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Role of Virtual Reality in Hand Rehabilitation for Children With Cerebral Palsy

Primary Purpose

Physical Disability, Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Leap Motion Sensor
Neurodevelopmental Treatment Approach
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Physical Disability focused on measuring cerebral palsy, virtual rehabilitation, hand rehabilitation, leap motion

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Gross Motor Functional Level should be I or II.

Exclusion Criteria:

  • Epilepsy
  • Visual Impairment
  • Cognitive Problem
  • Inability to hold and release the objects

Sites / Locations

  • Silivri Rehabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Leap Motion Sensor

Neurodevelopmental Treatment Approach

Arm Description

The Leap Motion Sensor is an optical hand tracking module that captures the movements of hands with unparalleled accuracy.

Neurodevelopment treatment approach is used to influence the quality of the motor response and is carefully matched to the patient's abilities to use sensory information and adapt movements.

Outcomes

Primary Outcome Measures

ABILHANDS-kids Scoring Before Study
Measure of manual ability for children with upper limb impairments before study.
ABILHANDS-kids Scoring After Study
Measure of manual ability for children with upper limb impairments after study.
Manual Ability Classification System
It describes how children with cerebral palsy use their hands to handle objects in daily activities.
Gross Motor Function Classification
It description of a child's current motor function
Box and Block Test Before Study
It measures unilateral gross manual dexterity before study.
Box and Block Test After Study
It measures unilateral gross manual dexterity after study.
9 Hole Peg Test Before Study
It is a standardized, quantitative assessment used to measure finger dexterity before study.
9 Hole Peg Test After Study
It is a standardized, quantitative assessment used to measure finger dexterity after study.
Pink Tower Montessori Test Before Study
It measures performance based hand skill before study.
Pink Tower Montessori Test After Study
It measures performance based hand skill after study.

Secondary Outcome Measures

Full Information

First Posted
April 26, 2021
Last Updated
July 5, 2021
Sponsor
Abant Izzet Baysal University
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1. Study Identification

