Hemiplegic Cerebral PalsyNCT04785417
Effect of Touch Screen Tablet on Fine Motor Functions
A study testing touch screen tablet in people with Hemiplegic Cerebral Palsy, run by Badr University at 1 site in Egypt.
Trial summary
the objective of this study to asses the effect of touch screen tablet on fine motor functions Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- touch screen tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 10 May 2023
- 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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- hemiplegia
- mid spasticity of upper limb
- able to follow instructions
Who cannot join
- fixed deformities visual or respiratory problem
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Touch Screen Tablet on Fine Motor Function un Children With Hemiparetic Cerebral
the objective of this study to asses the effect of touch screen tablet on fine motor functions
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- touch screen tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
touch screen tabletOther
traditional occupational therapy in addition to games on tablet
| Study group | Role | What they receive |
|---|---|---|
| CONTROL GROUP | No intervention | received conventional occupational therapy program |
| STUDY GROUP | Experimental | received conventional occupational therapy program in addition to using tablet Receives: Other: touch screen tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
pinch gauge
used to asses pinch strength
Measured: pre and post three month of intervention increase score indicate improvement
QUEST
to asses the fine motor function
Measured: pre and post three month of intervention increase score indicate improvement
nine hole pegboard test
used to asses the fine motor function
Measured: pre and post three month of intervention increase score indicate improvement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start1 Apr 2021
- Primary completion10 Oct 2022
- Study completion10 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hanaa mohsen, Badr University
- Investigators
- hanaa mohsen, Principal investigator, lecturer ,faculty of physical therapy, Badr universality in Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785417
- Sponsor's protocol ID
- HANA 6
- Status last verified
- May 2024
- First submitted
- 3 Mar 2021
- Last updated
- 10 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Touch Screen Tablet on Fine Motor Function un Children With Hemiparetic Cerebral
- ClinicalTrials.gov ID
- NCT04785417
- Acronym / sponsor ID
- HANA 6
- Conditions
- Hemiplegic Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 5 Mar 2021 (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 objective of this study to asses the effect of touch screen tablet on fine motor functions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL GROUP | No intervention | –received conventional occupational therapy program |
| STUDY GROUP | Experimental | Other: touch screen tabletreceived conventional occupational therapy program in addition to using tablet |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- hemiplegia
- mid spasticity of upper limb
- able to follow instructions
Key exclusion criteria (1 listed)
- fixed deformities visual or respiratory problem
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 |
|---|---|---|
| touch screen tablettraditional occupational therapy in addition to games on tablet | Other | STUDY GROUP |
Primary outcome
pinch gauge
Time frame: pre and post three month of intervention increase score indicate improvement
used to asses pinch strength
QUEST
Time frame: pre and post three month of intervention increase score indicate improvement
to asses the fine motor function
nine hole pegboard test
Time frame: pre and post three month of intervention increase score indicate improvement
used to asses the fine motor function
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 10 May 2024.
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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.
hanaa mohsen principal investigator
lecturer ,faculty of physical therapy, Badr universality in Cairo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing touch screen tablet in people with Hemiplegic Cerebral Palsy, run by Badr 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 3 inclusion and 1 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 10 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 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?
pinch gauge (time frame: pre and post three month of intervention increase score indicate improvement). The study lists 3 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 10 May 2024.