Cerebral PalsyNCT04769102
Seat Cushions Adaptations on Upper Extremity Function In Cerebral Palsy Children
A study testing seat cushions in people with Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
As the seating adaptations, ranging from simple to complex, standard and customized may facilitate optimal health and maximize functional participation despite limited postural control; the study will be conducted for determine the effect of contoured cushions as a seat adaptation on upper extremity function in… Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- seat cushions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 30 Aug 2022
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Their age ranged from three to six years old .
- Spasticity ranged from 1+ to 2 grade according to Modified Ashwarth Scale .
- All children should be able to sit on the adaptive seat while head is upright independently and hands are free; preliminary test by Gross Motor Functional Measurement (GMFM) scale ranged score from ( 21 to 25 ) in sitting domain.
Who cannot join
- Any child with the following criteria will be directly excluded from the evaluation for the consistency of the sample and statistically obtained results:
- Visual and/or auditory defects which interfere with upper extremity functions.
- Fixed deformity of one or both upper limbs which limit passive ROM in shoulder and elbow.
- Children with mixed type, dyskinetic or ataxic cerebral palsy are excluded.
- surgical intervention in both upper limbs or botulinum toxin injection in the last 6 months before the time of assessment .
- Any recent trauma of one or Both upper limbs.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Out Patient Clinic of Faculty of Physical Therapy Cairo Uni
Cairo, Giza- Beenelsarayat, 00202
Mohga M. Khalil, Msc., 00201227643588, dr_mohga_pt@yahoo.com
About this study
Official title: Effect of Different Seat Cushions Adaptation on Upper Extremity Function in Children With Spastic Cerebral Palsy
As the seating adaptations, ranging from simple to complex, standard and customized may facilitate optimal health and maximize functional participation despite limited postural control; the study will be conducted for determine the effect of contoured cushions as a seat adaptation on upper extremity function in children with spastic cerebral palsy and compare between the effect of flat cushion and contoured cushion in adaptive seating system on upper extremity function in children with spastic cerebral palsy.
Read the detailed description
As research continues to reveal the efficacy of ramped and contoured cushions on postural stability and alignment (Macdonald et al.,2015), it is likely that it will become accepted that such modifications will affect the UL functional level , mobility and rang of motion. Therefore, the purpose of this study was to examine the effect of contoured cushions as adaptive seating intervention on Upper extremity function in children with spastic cerebral palsy.
- Conditions
- Cerebral Palsy
- Being tested
- seat cushions
- Keywords
- seat cushions, upper extremity , cerebral palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
seat cushionsDevice
flat versus contoured customized seat cushions
| Study group | Role | What they receive |
|---|---|---|
| Spastic Cerebral Palsy | Experimental | spastic Cerebral palsy children will be adapted in adaptive seat with flat and then Contoured cushions while kinematic changes of upper limb reaching movement are monitored through video capture with kinovea 2D software motion analysis system. Receives: Device: seat cushions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angular kinematic changes in Upper extremity rang of motion in parallel to functional changes will be addressed while seat adaptations( flat and contoured cushions) will be applied for same participant.
angular kinematic changes ( by degrees) will be measured by kinovea 2D software
Measured: within 30 to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start1 Feb 2021
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Aug 2022 (estimated)
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamada Ahmed, Cairo University
- Investigators
- Faten H. Abd El Azeem, Phd, Study director, proffesor of peadiatric physical therapy Cairo Uni
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769102
- Sponsor's protocol ID
- P.T.REC/012/003018
- Status last verified
- Feb 2021
- First submitted
- 21 Feb 2021
- Last updated
- 24 Feb 2021
- Results posted
- No
- 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 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Seat Cushions Adaptation on Upper Extremity Function in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04769102
- Acronym / sponsor ID
- P.T.REC/012/003018
- Conditions
- Cerebral Palsy
- Keywords
- seat cushions, upper extremity , cerebral palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 24 Feb 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.
As the seating adaptations, ranging from simple to complex, standard and customized may facilitate optimal health and maximize functional participation despite limited postural control; the study will be conducted for determine the effect of contoured cushions as a seat adaptation on upper extremity function in children with spastic cerebral palsy and compare between the effect of flat cushion and contoured cushion in adaptive seating system on upper extremity function in children with spastic cerebral palsy.
Detailed description
As research continues to reveal the efficacy of ramped and contoured cushions on postural stability and alignment (Macdonald et al.,2015), it is likely that it will become accepted that such modifications will affect the UL functional level , mobility and rang of motion. Therefore, the purpose of this study was to examine the effect of contoured cushions as adaptive seating intervention on Upper extremity function in children with spastic cerebral palsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spastic Cerebral Palsy | Experimental | Device: seat cushionsspastic Cerebral palsy children will be adapted in adaptive seat with flat and then Contoured cushions while kinematic changes of upper limb reaching movement are monitored through video capture with kinovea 2D software motion analysis system. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Their age ranged from three to six years old .
- Spasticity ranged from 1+ to 2 grade according to Modified Ashwarth Scale .
- All children should be able to sit on the adaptive seat while head is upright independently and hands are free; preliminary test by Gross Motor Functional Measurement (GMFM) scale ranged score from ( 21 to 25 ) in sitting domain.
Key exclusion criteria (6 listed)
- Any child with the following criteria will be directly excluded from the evaluation for the consistency of the sample and statistically obtained results:
- Visual and/or auditory defects which interfere with upper extremity functions.
- Fixed deformity of one or both upper limbs which limit passive ROM in shoulder and elbow.
- Children with mixed type, dyskinetic or ataxic cerebral palsy are excluded.
- surgical intervention in both upper limbs or botulinum toxin injection in the last 6 months before the time of assessment .
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 |
|---|---|---|
| seat cushionsflat versus contoured customized seat cushions | Device | Spastic Cerebral Palsy |
Primary outcome
Angular kinematic changes in Upper extremity rang of motion in parallel to functional changes will be addressed while seat adaptations( flat and contoured cushions) will be applied for same participant.
Time frame: within 30 to 60 minutes
angular kinematic changes ( by degrees) will be measured by kinovea 2D software
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- 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.
Faten H. Abd El Azeem, Phd study director
proffesor of peadiatric physical therapy Cairo Uni
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing seat cushions in people with Cerebral Palsy, 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 24 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohga M. Khalil, Msc. (00201227643588, dr_mohga_pt@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angular kinematic changes in Upper extremity rang of motion in parallel to functional changes will be addressed while seat adaptations( flat and contoured cushions) will be applied for same participant. (time frame: within 30 to 60 minutes). 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 24 Feb 2021; AzTrials last refreshed its copy on 30 Oct 2026.