Clinical trial NCT06813599: The Best Intervention to Improve Gait Pattern in Children with Spastic Diplegic Cerebral Palsy
Official title: Effect of Motor Planning Exercises Versus Neurodevelopmental Technique on Gait Pattern in Children with Spastic Diplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diplegic Cerebral Palsy
Keywords: CP
Diaplegic
motor planning
Gait pattern
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Parents/legals representatives consenting to their child's participation
2. Diagnosis of cerebral palsy
3. Ages 3-14 years - Cooperative behavior
4. Their grade of spasticity will be from 1 to 2 according to Modified Ashworth scale
5. They will be on Level I and II according to Gross Motor Functional Classification System
6. The child will be able to follow verbal commands and instructions.

Exclusion Criteria: The children will be excluded if they have one of the following:

1. Previous neurological or orthopedic surgery in the lower extremities.
2. Botox injection in the lower extremities in the past 6 months.
3. Fixed deformity in the joints of lower limb.
4. Severe hearing and visual problems.
5. Different diagnosis than cerebral palsy.
6. Inability to "walk freely or with a mobility aid (GMFCS Level IV or V)" .
7. Irregular attendance at assessments or therapy sessions.

Primary outcomes:
measure: evaluate the progress of the COP throughout the foot support phase .
timeFrame: after 2 months of treatment
measure: change of space-time parameters of walking
timeFrame: after 2 months of treatment
measure: change of pressure distribution
timeFrame: after 2 months of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafr Ash Shaykh university
city: Kafr Ash Shaykh
country: Egypt
facility: Kafr Ash Shaykh University
Study officials:
affiliation: kafr elsheikh university
name: Mohamed B ibrahim, assist .prof
role: STUDY_CHAIR
References: