HemiplegiaNCT05596513
Motor Learning Approaches From Working on a Vertical Surface in Hemiplegic Children's Upper Limb Motor Skills
A study testing motor learning and occupational therapy and Motor Learning Approaches From Working on a Vertical Surface in people with Hemiplegia and Spastic, run by Omnya Samy Abdallah Ghoneim at 1 site in Egypt.
Trial summary
Working on a vertical surface is one of the best activities children can do to make themselves more successful in many areas as an infant which builds all those foundational skills required for the all-important task of handwriting. Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- Hemiplegia, Spastic
- What is being tested?
- motor learning and occupational therapy and Motor Learning Approaches From Working on a Vertical Surface
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Oct 2022to 28 Feb 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 5 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children diagnosed with spastic hemiplegic cerebral palsy
- Age 5 to 9 years
- Manual Ability Classification System (MACS)19 scores I, II.
- Children who can understand and cooperate with researcher's instructions
- Children with no visual or hearing impairment
Who cannot join
- Children with any surgical interference in the upper limb.
- Intellectual disability such that simple tasks could not be understood or executed.
- Inability to combine the study protocol with the regular school program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Intensive Motor Learning Approaches From Working on a Vertical Surface on Hemiplegic Children's Upper Limb Motor Skills
Working on a vertical surface is one of the best activities children can do to make themselves more successful in many areas as an infant which builds all those foundational skills required for the all-important task of handwriting.
Read the detailed description
Motor-learning approaches such as - constraint-induced movement therapy (CIMT) offer an array of sensorimotor experiences in a playful yet repetitive and intense fashion.
A stable shoulder girdle is the co-contraction of muscles around the scapula and shoulder joint.
Depending on the activity, vertical surfaces will have kids moving their arms frequently; reaching up, down, out and around. This supports extension of the arm and an opportunity to strengthen those muscles.
Vertical surfaces facilitate wrist extension. When the wrist is extended, the ring and pinky finger tend to naturally find their way into the palm creating a more optimal grasp pattern. A child is going to be able to execute more precise and legible work when using a functional tripod or quadrupod grasp.
- Conditions
- Hemiplegia, Spastic
- Being tested
- motor learning and occupational therapy, Motor Learning Approaches From Working on a Vertical Surface
- Keywords
- motor learning, vertical surface, hemiplegia, cerebral palsy
- Medical subject headings
- Hemiplegia, Muscle Spasticity, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motor learning and occupational therapyOther
- Constraint-induced movement therapy (CIMT)
- Hand-arm bimanual intensive training (HABIT)
Motor Learning Approaches From Working on a Vertical SurfaceOther
- Ball on wall, kneel to stand
- Kneel walk cross over
- Vertical playground puzzles and games
- Color on big boxes
- Fridge magnets
- Erasing a whiteboard or chalkboard
- Tactile feedback from textured walls
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | received intensive motor-learning approaches that focuses on training of the affected hand (motor-learning approaches such as - constraint-induced movement therapy (CIMT) and hand-arm bimanual intensive training (HABIT) provide an alternative). Receives: Other: motor learning and occupational therapy |
| study group | Experimental | received the intensive motor-learning approaches of the control group but from a vertical surface Receives: Other: Motor Learning Approaches From Working on a Vertical Surface |
What is being measured
The primary outcome is the main question the study is designed to answer.
QUEST
quality of upper extremity skills test (Only dissociated movement, grasp and weight bearing domains QUEST will be assessed).
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start30 Oct 2022
- Primary completion17 Jan 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies 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
- Model description
- received the intensive motor-learning approaches that focuses on training of the affected hand (motor-learning approaches such as - constraint-induced movement therapy (CIMT) and hand-arm bimanual intensive training (HABIT) of the control group but from a vertical surface
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omnya Samy Abdallah Ghoneim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Omnya Samy Abdallah Ghoneim, Badr University
- Investigators
- Omnya samy, PHD, Principal investigator, lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596513
- Sponsor's protocol ID
- P.T.REC/012/003981
- Status last verified
- Apr 2023
- First submitted
- 24 Oct 2022
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data is a private data for this research
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intensive Motor Learning Approaches From Working on a Vertical Surface on Hemiplegic Children's Upper Limb Motor Skills
- ClinicalTrials.gov ID
- NCT05596513
- Acronym / sponsor ID
- P.T.REC/012/003981
- Conditions
- Hemiplegia, Spastic
- Keywords
- motor learning, vertical surface, hemiplegia, cerebral palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Omnya Samy Abdallah GhoneimUniversity, hospital or other
- Study start
- 30 Oct 2022 (actual)
- Primary completion
- 17 Jan 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 27 Oct 2022 (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.
