NCT05846542

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 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

First Submitted

Initial submission to the registry

April 24, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

April 25, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2023

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

April 24, 2023

Last Update Submit

April 17, 2024

Conditions

Keywords

Cerebral palsyVirtual realityVideo gamesUpper extremityRehabilitation

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Video-game based therapy group

EXPERIMENTAL

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).

Other: Video-game based therapyOther: Conventional physiotherapy

Conventional physiotherapy group

ACTIVE COMPARATOR

The conventional physiotherapy 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).

Other: Conventional physiotherapy

Interventions

Video-game based therapy will be designed for the individual basis for the upper extremity.

Video-game based therapy group

Conventional physiotherapy within a specific program

Conventional physiotherapy groupVideo-game based therapy group

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of Cerebral Palsy voluntary participation,
  • Age between 4-18 years
  • GMFCS Level I-II-III
  • MACS Level I-II-III

You may not qualify if:

  • Not voluntary to participate in the research,
  • Botox in the last 6 months,
  • Upper limb or spine surgeries in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Demet Gözaçan Karabulut

Gaziantep, None Selected, 27010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Demet Gözaçan Karabulut

    Gaziantep Islam Science and Technology University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 24, 2023

First Posted

May 6, 2023

Study Start

April 25, 2023

Primary Completion

October 1, 2023

Study Completion

October 15, 2023

Last Updated

April 19, 2024

Record last verified: 2024-04

Locations