NCT04954144

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

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

Study Start

First participant enrolled

February 16, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2021

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
Last Updated

July 8, 2021

Status Verified

July 1, 2021

Enrollment Period

2 months

First QC Date

April 26, 2021

Last Update Submit

July 5, 2021

Conditions

Keywords

cerebral palsyvirtual rehabilitationhand rehabilitationleap motion

Outcome Measures

Primary Outcomes (10)

  • ABILHANDS-kids Scoring Before Study

    Measure of manual ability for children with upper limb impairments before study.

    Day 1

  • ABILHANDS-kids Scoring After Study

    Measure of manual ability for children with upper limb impairments after study.

    Day 56

  • Manual Ability Classification System

    It describes how children with cerebral palsy use their hands to handle objects in daily activities.

    Day 1

  • Gross Motor Function Classification

    It description of a child's current motor function

    Day 1

  • Box and Block Test Before Study

    It measures unilateral gross manual dexterity before study.

    Day 1

  • Box and Block Test After Study

    It measures unilateral gross manual dexterity after study.

    Day 56

  • 9 Hole Peg Test Before Study

    It is a standardized, quantitative assessment used to measure finger dexterity before study.

    Day 1

  • 9 Hole Peg Test After Study

    It is a standardized, quantitative assessment used to measure finger dexterity after study.

    Day 56

  • Pink Tower Montessori Test Before Study

    It measures performance based hand skill before study.

    Day 1

  • Pink Tower Montessori Test After Study

    It measures performance based hand skill after study.

    Day 56

Study Arms (2)

Leap Motion Sensor

EXPERIMENTAL

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

Device: Leap Motion SensorOther: Neurodevelopmental Treatment Approach

Neurodevelopmental Treatment Approach

EXPERIMENTAL

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

Interventions

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.

Leap Motion Sensor

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.

Leap Motion SensorNeurodevelopmental Treatment Approach

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Gross Motor Functional Level should be I or II.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Silivri Rehabilitation Center

Istanbul, Silivri, 34520, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Ayşe Neriman Narin, Asst.Prof

    Abant Izzet Baysal University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 26, 2021

First Posted

July 8, 2021

Study Start

February 16, 2021

Primary Completion

April 13, 2021

Study Completion

April 20, 2021

Last Updated

July 8, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations