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

April 30, 2024 updated by: Shamekh Mohamed El-Shamy, Umm Al-Qura University

Effect of Visuomotor Training Using Pablo System on Hand Function in Children With Hemiplegic Cerebral Palsy: A Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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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Study Type

Interventional

Enrollment (Actual)

40

Phase

  • 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

  • Saudi Arabia
      • Ha'il, Saudi Arabia, 55471
        • Maternity and Children hospital

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

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

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: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Other: Traditional Treatment Program
Traditional Treatment Program for improving hand function
Other: Virtual Reality Program
Virtual Reality Program for improving hand function
Experimental: 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.
Other: Traditional Treatment Program
Traditional Treatment Program for improving hand function
Other: Virtual Reality Program
Virtual Reality Program for improving hand function

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline spasticity degrees at 3 months
Time Frame: Baseline and 3 months post-intervention
Using the Modified Ashworth Scale, the degree of upper limb spasticity was assessed. Based on the degree of muscle resistance felt by the therapist in response to a passive stretch of a joint, this sixfold scale goes from 0 (no spasticity) to 4 (fixed muscle contracture). In this study, the wrist flexor, elbow flexor, and shoulder adductor were examined. In order for the therapist to provide a score, the passive movement was done three times.
Baseline and 3 months post-intervention
Change from baseline grip and pinch strength at 3 months
Time Frame: Baseline and 3 months post-intervention
Using dynamometry, the strength of the pinch grasp and power were measured and reported in kilograms. A hydraulic hand dynamometer was used to test the power grip strength.The average of the three trials that each participant completed was used for analysis. Every child was instructed to sit on a chair that could be raised or lowered, with a backrest for support, and to keep their head in the middle. They also instructed to flex their hips and knees to a 90-degree angle and keep their feet flat on the ground. With the forearm halfway between supination and pronation, the elbow joint flexed 90 degrees, and the wrist joint in a neutral posture, the arm was positioned next to the torso. Next, the participant was instructed to grasp the dynamometer handle and squeeze it as hard as possible before letting go of it.
Baseline and 3 months post-intervention

Collaborators and Investigators

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

Sponsor

Umm Al-Qura University

Collaborators

University of Hail

Investigators

  • Principal Investigator: Shamekh M Elshamy, Ph.D., Professor

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)

January 10, 2024

Primary Completion (Actual)

March 30, 2024

Study Completion (Actual)

April 8, 2024

Study Registration Dates

First Submitted

April 28, 2024

First Submitted That Met QC Criteria

April 30, 2024

First Posted (Actual)

May 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 3, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hail University

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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