral palsy but their effects on balance were mostly evaluated Its effect on upper extremity functional capacity was mostly limited to feasibility studies For these reasons there is no data in the literature on this subject with quality results The main purpose of this study is to determine whether upper extremity functional capacity can be improved by using the Tablet PC-based Fruit ninja game which is easily accessible today in the rehabilitation of individuals with cerebral palsy using objective measurement tools
Detailed Description:
This study is a sham-controlled prospective non-invasive field study A total of 22 participants were pre-registered for the study However when the inclusion criteria were applied 4 participants whose GMFCS score was not between levels 1-3 but met other conditions were excluded from the study without taking preliminary measurements A total of 18 participants were included in the study by taking preliminary measurements Participants were randomly distributed Computerized randomization randomorg into a nine-person study group and a placebo control group
Traditional physiotherapy Passive upper extremity Normal Joint Movements 3-way and 1 set of 10 repetitions of passive stretching for the shoulder bilateral 2-directional and 1 set of 10 repetitions of passive stretching at the elbow level was applied to the study group for 30 minutes a day twice a week for 4 weeks and then Fruit ninja game was played on the tablet for 20 minutes a day twice a week
The control group was treated with traditional physiotherapy Passive upper extremity Normal Joint Movements 3-way and 1 set of 10 repetitions passive stretching for the shoulder bilateral 2-way 1 set of 10 repetitions passive stretching at the elbow level for 30 minutes a day twice a week for 4 weeks For placebo purposes the fruit ninja game playing video httpswwwyoutubecomwatchvcAb0cAviA1s was watched on the same tablet for 3 minutes a day twice a week for 4 weeks and the movements in the game were repeated for 2 minutes on a flat and smooth table Wrist movements were performed
The first measurements of the participants participating in the study were taken after their last session the week before the study as they came to rehabilitation twice a week and their last measurements were taken after their last session in the 4th week and before their first session the following week During this period the participants families were contacted to ensure that their children did not exercise or play any computer games at home Measurements were carried out by the assistant researcher Rehabilitation practices were carried out by the principal investigator and assistant investigator
Traditional physiotherapy Passive upper extremity Normal Joint Movements 3-way and 1 set of 10 repetitions of passive stretching for the shoulder bilateral 2-directional and 1 set of 10 repetitions of passive stretching at the elbow level was applied to the study group for 30 minutes a day twice a week for 4 weeks and then Fruit ninja game was played on the tablet for 20 minutes a day twice a week
The control group was treated with traditional physiotherapy Passive upper extremity Normal Joint Movements 3-way and 1 set of 10 repetitions passive stretching for the shoulder bilateral 2-way 1 set of 10 repetitions passive stretching at the elbow level for 30 minutes a day twice a week for 4 weeks For placebo purposes the fruit ninja game playing video httpswwwyoutubecomwatchvcAb0cAviA1s was watched on the same tablet for 3 minutes a day twice a week for 4 weeks and the movements in the game were repeated for 2 minutes on a flat and smooth table Wrist movements were performed
The first measurements of the participants participating in the study were taken after their last session the week before the study as they came to rehabilitation twice a week and their last measurements were taken after their last session in the 4th week and before their first session the following week During this period the participants families were contacted to ensure that their children did not exercise or play any computer games at home Measurements were carried out by the assistant researcher Rehabilitation practices were carried out by the principal investigator and assistant investigator
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None