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Completed

NCT Number: NCT06398119

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

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

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maternity and Children Hospital

Ha'il, 55471, Saudi Arabia

About this study

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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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

traditional treatment program

Other

Traditional Treatment Program for improving hand function

Virtual Reality Program

Other

Virtual Reality Program for improving hand function

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Umm Al-Qura University

Other

Collaborators

  • University of Hail

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 3, 2024
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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