Physical DisabilityNCT04679779
Virtual Reality in Children With Hemiparesis
A study testing designed occupational therapy program and Wii virtual reality games in people with Physical Disability, run by Cairo University at 1 site in Egypt.
Trial summary
children with cerebral palsy have impaired selective motor control and upper limb functions that affect their performance Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Physical Disability
- What is being tested?
- designed occupational therapy program and Wii virtual reality games
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 15 Feb 2021
- 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 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- - Age between 7 and 11 years
- spasticity grade of 1+ or 2 on MAS
- level I and II on GMFCS
- level II and III on MACS
- Being able to cooperate and being motivated
Who cannot join
- visual or auditory problems Severe spasticity (an Ashworth spasticity score of 4 in any upper or lower extremities) Severe mental retardation surgeries for spasticity within the past 12 months, toxin injection within the past six months.
- Structural or fixed soft tissue deformities in the affected upper extremity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Virtual Reality on Selective Motor Control and Upper Limb Functions in Children With Hemiparesis: A Pilot Study
children with cerebral palsy have impaired selective motor control and upper limb functions that affect their performance
Read the detailed description
Twenty volunteer children diagnosed with hemiparetic cerebral palsy will be recruited from national institute of neuromotor system. they will be randomly assigned to intervention and control group.
- Conditions
- Physical Disability
- Being tested
- designed occupational therapy program, Wii virtual reality games
- Keywords
- cerebral palsy, selective motor control, upper limb coordination, virtual reality
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
designed occupational therapy programOther
Exercises facilitating hand skill patterns will include basic reach, grasp, carry and release and the more complex skills of in-hand manipulation and bilateral hand use.
Wii virtual reality gamesOther
- Bowling
- Frisbee
- Basketball
- Boxing
| Study group | Role | What they receive |
|---|---|---|
| control group | Experimental | receive occupational therapy program Receives: Other: designed occupational therapy program |
| study group | Experimental | receive wii virtual reality Receives: Other: Wii virtual reality games |
What is being measured
The primary outcome is the main question the study is designed to answer.
Selective voluntary motor control of upper extremity
Test of Arm Selective Control will be used to assess selective voluntary motor control of upper extremityIt was developed to quantify the extent to which children with cerebral palsy have selective voluntary motor control. It will be used to assess movement of shoulder, elbow, forearm, wrist, finger and thumb by using simple tools for grasp items from two starting sitting positions
Measured: 6 weeks
Secondary outcomes (2)
Hand grip strength
it will be assessed by hand held dynamometer
Measured: 6 weeks
- Upper limb function
it will be assessed by Bruinink-Oseretsky test for motor proficiency subset 7 of upper limb coordination
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start1 Dec 2020
- Primary completion1 Feb 2021
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical DisabilityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- Control grouprecivedvDesigned occupational therapy programe including Exercises facilitating hand skill patterns will include basic reach, grasp, carry and release and the more complex skills of in-hand manipulation and bilateral hand use. • study group will recieve Wii virtual reality games 1. Bowling 2. Frisbee 3. Basketball 4. Boxing
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ebrahem Fayed, Cairo University
- Investigators
- hoda eltalawy, professor, Study chair, Cairo Universityshorouk elshennawy, professor, Study director, Cairo Universityamira mahmoud, phd, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679779
- Sponsor's protocol ID
- virtual reality
- Status last verified
- Jan 2021
- First submitted
- 17 Dec 2020
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality on Selective Motor Control and Upper Limb Functions in Children With Hemiparesis: A Pilot Study
- ClinicalTrials.gov ID
- NCT04679779
- Acronym / sponsor ID
- virtual reality
- Conditions
- Physical Disability
- Keywords
- cerebral palsy, selective motor control, upper limb coordination, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 22 Dec 2020 (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.
children with cerebral palsy have impaired selective motor control and upper limb functions that affect their performance
Detailed description
Twenty volunteer children diagnosed with hemiparetic cerebral palsy will be recruited from national institute of neuromotor system. they will be randomly assigned to intervention and control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Control grouprecivedvDesigned occupational therapy programe including Exercises facilitating hand skill patterns will include basic reach, grasp, carry and release and the more complex skills of in-hand manipulation and bilateral hand use. • study group will recieve Wii virtual reality games 1. Bowling 2. Frisbee 3. Basketball 4. Boxing
| Arm | Type | Receives |
|---|---|---|
| control group | Experimental | Other: designed occupational therapy programreceive occupational therapy program |
| study group | Experimental | Other: Wii virtual reality gamesreceive wii virtual reality |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- - Age between 7 and 11 years
- spasticity grade of 1+ or 2 on MAS
- level I and II on GMFCS
- level II and III on MACS
- Being able to cooperate and being motivated
Key exclusion criteria (2 listed)
- visual or auditory problems Severe spasticity (an Ashworth spasticity score of 4 in any upper or lower extremities) Severe mental retardation surgeries for spasticity within the past 12 months, toxin injection within the past six months.
- Structural or fixed soft tissue deformities in the affected upper extremity
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 |
|---|---|---|
| designed occupational therapy programExercises facilitating hand skill patterns will include basic reach, grasp, carry and release and the more complex skills of in-hand manipulation and bilateral hand use. | Other | control group |
| Wii virtual reality games1. Bowling 2. Frisbee 3. Basketball 4. Boxing | Other | study group |
Primary outcome
Selective voluntary motor control of upper extremity
Time frame: 6 weeks
Test of Arm Selective Control will be used to assess selective voluntary motor control of upper extremityIt was developed to quantify the extent to which children with cerebral palsy have selective voluntary motor control. It will be used to assess movement of shoulder, elbow, forearm, wrist, finger and thumb by using simple tools for grasp items from two starting sitting positions
2 secondary outcomes
Hand grip strength
Time frame: 6 weeks
- Upper limb function
Time frame: 6 weeks
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 23 Feb 2021.
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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.
hoda eltalawy, professor study chair
Cairo University
shorouk elshennawy, professor study director
Cairo University
amira mahmoud, phd study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing designed occupational therapy program and Wii virtual reality games in people with Physical Disability, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 2 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 23 Feb 2021. 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 Egypt. 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?
Selective voluntary motor control of upper extremity (time frame: 6 weeks). 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 23 Feb 2021.