Diplegic Cerebral PalsyNCT06813599
The Best Intervention to Improve Gait Pattern in Children with Spastic Diplegic Cerebral Palsy
A study testing Neurodevelopmental Technique on Gait Pattern in Children With Spastic Diplegic Cerebral Palsy and Motor Planning Exercises on Gait Pattern in Children With Spastic Diplegic Cerebral Palsy in people with Diplegic Cerebral Palsy, run by Kafrelsheikh University at 2 sites in Egypt.
Trial summary
Cerebral palsy is the most common disability in childhood, is a devastating non-progressive ailment of the infants' brain with lifelong sequelae (e.g., spastic paresis, chronic pain, inability to walk, intellectual disability, behavioral disorders) for which there is no cure at present. Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Diplegic Cerebral Palsy
- What is being tested?
- Neurodevelopmental Technique on Gait Pattern in Children With Spastic Diplegic Cerebral Palsy and Motor Planning Exercises on Gait Pattern in Children With Spastic Diplegic Cerebral Palsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Mar 2025to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parents/legals representatives consenting to their child's participation
- Diagnosis of cerebral palsy
- Ages 3-14 years - Cooperative behavior
- Their grade of spasticity will be from 1 to 2 according to Modified Ashworth scale
- They will be on Level I and II according to Gross Motor Functional Classification System
- The child will be able to follow verbal commands and instructions.
Show all 14Show fewer
- Exclusion Criteria: The children will be excluded if they have one of the following:
- Previous neurological or orthopedic surgery in the lower extremities.
- Botox injection in the lower extremities in the past 6 months.
- Fixed deformity in the joints of lower limb.
- Severe hearing and visual problems.
- Different diagnosis than cerebral palsy.
- Inability to "walk freely or with a mobility aid (GMFCS Level IV or V)" .
- Irregular attendance at assessments or therapy sessions.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
ahmed ME sharaf contact
Egypt2 sites
Kafr Ash Shaykh university
Kafr ash Shaykh
ahmed mohamed, 2001029881160, a38215537@gmail.com
Kafr Ash Shaykh University
Kafr ash Shaykh
About this study
Official title: Effect of Motor Planning Exercises Versus Neurodevelopmental Technique on Gait Pattern in Children with Spastic Diplegic Cerebral Palsy
Cerebral palsy is the most common disability in childhood, is a devastating non-progressive ailment of the infants' brain with lifelong sequelae (e.g., spastic paresis, chronic pain, inability to walk, intellectual disability, behavioral disorders) for which there is no cure at present. Cerebral palsy has different causes such as perinatal asphyxia, stroke and central nervous system CNS infection.
Cerebral palsy may have several associated comorbidities, including epilepsy, musculoskeletal problems, intellectual disability, feeding difficulties, visual abnormalities, hearing abnormalities, and communication difficulties. There are different classifications of CP primarily based on motor type and topography one of them is diplegic CP, lower limbs are more seriously affected than the upper limb at times, patients have toe strolling because of a dorsiflexion problem of the foot and expansion in the tone of the lower leg. In serious cases, there is a flexion of the hips, knees and elbows, and when the child is held upward, the firmness of the lower furthest points is generally articulated and tightness of the adductor muscles of the lower legs cause scissoring of lower limits.
Read more
Neurodevelopmental therapy NDT is a popular approach to rehabilitation for people with cerebral palsy. It focuses on improving movement by analyzing how the body moves, understanding the relationship between posture and movement, and using sensory information to guide motor control. NDT therapists often use techniques like handling to facilitate movement and train people to use more typical motor patterns. While NDT has been widely used, there's ongoing debate about its effectiveness compared to other approaches, and its specific practices can vary across different countries and settings.
Motor planning is defined as either an explicit decision-making or implicit process that takes into consideration both the goal and the constraints of the desired movement . This process is thought to rely on a feedforward internal model based on action simulation . Before a motor command is sent, the system briefly perceives the environmental cues to anticipate the realization of an adapted movement . Through the representation of the sensorimotor associations learned from past experiences, a prediction of the sensory consequences of the action is made . This step appears before action initiation and is believed to be based on the copy of the motor command for a subset of tasks .
