An interventional study of Group A and Group B in Spastic Diplegia Cerebral Palsy, sponsored by Emad Eldin Mohamed. Completed at 1 site in Egypt. Open to participants aged 9 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Emad Eldin Mohamed · Not applicable, Interventional, and Treatment
Children with spastic diplegic cerebral palsy often present with lower-limb spasticity, limited gross motor function, and reduced quality of life. Effective interventions are needed to improve functional outcomes and daily participation.
Spastic diplegia is one of the most prevalent bilateral forms of CP; it mostly affects the lower limbs and is often associated with gait disturbances, restricted movement, and impaired functional independence. Damage to the motor cortex and corticospinal pathways leads to imbalance between excitatory and inhibitory neural mechanisms, resulting in increased reflex excitability and abnormal patterns of muscle activation. Therefore, children with spastic diplegia often experience progressive restrictions in motor performance and participation as they grow.
Motor dysfunction in children with spastic diplegia develops from impaired motor control, involuntary muscle activation and muscle weakness leading to several clinical manifestations such as delayed gross motor development, persistence of basic reflexes such as the asymmetric tonic neck reflex, and increased resistance to passive movement. During the early stages of development, spontaneous movements may be limited or atypical, while locomotor development is often characterized by delayed independent walking with reduced gait efficiency. These impairments contribute significantly to limitations in functional mobility, self-care activities, and social participation.
Beyond physical impairments, children with spastic diplegia may experience reduced independence and emotional difficulties, all of which contribute to diminished health-related quality of life. Previous studies have established that improve functional ability can enhance the participation in family and community activities lead to improvement in QoL outcomes. Therefore, contemporary rehabilitation approaches emphasize the promotion of activity, participation, and psychosocial well-being. Improving QoL has become a central goal of intervention, reflecting a shift toward patient-centered care that prioritizes significant engagement and overall life satisfaction alongside functional recovery.
1,891 studies on the registry are indexed under Cerebral Palsy; 439 are open to participants now.
This study's enrollment of 60 is above the median of 34 across 1,396 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Emad Eldin Mohamed is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Aquatic Neuromotor Repatterning Program (ANRP)
Other: Group A
Targeted Neuromodulatory Shockwave Protocol (TNMSP)
Other: Group B
Underwater exercise was conducted five times per week for 12 weeks. Each session took place for 60 minutes in a therapy pool with water temperatures between 33-35°С. The water depth ranged from chest deep to waist deep, depending on the functional level and progress of each participant. Sessions were structured into five parts. Each session began with 10 minutes of warm-up consisting of water walking with support, slow water marching, and body awareness exercises using aquatic foam noodles. After the warm-up, patients spent 15 minutes practicing neuromotor control in buoyancy. The goals of this portion were to reduce co-contraction of muscles and increase ability to have selective motor control.
Group B received a Targeted Neuromodulatory Shockwave Protocol (TNMSP). The protocol involves the combined application of extracorporeal shockwave therapy (ESWT) and the targeted immediate functional activation. The rationale behind the treatment is the concept that spasticity reduction achieved through the use of ESWT would facilitate enhanced motor learning and promote the emergence of normal motor patterns. The intervention was lasted for 12 weeks and involved 1 ESWT and 2 functional activation sessions weekly. The ESWT component of the protocol was selected to maximize the neuromodulatory potential by promoting plasticity within the central nervous system and to consolidate the motor patterns introduced during the functional activation
1- Modified Ashworth Scale (MAS)
The MAS measures the muscle group's resistance to passive stretching on a six-point ordinal scale that ranges from 0 (no increase in muscle tone) to 4. A score of 1 indicates a slight increase in muscle tone with a catch and release, whereas a score of 2 indicates a more notable increase in muscle tone across the range of motion. A score of 3 shows a significant increase in muscle tone; passive movement is complex, and there is a "catch" at a particular place in the range of motion. A score of 4 represents stiff flexion or extension.
Time frame: 12 weeks
2- The Gross Motor Function Measure-66 (GMFM-66)
The Gross Motor Function Measure (GMFM) is a standardized tool for evaluating gross motor functions in children and adolescents with motor impairments, particularly CP. It is frequently used in rehabilitative settings to monitor development. The GMFM-66 is a subset of the GMFM-88's original 88 items organized into five dimensions: lying and rolling (4 items), sitting (15 items), crawling and kneeling (10 items), standing (13 items), and walking, running, and jumping (24 items).
Time frame: 12 weeks
3- Pediatric Quality of Life Inventory (PedsQL)
PedsQL TM is developed to measure children's health-related quality of life in the form of physical, psychological, and social functioning of the child and allows for the measurement of both overall (generic) and disease-specific quality of life. The four scales that comprise this generic battery are Physical Functioning (8 items), Emotional Functioning (5 items), Social Functioning (5 items), and School Functioning (5 items). Evidence of discriminatory and construct validity supports its use as a reliable and valid measure of health-related quality of life among children's populations.
Time frame: 12 weeks
Ran from Feb 2024 to primary completion in Aug 2025, 18 months.
Of 882 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's 18 months is above that.
Counting every sponsor, half of 900 studies reached it within 12 months; a quarter within 5 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Emad Eldin Mohamed