Unique Protocol Identification Number
NCT04954144
Brief Title
Role of Virtual Reality in Hand Rehabilitation for Children With Cerebral Palsy
Official Title
The Effect of Fine Motor Grip Studies in Virtual Reality Environment on Performance-Based Hand Skills in Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 16, 2021 (Actual)
Primary Completion Date
April 13, 2021 (Actual)
Study Completion Date
April 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abant Izzet Baysal 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 (CP) is a neurodevelopmental dysfunction which is permanent, non-progressive, and caused by brain insult or injury.Although the basic finding of CP is having motor function problems, visual, auditory, cognitive and behavioural problems are also seen in CP.Having these problems interfere the functional independence of children with CP, so their daily life of activities is limited.One of the way of increasing the functional independence of these children is providing them hand rehabilitation.In the event of having hand rehabilitation, children would achieve more daily living skills.Although having hand rehabilitation is crucial for these children, they would lose their motivation on this by the time because rehabilitation is a long process,For that reason, new therapy techniques are tried by therapists to motivate these children during their rehabilitation seances.Virtual reality rehabilitation is one of these new techniques used for designing enjoyable and effective seances.Especially leap motion sensors are preferred to create virtual environment, because they are cheap, portable, touchless and easy to use.These sensors can detect hand movements and recognize hand gestures by using infrared.Our study was aimed to investigate the effect of fine motor grip studies in virtual reality environment on performance based hand skills in children with CP.Thirty two children with CP (6-18) were included in this study.Children were randomly assigned into two equal-sized groups: control and study groups.Participants in both groups received a neurodevelopmental therapy program.The study group additionally received virtual reality rehabilitation programme. In control group, neurodevelopmental treatment was provided 45 mins,2 d/week for 2 successive months.In study group, neurodevelopmental treatment was provided 30 mins and virtual rehabilitation programme was provided 15 mins, 2 d/week for 2 successive months. To evaluate the performance based hand skills; Box and Block Test, Nine Hole Peg Test and Pink Tower (Montessori) Test were used.
Detailed Description
Cerebral palsy (CP) can be defined as a permanent, non-progressive, motor function, posture and developmental disorder that causes movement limitation due to a lesion that can occur in the brain due to prenatal, perinatal and postnatal reasons.Although the etiology of the disease cannot be determined precisely, the reasons causing SP; It is stated that it occurs in prenatal, perinatal and postnatal periods. Sometimes, more than one factor can be found together.Another common problem in individuals with CP is seen in upper extremity functions, and limiting upper extremity functions also affects the independence of daily living activities. The condition of the hand in the early period of rehabilitation has an important place for upper extremity functions in the future.In this respect, it is very important to include a program to develop manual skills in the rehabilitation process in order to make children with CP more independent in daily life activities.Neurodevelopmental Treatment Approach, widely used in the treatment of children with Cerebral Palsy; It is a method that tries to control sensorimotor components of muscle tone, reflexes, abnormal movement patterns, postural control, sensory-perception and memory problems with special techniques.Virtual reality is a three-dimensional simulation that makes you feel to be in any "place" and provides this by giving various inputs to our sensory organs. According to motor control and motor learning theory, it is important to carry out repetitive, target-oriented studies that increase motivation in the rehabilitation of children with Cerebral Palsy and it is important to include games and entertainment in the treatment program. To achieve this, making virtual reality a component of rehabilitation can cause the treatment process to be more functional and effective.Research has shown that computer games designed for a specific purpose can increase the motivation of children to increase the use of the affected extremities and positively improve the strength and functionality of the affected muscles.Leap Motion Sensors have been developed to detect hand movements. It can detect the movement of the hand by emitting infrared rays in a restricted area. Physiotherapists have stated that virtual reality rehabilitation applied with Leap Motion Sensors can be an effective method that increases motivation in the treatment process in children with special needs.Our study was aimed to investigate the effect of fine motor grip studies in virtual reality environment on performance based hand skills in children with CP.After the approval of the ethics committee, children with cerebral palsy were included in the study.Parental approval was obtained.Reports from Health Council was examined to check diagnosis of children.The study was performed in three centers: University of Abant Izzet Baysal, Silivri Rehabilitation Center and Reyhan Rehabilitation Center.Thirty two children with CP (6-18) were included in this study.Exclusion criteria were; epilepsy history, cognitive problems, visual impairment, having problem on holding and releasing the objects.Children were randomly assigned into two equal-sized groups: control and study groups.Participants in both groups received a neurodevelopmental therapy program.The study group additionally received virtual reality rehabilitation programme.As a normal developmental treatment method, functional skills exercises, inhibition of abnormal movement patterns, sensory-motor integration in purposeful movements, stretching and strengthening exercises, and daily life activities were trained.As a virtual reality treatment method, object catching, firefly, bee-batting games were used, which improved performance-dependent dexterity by integrating leap motion sensors into the laptop.In control group, neurodevelopmental treatment was provided 45 mins,2 days/week for 2 successive months.In study group, neurodevelopmental treatment was provided 30 mins and virtual rehabilitation programme was provided 15 mins, 2 days/week for 2 successive months.In virtual reality treatment, each game was studied for 5 minutes and 3 games for a total of 15 minutes.Before and after the study, tests that measure performance-related dexterity were applied and the previous and next results of the groups were compared.SPSS statistics program was used for statistical evaluation of data belonging to participants.In statistical evaluations, p <0.05 was considered as significant.In the data analysis of the study, in order to select the appropriate statistical analysis, whether the distribution of the data is suitable for normal distribution was determined by the "one-sample Kolmogorov-Smirnov" test."Independent T Test" was used to compare age, height, body weight, the measures pre-treatment and post-treatment, .Gender and affected sides were compared by using "Chi-Square Test".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Disability, Cerebral Palsy
Keywords
cerebral palsy, virtual rehabilitation, hand rehabilitation, leap motion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Leap Motion Sensor
Arm Type
Experimental
Arm Description
The Leap Motion Sensor is an optical hand tracking module that captures the movements of hands with unparalleled accuracy.
Arm Title
Neurodevelopmental Treatment Approach
Arm Type
Experimental
Arm Description
Neurodevelopment treatment approach is used to influence the quality of the motor response and is carefully matched to the patient's abilities to use sensory information and adapt movements.
Intervention Type
Device
Intervention Name(s)
Leap Motion Sensor
Intervention Description
As a virtual reality treatment method, leap motion sensor was integrated with laptop computer and participants played object capture, firefly, bee-batting games to improve performance based hand skills.
Intervention Type
Other
Intervention Name(s)
Neurodevelopmental Treatment Approach
Intervention Description
It is a method that tries to control sensorimotor components of muscle tone, reflexes, abnormal movement patterns, postural control, sensory-perception and memory problems with special techniques.
Primary Outcome Measure Information:
Title
ABILHANDS-kids Scoring Before Study
Description
Measure of manual ability for children with upper limb impairments before study.
Time Frame
Day 1
Title
ABILHANDS-kids Scoring After Study
Description
Measure of manual ability for children with upper limb impairments after study.
Time Frame
Day 56
Title
Manual Ability Classification System
Description
It describes how children with cerebral palsy use their hands to handle objects in daily activities.
Time Frame
Day 1
Title
Gross Motor Function Classification
Description
It description of a child's current motor function
Time Frame
Day 1
Title
Box and Block Test Before Study
Description
It measures unilateral gross manual dexterity before study.
Time Frame
Day 1
Title
Box and Block Test After Study
Description
It measures unilateral gross manual dexterity after study.
Time Frame
Day 56
Title
9 Hole Peg Test Before Study
Description
It is a standardized, quantitative assessment used to measure finger dexterity before study.
Time Frame
Day 1
Title
9 Hole Peg Test After Study
Description
It is a standardized, quantitative assessment used to measure finger dexterity after study.
Time Frame
Day 56
Title
Pink Tower Montessori Test Before Study
Description
It measures performance based hand skill before study.
Time Frame
Day 1
Title
Pink Tower Montessori Test After Study
Description
It measures performance based hand skill after study.
Time Frame
Day 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Gross Motor Functional Level should be I or II. Exclusion Criteria: Epilepsy Visual Impairment Cognitive Problem Inability to hold and release the objects
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayşe Neriman Narin, Asst.Prof
Organizational Affiliation
Abant Izzet Baysal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Silivri Rehabilitation Center
City
Istanbul
State/Province
Silivri
ZIP/Postal Code
34520
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Role of Virtual Reality in Hand Rehabilitation for Children With Cerebral Palsy

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