Motor planning is a large concept encompassing terms such as anticipatory control, motor preparation, and motor programming, with the terminology changing over time and varying by field of study.
Motor Planning Organization of Motor Actions Motor planning is the ability to automatically organize a motor act so that it can be performed or implemented. This involves the internal process of organizing one's motor actions, without consciously planning out the action is believed to be largely dependent on tactile proprioceptive sensory inputs, although visual perceptual and visual spatial skills are also often associated with this area of function. Most often, problems in motor planning are reflected in difficulties in planning body movements.
Read the detailed description
CP is a group of permanent disorders of the development of movement and posture, causing activity limitations that are attributed to non-progressive disturbances that occurred in the developing fetal or infant brain.
CP describes a group of permanent disorders of movement and posture, causing activity limitation, that are attributed to non progressive disturbances that occurred in the developing fetal or immature brain. The motor disorders of CP are often accompanied by disturbances of sensation, perception, cognition, communication, and behavior, by epilepsy, and by secondary musculoskeletal problems.
Spastic CP is described by which parts of the body are affected:
Spastic diplegia In this type of CP, spasticity is mainly in the legs, with the arms less affected or not affected at all. People with spastic diplegia might have difficulty walking because tight hip and leg muscles cause their legs to pull together, turn inward, and cross at the knees also known as scissoring.
Spastic hemiplegia Hemiplegia affects only one side of body, usually the arm is more affected than the leg.
Spastic quadriplegia Spastic quadriplegia is the most severe form of spastic CP and affects all four limbs, the trunk, and the face. People with spastic quadriplegia usually cannot walk and often have other developmental disabilities such as intellectual disability, seizures, or problems with vision, hearing or speech.
Diplegic cerebral palsy is one of the most common frequent symptoms in CP children. Those with SD usually have greater lower extremity than upper extremity involvement, the most common effects are stiff or tight muscles, lack of muscle coordination when performing voluntary movements, leg dragging, hyper myotonia of both lower extremities, talipes varus and inflexion, walking on the toes and crouched gait Neurodevelopmental treatment NDT is a problem-solving method for assessing and treating the functional limitations of individuals with CP. The NDT strategy enhances posture and function used in day-to-day context in children with CP
Is a therapeutic handling used to aid the child's movement, to redirect unwanted and ineffective movements, and to assist the child in learning patterns of movement that are more efficient and will lead to improved function. NDT should be playful and collaborative with shared control of the sessions between the client and the clinician. The NDT approach is functional, fun, efficient, effective, and collaborative with positive effects noted through the ages. While recognizing their personal improvements, clients enjoy their sessions and willingly return to improve their function and participation in life.
Motor planning:
Motor planning is defined as either an explicit i.e., decision-making or implicit process that takes into consideration both the goal and the constraints of the desired movement . This process is thought to rely on a feedforward internal model based on action simulation . Before a motor command is sent, the system briefly perceives the environmental cues to anticipate the realization of an adapted movement . Through the representation of the sensorimotor associations learned from past experiences, a prediction of the sensory consequences of the action is made. This step appears before action initiation and is believed to be based on the copy of the motor command for a subset of tasks . Motor planning is a large concept encompassing terms such as anticipatory control, motor preparation, and motor programming, with the terminology changing over time and varying by field of study.
- Conditions
- Diplegic Cerebral Palsy
- Being tested
- Neurodevelopmental Technique on Gait Pattern in Children With Spastic Diplegic Cerebral Palsy, Motor Planning Exercises on Gait Pattern in Children With Spastic Diplegic Cerebral Palsy
- Keywords
- CP, Diaplegic, motor planning, Gait pattern
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurodevelopmental Technique on Gait Pattern in Children With Spastic Diplegic Cerebral PalsyOther
Each child of group A received a designed NDT program, attending three sessions per week for two consecutive months. The internationally recognized neurodevelopmental therapy (NDT) intervention will be used, consisting chiefly of three components:
- Exercise training: the therapist is goal-oriented and works with the child to make a family exercise plan. The plan is developed based on specific activities of the children in the family. The plan is designed step by step, and all tasks allow the child to reach a functional goal. Having set an exercise target, the child is able to achieve the goal as his/her exercise ability increases. Subsequently, the difficulty level of the task is increased or the environment altered, so the infant continues to face challenges to exercise ability. In the process of implementing the training plan, the therapist should pay attention to the degree of completion and quality of child movements, making corrections and offering guidance twice weekly.
Motor Planning Exercises on Gait Pattern in Children With Spastic Diplegic Cerebral PalsyOther
Each child of group B will receive a designed motor planning program, attending three sessions per week for two consecutive months. Practicing skills will help children with poor motor planning ability become more confident. There are many things we can do to help children improve their motor planning. Using simple language, Thinking about all the different steps to complete a sequence of steps can be difficult for children with motor planning difficulties so we should keep language simple to help them better understand what they need to do to complete a task.
Breaking new skills down into smaller steps, Guiding the child through a task by providing one instruction at a time. This will help them to better follow instructions and reduce anxiety over learning a new skill. Starting with the simplest movement first, Practice the individual movements that make up a task, gradually increasing the degree of difficulty as your child gains confidence in the simpler movements.
| Study group | Role | What they receive |
|---|---|---|
| group (A) | Experimental | Each child of group A received a designed NDT program, attending three sessions per week for two consecutive months. The internationally recognized neurodevelopmental therapy (NDT) intervention will be used, consisting chiefly of three components. Receives: Other: Neurodevelopmental Technique on Gait Pattern in Children With Spastic Diplegic Cerebral Palsy |
| group (B) | Experimental | Each child of group B will receive a designed motor planning program, attending three sessions per week for two consecutive months.
Practicing skills will help children with poor motor planning ability become more confident. There are many things we can do to help children improve their motor planning. Receives: Other: Motor Planning Exercises on Gait Pattern in Children With Spastic Diplegic Cerebral Palsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the progress of the COP throughout the foot support phase .
GAIT LINE IN DYNAMIC ANALYSIS evaluate the progress of the COP throughout the foot support phase.
Measured: after 2 months of treatment
change of space-time parameters of walking
GAIT CYCLE IN DYNAMIC ANALYSIS change of space-time parameters of walking
Measured: after 2 months of treatment
change of pressure distribution
Visualization of the footprint to analyze the change of pressure distribution
Measured: after 2 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion28 May 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diplegic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Model description
- intervention study model parallel assignment the study will include thirty children diagnosed as spastic diplegic cerebral palsy from both sexes (age 6-10 years old ) meeting the inclusion criteria, subjects divided into 2 randomized subgroups group A will receive a designed NDT program, attending three sessions per week for two consecutive months, and group B will receive a designed motor planning program, attending three sessions per week for two consecutive months.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Elsayed Sharaf, Kafrelsheikh University
- Investigators
- Mohamed B ibrahim, assist .prof, Study chair, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813599
- Sponsor's protocol ID
- KFS1RB200-391
- Status last verified
- Feb 2025
- First submitted
- 28 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Motor Planning Exercises Versus Neurodevelopmental Technique on Gait Pattern in Children with Spastic Diplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06813599
- Acronym / sponsor ID
- KFS1RB200-391
- Conditions
- Diplegic Cerebral Palsy
- Keywords
- CP, Diaplegic, motor planning, Gait pattern
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 28 May 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 7 Feb 2025 (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.
Cerebral palsy is the most common disability in childhood, is a devastating non-progressive ailment of the infants' brain with lifelong sequelae (e.g., spastic paresis, chronic pain, inability to walk, intellectual disability, behavioral disorders) for which there is no cure at present. Cerebral palsy has different causes such as perinatal asphyxia, stroke and central nervous system CNS infection.
Cerebral palsy may have several associated comorbidities, including epilepsy, musculoskeletal problems, intellectual disability, feeding difficulties, visual abnormalities, hearing abnormalities, and communication difficulties. There are different classifications of CP primarily based on motor type and topography one of them is diplegic CP, lower limbs are more seriously affected than the upper limb at times, patients have toe strolling because of a dorsiflexion problem of the foot and expansion in the tone of the lower leg. In serious cases, there is a flexion of the hips, knees and elbows, and when the child is held upward, the firmness of the lower furthest points is generally articulated and tightness of the adductor muscles of the lower legs cause scissoring of lower limits.
Neurodevelopmental therapy NDT is a popular approach to rehabilitation for people with cerebral palsy. It focuses on improving movement by analyzing how the body moves, understanding the relationship between posture and movement, and using sensory information to guide motor control. NDT therapists often use techniques like handling to facilitate movement and train people to use more typical motor patterns. While NDT has been widely used, there's ongoing debate about its effectiveness compared to other approaches, and its specific practices can vary across different countries and settings.
Motor planning is defined as either an explicit decision-making or implicit process that takes into consideration both the goal and the constraints of the desired movement . This process is thought to rely on a feedforward internal model based on action simulation . Before a motor command is sent, the system briefly perceives the environmental cues to anticipate the realization of an adapted movement . Through the representation of the sensorimotor associations learned from past experiences, a prediction of the sensory consequences of the action is made . This step appears before action initiation and is believed to be based on the copy of the motor command for a subset of tasks .
Motor planning is a large concept encompassing terms such as anticipatory control, motor preparation, and motor programming, with the terminology changing over time and varying by field of study.
Motor Planning Organization of Motor Actions Motor planning is the ability to automatically organize a motor act so that it can be performed or implemented. This involves the internal process of organizing one's motor actions, without consciously planning out the action is believed to be largely dependent on tactile proprioceptive sensory inputs, although visual perceptual and visual spatial skills are also often associated with this area of function. Most often, problems in motor planning are reflected in difficulties in planning body movements.
Detailed description
CP is a group of permanent disorders of the development of movement and posture, causing activity limitations that are attributed to non-progressive disturbances that occurred in the developing fetal or infant brain.
CP describes a group of permanent disorders of movement and posture, causing activity limitation, that are attributed to non progressive disturbances that occurred in the developing fetal or immature brain. The motor disorders of CP are often accompanied by disturbances of sensation, perception, cognition, communication, and behavior, by epilepsy, and by secondary musculoskeletal problems.
Spastic CP is described by which parts of the body are affected:
Spastic diplegia In this type of CP, spasticity is mainly in the legs, with the arms less affected or not affected at all. People with spastic diplegia might have difficulty walking because tight hip and leg muscles cause their legs to pull together, turn inward, and cross at the knees also known as scissoring.
Spastic hemiplegia Hemiplegia affects only one side of body, usually the arm is more affected than the leg.
Spastic quadriplegia Spastic quadriplegia is the most severe form of spastic CP and affects all four limbs, the trunk, and the face. People with spastic quadriplegia usually cannot walk and often have other developmental disabilities such as intellectual disability, seizures, or problems with vision, hearing or speech.
Diplegic cerebral palsy is one of the most common frequent symptoms in CP children. Those with SD usually have greater lower extremity than upper extremity involvement, the most common effects are stiff or tight muscles, lack of muscle coordination when performing voluntary movements, leg dragging, hyper myotonia of both lower extremities, talipes varus and inflexion, walking on the toes and crouched gait Neurodevelopmental treatment NDT is a problem-solving method for assessing and treating the functional limitations of individuals with CP. The NDT strategy enhances posture and function used in day-to-day context in children with CP
Is a therapeutic handling used to aid the child's movement, to redirect unwanted and ineffective movements, and to assist the child in learning patterns of movement that are more efficient and will lead to improved function. NDT should be playful and collaborative with shared control of the sessions between the client and the clinician. The NDT approach is functional, fun, efficient, effective, and collaborative with positive effects noted through the ages. While recognizing their personal improvements, clients enjoy their sessions and willingly return to improve their function and participation in life.
