Effect of Visuomotor Training Using Pablo System on Hand Function in Children With Hemiplegic Cerebral Palsy

NCT ID: NCT06398119

Last Updated: 2024-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-10

Study Completion Date

2024-04-08

Brief Summary

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The aim of this study was to investigate the efficacy of Virtual reality on hand function in Saudi children with hemiplegic cerebral palsy.

Detailed Description

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The aim of this study was to evaluate the effect of Virtual reality on hand function in children with hemiplegic CP. Forty children with hemiplegic CP were assigned randomly into two groups (A \& B). Control group (A) was received conventional rehabilitation program for the hand. Study group (B) was received conventional rehabilitation program as in group (A) in addition to virtual reality by using the Pablo system.Patients' evaluation was carried out before and after training to assess hand function.

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Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Traditional Treatment Arm

The traditional therapy program consisted of one hour provided three times a week for three months. The components of traditional therapy included weight-bearing exercises for the upper limbs, protective extensor push to activate the upper limbs' protective reactions, and passive stretching for the flexors of the wrist and elbow. In order to strengthen the muscles that oppose the spastic muscles, such as the elbow and wrist extensors, various toys were used, along with incentives to motivate the children to complete the exercises. Basic reach, grab, carry, and release techniques, in-hand manipulation techniques, and bilateral hand use are exercises that help with hand abilities.

Group Type ACTIVE_COMPARATOR

Traditional Treatment Program

Intervention Type OTHER

Traditional Treatment Program for improving hand function

Virtual Reality Program

Intervention Type OTHER

Virtual Reality Program for improving hand function

Virtual Reality Treatment Arm

For virtual reality training, the Pablo system was utilized. In both one- and two-dimensional modules, it is a game-based kind of rehabilitation. Based on the concepts of motor learning, this apparatus is used to train users. Using sensors to operate the games, the Pablo system features several boards, multiball, and handheld devices. The virtual reality program consisted of 45 minutes provided three times a week for three months.

Group Type EXPERIMENTAL

Traditional Treatment Program

Intervention Type OTHER

Traditional Treatment Program for improving hand function

Virtual Reality Program

Intervention Type OTHER

Virtual Reality Program for improving hand function

Interventions

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Traditional Treatment Program

Traditional Treatment Program for improving hand function

Intervention Type OTHER

Virtual Reality Program

Virtual Reality Program for improving hand function

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* They had a diagnosis of spastic hemiplegia derived from medical records.
* Scored I-III on the Manual Ability Classification System.
* Not have musculoskeletal disorders that would make it difficult for them to use the VR.
* They had normal or corrected hearing and vision.
* They had no prior experience with the VR.
* They comprehend and follow straightforward instructions to complete the tasks.

Exclusion Criteria

* They have had upper limb surgery within the last six months.
* They have uncontrollably occurred seizures.
* They have medical conditions that can make using virtual reality dangerous.
* They have attention deficit issues.
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Hail

OTHER

Sponsor Role collaborator

Umm Al-Qura University

OTHER

Sponsor Role lead

Responsible Party

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Shamekh Mohamed El-Shamy

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shamekh M Elshamy, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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Maternity and Children Hospital

Ha'il, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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Hail University

Identifier Type: -

Identifier Source: org_study_id

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