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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06398119
• Other study ID #: Hail University
• Status: Completed
• Phase: N/A
• Start date: January 10, 2024
• Est. completion date: April 8, 2024

Study information

• Verified date: April 2024
• Source: Umm Al-Qura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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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Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 8, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• Traditional Treatment Program
Traditional Treatment Program for improving hand function
• Virtual Reality Program
Virtual Reality Program for improving hand function

Locations

Country	Name	City	State
Saudi Arabia	Maternity and Children Hospital	Ha'il

Sponsors (2)

Lead Sponsor	Collaborator
Umm Al-Qura University	University of Hail

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline spasticity degrees at 3 months	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
Primary	Change from baseline grip and pinch strength at 3 months	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