NCT05667792

Brief Summary

In the study we planned, 42 individuals diagnosed with cerebral palsy will be divided into 2 groups according to age groups. Individuals aged 4-11 will be included in the child group, and individuals aged 12-18 will be included in the adolescent group. Individuals with cerebral palsy in the child and adolescent group will also be randomized and divided into treatment and control groups. In addition to the conventional treatment created in accordance with neurodevelopmental treatment approaches, video-based virtual reality games will be played for a total of 10 weeks for treatment groups in both age groups. The patients will be followed up with a video-based game application for an average of 20 minutes, after the physiotherapy and rehabilitation application, which consists of an average of 45 minutes, twice a week. Individuals in the control group in both age groups will be followed for 10 weeks with conventional treatment created in accordance with neurodevelopmental treatment approaches. The entire sample will be evaluated at the beginning of the study and at the end of the 10th week. Our main aim in the study is to compare the effects of video-based games applied in different age groups on balance, trunk proprioception, motivation and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2022

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 1, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 29, 2022

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

August 1, 2022

Last Update Submit

March 3, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • One Leg Standing Test

    The one-leg stance test is a test in which the time to stand on balance is measured on the right and left extremities of the patient, and evaluates the static balance. Change will be evaluated.

    beginning and week 10

  • Caliper Clinometer

    Caliper inclinometer is a phone protractor application used to measure angle changes in the relevant region. In the evaluation of trunk proprioception, the person is in a sitting position with the back unsupported and the feet not touching the ground, while the arms are positioned crossed on the trunk. Change will be evaluated

    beginning and week 10

  • Pediatric Motivation Scale

    The scale consists of 21 items divided into 6 subsections (effort-importance, interest-pleasure, competence, relationship, autonomy, value-benefit) and enables the evaluation of the child's motivation towards the rehabilitation program from her own perspective.The total score is 119. The higher the score, the higher the motivation. Change will be evaluated.

    beginning and week 10

  • Pediatric quality of life questionere pedsQL for Children

    The Children's Quality of Life Scale was developed to measure the quality of life of children and adolescents aged 2-18.It is scored between 0-100, with the highest score being 100. Change will be evaluated

    beginning and week 10

Study Arms (4)

Study Group- 4-11 age

EXPERIMENTAL
Device: Microsoft Kinect 360Other: Pediatric Rehabilitation

Control Group-4-11 age

PLACEBO COMPARATOR
Other: Pediatric Rehabilitation

Study Group- 12-18 age

EXPERIMENTAL
Device: Microsoft Kinect 360Other: Pediatric Rehabilitation

Control Group-12-18 age

PLACEBO COMPARATOR
Other: Pediatric Rehabilitation

Interventions

Balance and trunk proprioception games will be selected and played for the children to be included in the treatment. Children will play these games with their own body movements.

Study Group- 12-18 ageStudy Group- 4-11 age

Bobath therapy

Control Group-12-18 ageControl Group-4-11 ageStudy Group- 12-18 ageStudy Group- 4-11 age

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Being diagnosed with spastic type CP with bilateral and unilateral involvement Volunteer to participate in the study Be between the ages of 4-18 Being at 1/2 level according to Gross Motor Function Classification System Cooperate with assessments Cooperating with virtual reality therapy

You may not qualify if:

  • Botulinum toxin administration in the last 6 months Having had any surgical operation in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hatay Mustafa Kemal Üniversitesi

Antakya, Hatay, 31000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate

Study Record Dates

First Submitted

August 1, 2022

First Posted

December 29, 2022

Study Start

May 5, 2022

Primary Completion

July 5, 2022

Study Completion

July 22, 2022

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations