Cerebral PalsyNCT05751122
Effects of Dynamic Flex Cast With Neurodevelopmental Treatment on Gross Motor Functions in Cerebral Palsy
A study testing Dynamic flex cast with neurodevelopmental treatment and Rigid Ankle foot Orthosis with neurodevelopmental treatment in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study aims to determine the effects of dynamic flex cast with neurodevelopmental treatment on gross motor functions and gait in children with cerebral palsy. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Dynamic flex cast with neurodevelopmental treatment and Rigid Ankle foot Orthosis with neurodevelopmental treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Feb 2023to 15 Jul 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 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with cerebral palsy
- Age 3-8 years
- Spastic diplegic/ hemiplegic CP
- Ankle dorsiflexion 5-10 degrees
- GMFCS level 1-3
- Modified Ashworth's scale level 1+ - 3
Who cannot join
- Congenital foot deformities
- Cognitive impairments
- Secondary orthopedic, auditory and severe visual impairments
- Unwilling patients or parents
- Recent surgical interventions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Dynamic Flex Cast With Neurodevelopmental Treatment on Gross Motor Functions in Children With Cerebral Palsy
The study aims to determine the effects of dynamic flex cast with neurodevelopmental treatment on gross motor functions and gait in children with cerebral palsy.
Read the detailed description
The study aims to determine the effects of dynamic flex cast with neurodevelopmental treatment on gross motor functions and gait in children with cerebral palsy. Combination of Dynamic flex cast with neurodevelopmental treatment will be a novel potential treatment to improve gross motor functions in cerebral palsy. We shall try to fill the gaps of previous studies. It will help in facilitating children to perform their activities, restoring normal ranges and treatment of spasticity in cerebral palsy.
- Conditions
- Cerebral Palsy
- Being tested
- Dynamic flex cast with neurodevelopmental treatment, Rigid Ankle foot Orthosis with neurodevelopmental treatment
- Keywords
- Ankle joint, Cerebral Palsy, Spasticity, Dynamic cast
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic flex cast with neurodevelopmental treatmentOther
Neurodevelopmental therapy in combination with dynamic flex cast to treat experimental group.
Three times a week, 1 hour session per day.
Dynamic flex casting is casting which manipulate bone alignment and maintains range of motion or sustained stretch. Casting will be changed weekly for 3 months.
Neuro developmental approach is individualized treatment which is attuned to each child's specific problems, aims and goals.
Key elements in NDT are: facilitation (using sensory inputs to improve motor performance), management of compensatory motor behavior, and an overall management strategy (a 24-hour interdisciplinary management approach) NDT involves task specific postures and movements.
Rigid Ankle foot Orthosis with neurodevelopmental treatmentOther
Rigid ankle foot orthosis will be applied to ankle joint at the start of intervention.
Neurodevelopmental treatment will be applied to both groups with protocol; Three times a week, 1 hour session per day.
Assessment on 1st day,6th week and 12th week
| Study group | Role | What they receive |
|---|---|---|
| Dynamic flex cast with neurodevelopmental Group | Experimental | Dynamic flex cast with neurodevelopmental treatment Receives: Other: Dynamic flex cast with neurodevelopmental treatment |
| Rigid Ankle foot Orthosis with neurodevelopmental Group | Active comparator | Rigid Ankle foot Orthosis with neurodevelopmental treatment Receives: Other: Rigid Ankle foot Orthosis with neurodevelopmental treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure-88
The original GMFM has 88 items each scored on a 4-point ordinal scale of 0 to 3, where 0 indicates that the child does not initiate the task; 1 indicates that the child initiates the task (completes < 10% activity); 2 indicates that the child partially completes the task (completes from 10 to 99% of activity); 3 indicates that the child completes the task (100%); and NT indicates that the child was not tested. The 88 items are grouped into five dimensions: 1) lying and rolling, 2) sitting, 3) crawling and kneeling, 4) standing, and 5) walking, running and jumping. Reliability with intraclass correlation coeffcient greater than .98 with 0.965--.994 95% confidence interval.
