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

July 5, 2021 updated by: Ayşe Neriman NARİN, Abant Izzet Baysal University

The Effect of Fine Motor Grip Studies in Virtual Reality Environment on Performance-Based Hand Skills in Children With Cerebral Palsy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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".

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Silivri
      • Istanbul, Silivri, Turkey, 34520
        • Silivri Rehabilitation Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Leap Motion Sensor
The Leap Motion Sensor is an optical hand tracking module that captures the movements of hands with unparalleled accuracy.
Device: Leap Motion Sensor
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.
Other: Neurodevelopmental Treatment Approach
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.
EXPERIMENTAL: Neurodevelopmental Treatment Approach
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.
Other: Neurodevelopmental Treatment Approach
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ABILHANDS-kids Scoring Before Study
Time Frame: Day 1
Measure of manual ability for children with upper limb impairments before study.
Day 1
ABILHANDS-kids Scoring After Study
Time Frame: Day 56
Measure of manual ability for children with upper limb impairments after study.
Day 56
Manual Ability Classification System
Time Frame: Day 1
It describes how children with cerebral palsy use their hands to handle objects in daily activities.
Day 1
Gross Motor Function Classification
Time Frame: Day 1
It description of a child's current motor function
Day 1
Box and Block Test Before Study
Time Frame: Day 1
It measures unilateral gross manual dexterity before study.
Day 1
Box and Block Test After Study
Time Frame: Day 56
It measures unilateral gross manual dexterity after study.
Day 56
9 Hole Peg Test Before Study
Time Frame: Day 1
It is a standardized, quantitative assessment used to measure finger dexterity before study.
Day 1
9 Hole Peg Test After Study
Time Frame: Day 56
It is a standardized, quantitative assessment used to measure finger dexterity after study.
Day 56
Pink Tower Montessori Test Before Study
Time Frame: Day 1
It measures performance based hand skill before study.
Day 1
Pink Tower Montessori Test After Study
Time Frame: Day 56
It measures performance based hand skill after study.
Day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abant Izzet Baysal University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ayşe Neriman Narin, Asst.Prof, Abant Izzet Baysal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 16, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 13, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 20, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AIBU-FTR-ANN-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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