The Best Intervention to Improve Gait Pattern in Children with Spastic Diplegic Cerebral Palsy

NCT06813599 | Not Yet Recruiting DMC

• 1 other identifier: KFS1RB200-391
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Diplegic Cerebral Palsy

Keywords

CP; Diaplegic; motor planning; Gait pattern

Outcome Measures

Primary Outcomes (3)

• 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.

  after 2 months of treatment

• change of space-time parameters of walking

  GAIT CYCLE IN DYNAMIC ANALYSIS change of space-time parameters of walking

  after 2 months of treatment

• change of pressure distribution

  Visualization of the footprint to analyze the change of pressure distribution

  after 2 months of treatment

Study Arms (2)

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.

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.

Other: Motor Planning Exercises on Gait Pattern in Children With Spastic Diplegic Cerebral Palsy

Interventions

Neurodevelopmental Technique on Gait Pattern in Children With Spastic Diplegic Cerebral Palsy OTHER

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: 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.

group (A)

Motor Planning Exercises on Gait Pattern in Children With Spastic Diplegic Cerebral Palsy OTHER

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.

group (B)

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (2)

Kafr Ash Shaykh university

Kafr ash Shaykh, Egypt

Location

Kafr Ash Shaykh University

Kafr ash Shaykh, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Mohamed B ibrahim, assist .prof

  kafr elsheikh university

  STUDY CHAIR

Central Study Contacts

ahmed ME sharaf

CONTACT

2001552500034; sharafahmed326@gmail.com

ahmed ME sharaf

CONTACT

sharafahmed326@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator at faculty of physical therapy Rashid University

Model Details: 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.

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 7, 2025
• Study Start: March 1, 2025
• Primary Completion: May 28, 2025
• Study Completion: July 1, 2025
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

EG (2)