Spastic Diplegia Cerebral Palsyspastic CPNCT07878949
Comparative Effects of Under Water Exercise and Radial Extracorporeal Shockwave Therapy on Lower-Limb Spasticity, Gross Motor Function, and Quality of Life in Children With Spastic Diplegic Cerebral Palsy: A Randomized Controlled Trial
A study testing Group A and Group B in people with Spastic Diplegia Cerebral Palsy, run by Emad Eldin Mohamed at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Spastic Diplegia Cerebral Palsy
- What is being tested?
- Group A and Group B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2024to 8 Sep 2025
- 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 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children had a MAS score of 1 to 4 in the affected lower limbs, were classified as GMFCS levels I to III, had the ability to follow verbal instructions and participate in the treatment, had no acute illness at the time of recruitment, with no changes in medications affecting muscle tone during the study period program were eligible for the study. Inclusion criteria for mothers were as follows: (1) housewives or those who gave up work due to their child's condition, (2) 20 years or older, and (3) primary caregivers.
Who cannot join
- Children with non-spastic CP, orthopedic surgery for the lower extremities within the previous 12 months, botulinum toxin injections within the previous 6 months, fixed contractures or severe deformities, uncontrolled epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Spastic Diplegia Cerebral Palsy
- Being tested
- Group A, Group B
- Keywords
- cerebral palsy, Spastic Diplegia Cerebral Palsy, underwater exercise, radial extracorporeal shock wave therapy
- Medical subject headings
- Cerebral palsy, spastic, diplegic, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group AOther
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 BOther
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
| Study group | Role | What they receive |
|---|---|---|
| group A: underwater exercise | Experimental | Aquatic Neuromotor Repatterning Program (ANRP) Receives: Other: Group A |
| group B: radial extracorporeal shock wave therapy. | Experimental | Targeted Neuromodulatory Shockwave Protocol (TNMSP) Receives: Other: Group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (2)
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).
Measured: 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.
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 posted16 Oct 2026
- Study start10 Feb 2024
- Primary completion22 Aug 2025
- Study completion8 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Diplegia Cerebral PalsyStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emad Eldin Mohamed
- Sponsor type
- University, hospital or other
- Collaborators
- Middle East University
- Responsible party
- Sponsor-investigator, Emad Eldin Mohamed, Middle East University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878949
- Sponsor's protocol ID
- 987897
- Acronym
- spastic CP
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Under Water Exercise and Radial Extracorporeal Shockwave Therapy on Lower-Limb Spasticity, Gross Motor Function, and Quality of Life in Children With Spastic Diplegic Cerebral Palsy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07878949
- Acronym / sponsor ID
- spastic CP / 987897
- Conditions
- Spastic Diplegia Cerebral Palsy
- Keywords
- cerebral palsy, Spastic Diplegia Cerebral Palsy, underwater exercise, radial extracorporeal shock wave therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Emad Eldin MohamedUniversity, hospital or other
- Collaborators
- Middle East University
- Study start
- 10 Feb 2024 (actual)
- Primary completion
- 22 Aug 2025 (actual)
- Study completion
- 8 Sep 2025 (actual)
- First posted
- 16 Oct 2026 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A: underwater exercise | Experimental | Other: Group AAquatic Neuromotor Repatterning Program (ANRP) |
| group B: radial extracorporeal shock wave therapy. | Experimental | Other: Group BTargeted Neuromodulatory Shockwave Protocol (TNMSP) |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children had a MAS score of 1 to 4 in the affected lower limbs, were classified as GMFCS levels I to III, had the ability to follow verbal instructions and participate in the treatment, had no acute illness at the time of recruitment, with no changes in medications affecting muscle tone during the study period program were eligible for the study. Inclusion criteria for mothers were as follows: (1) housewives or those who gave up work due to their child's condition, (2) 20 years or older, and (3) primary caregivers.
Key exclusion criteria (1 listed)
- Children with non-spastic CP, orthopedic surgery for the lower extremities within the previous 12 months, botulinum toxin injections within the previous 6 months, fixed contractures or severe deformities, uncontrolled epilepsy
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 |
|---|---|---|
| Group AUnderwater 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. | Other | group A: underwater exercise |
| Group BGroup 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 | Other | group B: radial extracorporeal shock wave therapy. |
Primary outcome
1- Modified Ashworth Scale (MAS)
Time frame: 12 weeks
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.
2 secondary outcomes
2- The Gross Motor Function Measure-66 (GMFM-66)
Time frame: 12 weeks
3- Pediatric Quality of Life Inventory (PedsQL)
Time frame: 12 weeks
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 16 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A and Group B in people with Spastic Diplegia Cerebral Palsy, run by Emad Eldin Mohamed at 1 site 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 1 inclusion and 1 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 16 Oct 2026. 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 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?
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?
1- Modified Ashworth Scale (MAS) (time frame: 12 weeks). 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 16 Oct 2026.