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

NCT06398119 | Completed DMC

• 1 other identifier: Hail University
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Traditional Treatment Arm

ACTIVE COMPARATOR

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; Other: Virtual Reality Program

Virtual Reality Treatment Arm

EXPERIMENTAL

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; Other: Virtual Reality Program

Interventions

Traditional Treatment Program OTHER

Traditional Treatment Program for improving hand function

Traditional Treatment Arm; Virtual Reality Treatment Arm

Virtual Reality Program OTHER

Virtual Reality Program for improving hand function

Traditional Treatment Arm; Virtual Reality Treatment Arm

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umm Al-Qura University: lead
• University of Hail: collaborator

Study Sites (1)

Maternity and Children Hospital

Ha'il, 55471, Saudi Arabia

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Shamekh M Elshamy, Ph.D.

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 28, 2024
• First Posted: May 3, 2024
• Study Start: January 10, 2024
• Primary Completion: March 30, 2024
• Study Completion: April 8, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)