Cerebral Palsy Spastic DiplegiaNCT06291974
Ankle Foot Orthosis on Muscle Activity in Cerebral Palsy
An observational study of Cerebral Palsy Spastic Diplegia, run by Delta University for Science and Technology.
Trial summary
To compare the effect of solid ankle foot orthosis and ground reaction foot orthosis on the muscle activity in children with spastic diplegic cerebral palsy (Gross Motor Functional Classification Scale III). Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy Spastic Diplegia
- What is being tested?
- electromyography
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2024to 30 Nov 2024
- Phase
- Observational
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: children diagnosed with cp spastic diplegia with postural instability will represent the sample of this study. They will be selected from the clinic of faculty of physical therapy, delta university and my private clinic.
Who may be able to join
- Spasticity level II in lower limb muscles according to Modified Ashworth Scale.
- Able to follow order.
- Aged from 6 to 12 years old.
Who cannot join
- Visual or obvious detected vestibular sensory disorders or cerebellar disease.
- Botox injection in the last 6 months.
- Cognitive deficits or disturbed conscious level.
About this study
Official title: Efficacy of Solid Versus Ground Reaction Ankle Foot Orthosis on Muscular Activity in Children With Spastic Diplegic in Cerebral Palsy
To compare the effect of solid ankle foot orthosis and ground reaction foot orthosis on the muscle activity in children with spastic diplegic cerebral palsy (Gross Motor Functional Classification Scale III).
Read the detailed description
Few studies have examined muscular activity via electromyography (EMG) during quiet standing in children with cp.
A few studies have examined the benefits of ground reaction ankle foot orthosis, showing that it could effectively reduce or eliminate the crouch position in children with spastic cerebral palsy however little is known about the benefits of GRAFOs on postural control mechanisms in static standing in children with CP.
Previous Studies suggested that appropriate tuning of ankle foot orthosis properties may reduce muscle demand for children with CP.
So, this study may be a guide in management of postural instability in children with spastic diplegic cerebral palsy in standing position.
- Conditions
- Cerebral Palsy Spastic Diplegia
- Being tested
- electromyography
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electromyographyDiagnostic test
Surface Electromyography (SEMG) is a measurement of the electrical activity in muscles as a byproduct of contraction.
It is the summation of action potentials from the muscle fibers under the electrodes placed on the skin
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle activity by Electromyography device
activity of gastrocnemius ad tibialis anterior muscle by Electromyography device
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start15 Mar 2024 (estimated)
- Primary completion15 Oct 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy Spastic DiplegiaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291974
- Sponsor's protocol ID
- delta2024
- Status last verified
- Feb 2024
- First submitted
- 20 Feb 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Solid Versus Ground Reaction Ankle Foot Orthosis on Muscular Activity in Children With Spastic Diplegic in Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06291974
- Acronym / sponsor ID
- delta2024
- Conditions
- Cerebral Palsy Spastic Diplegia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- 15 Oct 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 4 Mar 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.
To compare the effect of solid ankle foot orthosis and ground reaction foot orthosis on the muscle activity in children with spastic diplegic cerebral palsy (Gross Motor Functional Classification Scale III).
Detailed description
Few studies have examined muscular activity via electromyography (EMG) during quiet standing in children with cp.
A few studies have examined the benefits of ground reaction ankle foot orthosis, showing that it could effectively reduce or eliminate the crouch position in children with spastic cerebral palsy however little is known about the benefits of GRAFOs on postural control mechanisms in static standing in children with CP.
Previous Studies suggested that appropriate tuning of ankle foot orthosis properties may reduce muscle demand for children with CP.
So, this study may be a guide in management of postural instability in children with spastic diplegic cerebral palsy in standing position.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children diagnosed with cp spastic diplegia with postural instability will represent the sample of this study. They will be selected from the clinic of faculty of physical therapy, delta university and my private clinic.
Key inclusion criteria (3 listed)
- Spasticity level II in lower limb muscles according to Modified Ashworth Scale.
- Able to follow order.
- Aged from 6 to 12 years old.
Key exclusion criteria (3 listed)
- Visual or obvious detected vestibular sensory disorders or cerebellar disease.
- Botox injection in the last 6 months.
- Cognitive deficits or disturbed conscious level.
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 |
|---|---|---|
| electromyographySurface Electromyography (SEMG) is a measurement of the electrical activity in muscles as a byproduct of contraction. It is the summation of action potentials from the muscle fibers under the electrodes placed on the skin | Diagnostic test | – |
Primary outcome
muscle activity by Electromyography device
Time frame: up to 12 months
activity of gastrocnemius ad tibialis anterior muscle by Electromyography device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy Spastic Diplegia, run by Delta University for Science and Technology.
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 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: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
muscle activity by Electromyography device (time frame: up to 12 months). 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 7 Mar 2024.