Working on a vertical surface is one of the best activities children can do to make themselves more successful in many areas as an infant which builds all those foundational skills required for the all-important task of handwriting.
Detailed description
Motor-learning approaches such as - constraint-induced movement therapy (CIMT) offer an array of sensorimotor experiences in a playful yet repetitive and intense fashion.
A stable shoulder girdle is the co-contraction of muscles around the scapula and shoulder joint.
Depending on the activity, vertical surfaces will have kids moving their arms frequently; reaching up, down, out and around. This supports extension of the arm and an opportunity to strengthen those muscles.
Vertical surfaces facilitate wrist extension. When the wrist is extended, the ring and pinky finger tend to naturally find their way into the palm creating a more optimal grasp pattern. A child is going to be able to execute more precise and legible work when using a functional tripod or quadrupod grasp.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- received the intensive motor-learning approaches that focuses on training of the affected hand (motor-learning approaches such as - constraint-induced movement therapy (CIMT) and hand-arm bimanual intensive training (HABIT) of the control group but from a vertical surface
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: motor learning and occupational therapyreceived intensive motor-learning approaches that focuses on training of the affected hand (motor-learning approaches such as - constraint-induced movement therapy (CIMT) and hand-arm bimanual intensive training (HABIT) provide an alternative). |
| study group | Experimental | Other: Motor Learning Approaches From Working on a Vertical Surfacereceived the intensive motor-learning approaches of the control group but from a vertical surface |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children diagnosed with spastic hemiplegic cerebral palsy
- Age 5 to 9 years
- Manual Ability Classification System (MACS)19 scores I, II.
- Children who can understand and cooperate with researcher's instructions
- Children with no visual or hearing impairment
Key exclusion criteria (3 listed)
- Children with any surgical interference in the upper limb.
- Intellectual disability such that simple tasks could not be understood or executed.
- Inability to combine the study protocol with the regular school program
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 |
|---|---|---|
| motor learning and occupational therapy1. Constraint-induced movement therapy (CIMT) 2. Hand-arm bimanual intensive training (HABIT) | Other | control group |
| Motor Learning Approaches From Working on a Vertical Surface1. Ball on wall, kneel to stand 2. Kneel walk cross over 3. Vertical playground puzzles and games 4. Color on big boxes 5. Fridge magnets 6. Erasing a whiteboard or chalkboard 7. Tactile feedback from textured walls | Other | study group |
Primary outcome
QUEST
Time frame: 3 month
quality of upper extremity skills test (Only dissociated movement, grasp and weight bearing domains QUEST will be assessed).
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 11 Apr 2023.
- Individual participant dataSharing planned: No. individual participant data is a private data for this research
Related trials for Hemiplegia
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Studies of the Variable Phenotypic Presentations of Rapid-Onset Dystonia Parkinsonism and Other Movement Disorders
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Functional Benefits of Multisite Upper Limb Surgery in Children With Unilateral Cerebral Palsy (RETRO-CHIRc)
Cerebral Palsy, Hemiplegia
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Post-Stroke Apraxia, Motor Function, Balance, and Gait
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Ideomotor Apraxia and Robotic Gait Rehabilitation Outcomes After Stroke
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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.
Omnya samy, PHD principal investigator
lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motor learning and occupational therapy and Motor Learning Approaches From Working on a Vertical Surface in people with Hemiplegia and Spastic, run by Omnya Samy Abdallah Ghoneim 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 3 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 11 Apr 2023. 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?
QUEST (time frame: 3 month). 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 11 Apr 2023.