Measured: 12 weeks
Clinical Gait Assessment Scale
It is used to assess gait deviation. Temporal distance factors including velocity, cadence, stride length, stride width will be assessed.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start25 Feb 2023
- Primary completion15 Jul 2023
- Study completion15 Jul 2023
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 Riphah International 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abrish Abbasi, MS-NMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751122
- Sponsor's protocol ID
- Nafisa Gul
- Status last verified
- Jul 2023
- First submitted
- 20 Feb 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- 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 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dynamic Flex Cast With Neurodevelopmental Treatment on Gross Motor Functions in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05751122
- Acronym / sponsor ID
- Nafisa Gul
- Conditions
- Cerebral Palsy
- Keywords
- Ankle joint, Cerebral Palsy, Spasticity, Dynamic cast
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Feb 2023 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 2 Mar 2023 (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 study aims to determine the effects of dynamic flex cast with neurodevelopmental treatment on gross motor functions and gait in children with cerebral palsy.
Detailed description
The study aims to determine the effects of dynamic flex cast with neurodevelopmental treatment on gross motor functions and gait in children with cerebral palsy. Combination of Dynamic flex cast with neurodevelopmental treatment will be a novel potential treatment to improve gross motor functions in cerebral palsy. We shall try to fill the gaps of previous studies. It will help in facilitating children to perform their activities, restoring normal ranges and treatment of spasticity in cerebral palsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynamic flex cast with neurodevelopmental Group | Experimental | Other: Dynamic flex cast with neurodevelopmental treatmentDynamic flex cast with neurodevelopmental treatment |
| Rigid Ankle foot Orthosis with neurodevelopmental Group | Active comparator | Other: Rigid Ankle foot Orthosis with neurodevelopmental treatmentRigid Ankle foot Orthosis with neurodevelopmental treatment |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children with cerebral palsy
- Age 3-8 years
- Spastic diplegic/ hemiplegic CP
- Ankle dorsiflexion 5-10 degrees
- GMFCS level 1-3
Key exclusion criteria (5 listed)
- Congenital foot deformities
- Cognitive impairments
- Secondary orthopedic, auditory and severe visual impairments
- Unwilling patients or parents
- Recent surgical interventions
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 |
|---|---|---|
| Dynamic flex cast with neurodevelopmental treatmentNeurodevelopmental therapy in combination with dynamic flex cast to treat experimental group. Three times a week, 1 hour session per day. Dynamic flex casting is casting which manipulate bone alignment and maintains range of motion or sustained stretch. Casting will be changed weekly for 3 months. Neuro developmental approach is individualized treatment which is attuned to each child's specific problems, aims and goals. Key elements in NDT are: facilitation (using sensory inputs to improve motor performance), management of compensatory motor behavior, and an overall management strategy (a 24-hour interdisciplinary management approach) NDT involves task specific postures and movements. | Other | Dynamic flex cast with neurodevelopmental Group |
| Rigid Ankle foot Orthosis with neurodevelopmental treatmentRigid ankle foot orthosis will be applied to ankle joint at the start of intervention. Neurodevelopmental treatment will be applied to both groups with protocol; Three times a week, 1 hour session per day. Assessment on 1st day,6th week and 12th week | Other | Rigid Ankle foot Orthosis with neurodevelopmental Group |
Primary outcome
Gross Motor Function Measure-88
Time frame: 12 weeks
The original GMFM has 88 items each scored on a 4-point ordinal scale of 0 to 3, where 0 indicates that the child does not initiate the task; 1 indicates that the child initiates the task (completes < 10% activity); 2 indicates that the child partially completes the task (completes from 10 to 99% of activity); 3 indicates that the child completes the task (100%); and NT indicates that the child was not tested. The 88 items are grouped into five dimensions: 1) lying and rolling, 2) sitting, 3) crawling and kneeling, 4) standing, and 5) walking, running and jumping. Reliability with intraclass correlation coeffcient greater than .98 with 0.965--.994 95% confidence interval.
Clinical Gait Assessment Scale
Time frame: 12 weeks
It is used to assess gait deviation. Temporal distance factors including velocity, cadence, stride length, stride width 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 25 Jul 2023.
- 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.
Abrish Abbasi, MS-NMPT principal investigator
Riphah International 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 Dynamic flex cast with neurodevelopmental treatment and Rigid Ankle foot Orthosis with neurodevelopmental treatment in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
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 6 inclusion and 5 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 25 Jul 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 Pakistan. 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?
Gross Motor Function Measure-88 (time frame: 12 weeks). The study lists 2 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 25 Jul 2023.