Clinical trial NCT06071182: Task-oriented Game Therapy Using Enhances Functions in Children With Cerebral Palsy.
Official title: Task-oriented Game Therapy Using Free Internet-videogame Enhances Upper Extremity Functions for Children With Cerebral Palsy: A Sham-controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Therapy
Rehabilitataion
Video game
Lead sponsor: Erzurum Technical University
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cerebral Palsy is an umbrella definition that refers to a disorder that occurs after a problem affecting a person's 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 (random.org)) 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 (https://www.youtube.com/watch?v=cAb0cAviA1s) 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.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with Cerebral Palsy with a doctor's report (Based on patient reports)
* Being between the ages of 6-18
* Having upper extremity involvement
* Being between levels 1-3 on the Expanded Gross Motor Function Classification (GMFS)
* Having the mental competence to understand the game being played

Exclusion Criteria:

* Those whose family did not sign a participation consent form

Primary outcomes:
measure: Manual Dexterity
timeFrame: The change from baseline box and block test score at week 4
measure: Hand function
timeFrame: The change from baseline nine hole peg test score at week 4
measure: Grip strength
timeFrame: The change from baseline dinamometer score at week 4
measure: Range of movement
timeFrame: The change from baseline universal goniometer score at week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Erzurum Technical University
Study officials:
affiliation: Erzurum Technical University
name: Mehmet SÖNMEZ, MSc
role: STUDY_DIRECTOR
References: