search
Back to results

Task-oriented Game Therapy Using Enhances Functions in Children With Cerebral Palsy.

Primary Purpose

Cerebral Palsy, Task-oriented Therapy, Video Game

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Task-oriented Fruit ninja game
sham-controlled therapy
Sponsored by
Erzurum Technical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 1. Being diagnosed with Cerebral Palsy with a doctor's report (Based on patient reports) 2. Being between the ages of 6-18 3. Having upper extremity involvement 4. Being between levels 1-3 on the Expanded Gross Motor Function Classification (GMFS) 5. Having the mental competence to understand the game being played Exclusion Criteria: Those whose family did not sign a participation consent form

Sites / Locations

  • Erzurum Technical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Task-oriented therapy

Sham-controlled

Arm Description

Traditional physiotherapy for 30 minutes a day, twice a week for 4 weeks (Passive upper extremity Normal Joint Movements, 3-way and 1 set of 10 repetitions passive stretches for the shoulder (bilateral), 2-way, 1 set of 10 repetitions passive stretches at the elbow level) + 2 times a week a day Fruit ninja game on tablet in 20 minutes

Same time traditional therapy + 5 minutes sham intervention

Outcomes

Primary Outcome Measures

Manual Dexterity
Box and Block test is used. It is a measurement tool that measures gross comprehension skills. The number of cubes thrown one by one from one compartment to the other within 1 minute of a two-compartment box containing 150 cubes with dimensions of 2.5 cm*2.5 cm*2.5 cm is evaluated. It is done separately for right and left hands.
Hand function
Nine Hole Peg test is used It is a scale that evaluates participants functionally. It measures the time it takes to attach and remove 9 thin rods to a panel with 9 holes on it with the desired hand and return it to its box.
Grip strength
Analog dinamometer is used. Three times maximal grip strength is measured for both hands.
Range of movement
Universal goniometers is used. Wrist flexion, wrist extension, radial and ulnar deviation scores (for both hands) are measured.

Secondary Outcome Measures

Full Information

First Posted
October 3, 2023
Last Updated
October 3, 2023
Sponsor
Erzurum Technical University
search

1. Study Identification

Unique Protocol Identification Number
NCT06071182
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 29, 2023 (Actual)
Primary Completion Date
October 21, 2023 (Anticipated)
Study Completion Date
November 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Erzurum Technical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Task-oriented Therapy, Video Game, Tablet Personal Computer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Task-oriented therapy
Arm Type
Experimental
Arm Description
Traditional physiotherapy for 30 minutes a day, twice a week for 4 weeks (Passive upper extremity Normal Joint Movements, 3-way and 1 set of 10 repetitions passive stretches for the shoulder (bilateral), 2-way, 1 set of 10 repetitions passive stretches at the elbow level) + 2 times a week a day Fruit ninja game on tablet in 20 minutes
Arm Title
Sham-controlled
Arm Type
Sham Comparator
Arm Description
Same time traditional therapy + 5 minutes sham intervention
Intervention Type
Device
Intervention Name(s)
Task-oriented Fruit ninja game
Intervention Description
The fruit ninja game were played from tablet PC 20 minutes in a day and 2 times in a week for 4 weeks
Intervention Type
Other
Intervention Name(s)
sham-controlled therapy
Intervention Description
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 wrist and wrist exercises were repeated for 2 minutes on a flat and smooth table. movements were made.
Primary Outcome Measure Information:
Title
Manual Dexterity
Description
Box and Block test is used. It is a measurement tool that measures gross comprehension skills. The number of cubes thrown one by one from one compartment to the other within 1 minute of a two-compartment box containing 150 cubes with dimensions of 2.5 cm*2.5 cm*2.5 cm is evaluated. It is done separately for right and left hands.
Time Frame
The change from baseline box and block test score at week 4
Title
Hand function
Description
Nine Hole Peg test is used It is a scale that evaluates participants functionally. It measures the time it takes to attach and remove 9 thin rods to a panel with 9 holes on it with the desired hand and return it to its box.
Time Frame
The change from baseline nine hole peg test score at week 4
Title
Grip strength
Description
Analog dinamometer is used. Three times maximal grip strength is measured for both hands.
Time Frame
The change from baseline dinamometer score at week 4
Title
Range of movement
Description
Universal goniometers is used. Wrist flexion, wrist extension, radial and ulnar deviation scores (for both hands) are measured.
Time Frame
The change from baseline universal goniometer score at week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. Being diagnosed with Cerebral Palsy with a doctor's report (Based on patient reports) 2. Being between the ages of 6-18 3. Having upper extremity involvement 4. Being between levels 1-3 on the Expanded Gross Motor Function Classification (GMFS) 5. Having the mental competence to understand the game being played Exclusion Criteria: Those whose family did not sign a participation consent form
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MEHMET SÖNMEZ, MSc
Phone
+905538303844
Email
mehmet.sonmez@erzurum.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Musa EYMİR, PhD
Phone
+905069466551
Email
musa.eymir@erzurum.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet SÖNMEZ, MSc
Organizational Affiliation
Erzurum Technical University
Official's Role
Study Director
Facility Information:
Facility Name
Erzurum Technical University
City
Erzurum
ZIP/Postal Code
25050
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MEHMET SONMEZ, MSc
Phone
+90 553830 38 44
Email
mehmet.sonmez@erzurum.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Task-oriented Game Therapy Using Enhances Functions in Children With Cerebral Palsy.

We'll reach out to this number within 24 hrs