NCT06071182

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 29, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2023

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2023

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2023

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

October 3, 2023

Last Update Submit

February 16, 2024

Conditions

Keywords

TherapyRehabilitataionVideo game

Outcome Measures

Primary Outcomes (4)

  • 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.

    The change from baseline box and block test score at week 4

  • 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.

    The change from baseline nine hole peg test score at week 4

  • Grip strength

    Analog dinamometer is used. Three times maximal grip strength is measured for both hands.

    The change from baseline dinamometer score at week 4

  • Range of movement

    Universal goniometers is used. Wrist flexion, wrist extension, radial and ulnar deviation scores (for both hands) are measured.

    The change from baseline universal goniometer score at week 4

Study Arms (2)

Task-oriented therapy

EXPERIMENTAL

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

Device: Task-oriented Fruit ninja game

Sham-controlled

SHAM COMPARATOR

Same time traditional therapy + 5 minutes sham intervention

Other: sham-controlled therapy

Interventions

The fruit ninja game were played from tablet PC 20 minutes in a day and 2 times in a week for 4 weeks

Task-oriented therapy

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.

Sham-controlled

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Those whose family did not sign a participation consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzurum Technical University

Erzurum, 25050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Mehmet SÖNMEZ, MSc

    Erzurum Technical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2023

First Posted

October 6, 2023

Study Start

July 29, 2023

Primary Completion

October 21, 2023

Study Completion

November 15, 2023

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations