Cerebral PalsyNCT06398119
Effect of Visuomotor Training Using Pablo System on Hand Function in Children With Hemiplegic Cerebral Palsy
A study testing Traditional Treatment Program and Virtual Reality Program in people with Cerebral Palsy, run by Umm Al-Qura University at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Traditional Treatment Program and Virtual Reality Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Jan 2024to 8 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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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- Conditions
- Cerebral Palsy
- Being tested
- Traditional Treatment Program, Virtual Reality Program
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Treatment ProgramOther
Traditional Treatment Program for improving hand function
Virtual Reality ProgramOther
Virtual Reality Program for improving hand function
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Traditional Treatment Program; Other: Virtual Reality Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start10 Jan 2024
- Primary completion30 Mar 2024
- Study completion8 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umm Al-Qura University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Hail
- Responsible party
- Principal investigator, Shamekh Mohamed El-Shamy, University of Hail
- Investigators
- Shamekh M Elshamy, Ph.D., Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398119
- Sponsor's protocol ID
- Hail University
- Status last verified
- Apr 2024
- First submitted
- 28 Apr 2024
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Visuomotor Training Using Pablo System on Hand Function in Children With Hemiplegic Cerebral Palsy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06398119
- Acronym / sponsor ID
- Hail University
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Umm Al-Qura UniversityUniversity, hospital or other
- Collaborators
- University of Hail
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 8 Apr 2024 (actual)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Treatment Arm | Active comparator | Other: Traditional Treatment Program, Other: Virtual Reality ProgramThe 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. |
| Virtual Reality Treatment Arm | Experimental | Other: Traditional Treatment Program, Other: Virtual Reality ProgramFor 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Treatment ProgramTraditional Treatment Program for improving hand function | Other | Traditional Treatment Arm, Virtual Reality Treatment Arm |
| Virtual Reality ProgramVirtual Reality Program for improving hand function | Other | Traditional Treatment Arm, Virtual Reality Treatment Arm |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shamekh M Elshamy, Ph.D. principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Treatment Program and Virtual Reality Program in people with Cerebral Palsy, run by Umm Al-Qura University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline spasticity degrees at 3 months (time frame: Baseline and 3 months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.