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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05846542
Other study ID # GIBTU-FTR-DGK-3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 25, 2023
Est. completion date October 15, 2023

Study information

Verified date April 2024
Source Gaziantep Islam Science and Technology University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The video-based therapy applications; will be applied in a non-three-dimensional (with desktop screen) way. In this application, there are different types of exercise programs that will work the upper extremity movements. The video-based therapy applications will be applied to individuals with Cerebral Palsy (CP) who will be included in the study with the Xbox Kinect 3600 (Microsoft, Washington, USA) device. This study was planned to examine the effect of video-based therapy on upper extremity selective motor control and proprioception in individuals with Cerebral Palsy.


Description:

Spastic CP will be participate the study between the ages of 4 and 18 years. Children's classified with GMFCS and MACS. The eligible participants will be allocated two groups, including video-game based therapy group and conventional physiotherapy control group. All the assessments will be performed before and after the therapy in the 8-week therapy groups.The control group individuals will be given a conventional physiotherapy two days per week for a total of 8 weeks (conventional physiotherapy session will last 45 minutes). The video-game based therapy group will receive a conventional physiotherapy and video-game based therapy, two days a week for a total of 8 weeks (15 minutes conventional physiotherapy session+30 minutes video-game based therapy). All sessions will be performed in the clinic with the specialist physiotherapist.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date October 15, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers No
Gender All
Age group 4 Years to 18 Years
Eligibility Inclusion Criteria: - Diagnosis of Cerebral Palsy voluntary participation, - Age between 4-18 years - GMFCS Level I-II-III - MACS Level I-II-III Exclusion Criteria: - Not voluntary to participate in the research, - Botox in the last 6 months, - Upper limb or spine surgeries in the last 6 months

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Video-game based therapy
Video-game based therapy will be designed for the individual basis for the upper extremity.
Conventional physiotherapy
Conventional physiotherapy within a specific program

Locations

Country Name City State
Turkey Demet Gözaçan Karabulut Gaziantep None Selected

Sponsors (1)

Lead Sponsor Collaborator
Gaziantep Islam Science and Technology University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gross Motor Function Classification System (GMFCS) Assessing functional level and motor function. Gross motor functions of children with CP are classified in five levels with GMFCS. This is a classification system based on the child's self-initiated movements with emphasis on sitting, displacement and mobility. At Baseline
Primary Manuel ability classification system (MACS) This is a classification system based on the grasping and releasing objects in daily life, and how they use their hands while holding objects. It is classify the hand skills of children with CP between the ages of 4-18.Children with CP are classified in five levels with MACS. The higher level indicates worse hand function At Baseline
Primary Change from Baseline ABILHAND-Kids at 8 weeks Abilhand Kids evaluates manual ability in children with upper extremity disorders. It consists of 21 items and confirmed in CP. The lowest score that can be obtained from the scale is 0 and the highest score is 42. It can be stated that higher scores correspond to more difficulty in activities. Change from Baseline at 8 weeks
Primary Change from Baseline Selective Control of the Upper Extremity Scale (SCUES) at 8 weeks It is a practical and useful assessment tool developed to evaluate upper extremity selective motor control. The administration of the SCUES required patients to perform specific isolated movement patterns at various levels including: shoulder (abduction/adduction); elbow (flexion/extension); forearm (supination/pronation); wrist (flexion/extension); and fingers/thumb (grasp/release). The total score of the SCUES ranges between 0 and 15 and higher scores indicate better selective motor control. Change from Baseline at 8 weeks
Primary Change from Baseline Clinometer at 8 weeks Caliper clinometer (App Development) is a phone application used to measure angle changes in the relevant region. In the evaluation of shoulder and elbow proprioception change will be evaluated. Change from Baseline at 8 weeks
Primary Change from Baseline Entertainment Scale at 8 weeks The entertainment level of sessions and therapy training for individuals will be evaluated with a 0-10 point numerical rating scale (entertainment scale). There are numbers from 0 to 10 on the horizontal line of 10 cm. 0 "Not fun" on the line in the scale; 10 represents "a lot of fun". Entertainment rating will be recorded numerically from 0 to 10. Change from Baseline at 8 weeks
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