Motor planning:
Motor planning is defined as either an explicit i.e., decision-making or implicit process that takes into consideration both the goal and the constraints of the desired movement . This process is thought to rely on a feedforward internal model based on action simulation . Before a motor command is sent, the system briefly perceives the environmental cues to anticipate the realization of an adapted movement . Through the representation of the sensorimotor associations learned from past experiences, a prediction of the sensory consequences of the action is made. This step appears before action initiation and is believed to be based on the copy of the motor command for a subset of tasks . Motor planning is a large concept encompassing terms such as anticipatory control, motor preparation, and motor programming, with the terminology changing over time and varying by field of study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- intervention study model parallel assignment the study will include thirty children diagnosed as spastic diplegic cerebral palsy from both sexes (age 6-10 years old ) meeting the inclusion criteria, subjects divided into 2 randomized subgroups group A will receive a designed NDT program, attending three sessions per week for two consecutive months, and group B will receive a designed motor planning program, attending three sessions per week for two consecutive months.
| Arm | Type | Receives |
|---|---|---|
| group (A) | Experimental | Other: Neurodevelopmental Technique on Gait Pattern in Children With Spastic Diplegic Cerebral PalsyEach child of group A received a designed NDT program, attending three sessions per week for two consecutive months. The internationally recognized neurodevelopmental therapy (NDT) intervention will be used, consisting chiefly of three components. |
| group (B) | Experimental | Other: Motor Planning Exercises on Gait Pattern in Children With Spastic Diplegic Cerebral PalsyEach child of group B will receive a designed motor planning program, attending three sessions per week for two consecutive months. Practicing skills will help children with poor motor planning ability become more confident. There are many things we can do to help children improve their motor planning. |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Parents/legals representatives consenting to their child's participation
- Diagnosis of cerebral palsy
- Ages 3-14 years - Cooperative behavior
- Their grade of spasticity will be from 1 to 2 according to Modified Ashworth scale
- They will be on Level I and II according to Gross Motor Functional Classification System
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Neurodevelopmental Technique on Gait Pattern in Children With Spastic Diplegic Cerebral PalsyEach child of group A received a designed NDT program, attending three sessions per week for two consecutive months. The internationally recognized neurodevelopmental therapy (NDT) intervention will be used, consisting chiefly of three components: 1. Exercise training: the therapist is goal-oriented and works with the child to make a family exercise plan. The plan is developed based on specific activities of the children in the family. The plan is designed step by step, and all tasks allow the child to reach a functional goal. Having set an exercise target, the child is able to achieve the goal as his/her exercise ability increases. Subsequently, the difficulty level of the task is increased or the environment altered, so the infant continues to face challenges to exercise ability. In the process of implementing the training plan, the therapist should pay attention to the degree of completion and quality of child movements, making corrections and offering guidance twice weekly. | Other | group (A) |
| Motor Planning Exercises on Gait Pattern in Children With Spastic Diplegic Cerebral PalsyEach child of group B will receive a designed motor planning program, attending three sessions per week for two consecutive months. Practicing skills will help children with poor motor planning ability become more confident. There are many things we can do to help children improve their motor planning. Using simple language, Thinking about all the different steps to complete a sequence of steps can be difficult for children with motor planning difficulties so we should keep language simple to help them better understand what they need to do to complete a task. Breaking new skills down into smaller steps, Guiding the child through a task by providing one instruction at a time. This will help them to better follow instructions and reduce anxiety over learning a new skill. Starting with the simplest movement first, Practice the individual movements that make up a task, gradually increasing the degree of difficulty as your child gains confidence in the simpler movements. | Other | group (B) |
Primary outcome
evaluate the progress of the COP throughout the foot support phase .
Time frame: after 2 months of treatment
GAIT LINE IN DYNAMIC ANALYSIS evaluate the progress of the COP throughout the foot support phase.
change of space-time parameters of walking
Time frame: after 2 months of treatment
GAIT CYCLE IN DYNAMIC ANALYSIS change of space-time parameters of walking
change of pressure distribution
Time frame: after 2 months of treatment
Visualization of the footprint to analyze the change of pressure distribution
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
ahmed ME sharaf contact
Mohamed B ibrahim, assist .prof study chair
Kafrelsheikh University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurodevelopmental Technique on Gait Pattern in Children With Spastic Diplegic Cerebral Palsy and Motor Planning Exercises on Gait Pattern in Children With Spastic Diplegic Cerebral Palsy in people with Diplegic Cerebral Palsy, run by Kafrelsheikh University at 2 sites 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 14 inclusion and 0 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: opening soon, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ahmed ME sharaf (2001552500034, sharafahmed326@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the progress of the COP throughout the foot support phase . (time frame: after 2 months of treatment). 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 7 Feb 2025.