Clinical trial NCT06930053: Effect of Action Observation Training Versus Core Stability Training on Hand Functions in Children With Hemiplegic Cerebral Palsy
Official title: Effect of Action Observation Training Versus Core Stability Training on Hand Functions in Children With Hemiplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hand Functions on Hemiplegic Cerebral Palsy
Keywords: Action observation training (AOT)
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 52
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment protocol in Group A, Core stability training:

The study group will receive core stability exercises, which consist of three levels. Each level took 4 weeks. The difficulty of each level varies in proprioception, balance, and stability as it started from exercising on a stable surface "mat" and ended with unstable surface "physioball" .

Treatment protocol in Group B, Action observation therapy protocol:

The examined group got 30 minutes of a standard,selected physical therapy program in addition to 30 minutes of AOT on the upper limb (total session time: 1 hour), 3 sessions per week for three consecutive months (total therapy time: 3 hours/week). Action observation was executed with therapist guidance and repeated practice (3 repetitions for each task).

Treatment protocol in Group c, combination of Action observation therapy and core stability training
Primary purpose: TREATMENT

Brief summary: This study will be conducted to compare between the effectiveness of Action observation therapy (AOT) and core stability training and the combination of Action observation therapy (AOT) and core stability training on hand function in hemiplegic CP

Detailed description: Cerebral palsy (CP) refers to a collection of permanent mobility and postural impairments that are caused by non-progressive disruptions in the fetal or infant brain throughout development. Children with CP have motor abnormalities that are commonly accompanied by sensory and cognition disorders as well as seizures and secondary musculoskeletal difficulties. Cerebral palsy can be broken down into four basic categories based on the degree of activity restriction: motor abnormalities, accompanying impairments, anatomical and neuroimaging results, and etiology and timing of motor problems . It is a chronic and disabling childhood condition that occurs in 1.5/1,000 to 3/1,000 live births .Pregnancy age under 20 years, birth weight under 2500 gramme , risk factors related to the mother, pregnancy variables (placental dislodgement ,twining), and fetal factors are all examples of CP causes or risk factors(bradycardia, fetal malformation, poor fetal growth) As a well-known neurodevelopmental disorder, CP can begin in early childhood and last throughout life. For example, non-progressive abnormalities in the growing fetus or infant brain might cause activity limitations, poor sensation and cognition as well as mobility and posture issues .

Three out of every 1000 children with CP have a movement and coordination disorders which are compromised in people with CP due to both decreased brain control and secondary alterations in muscle characteristics. It is difficult to quantify the degree and functional significance of changes in muscle characteristics for individual patients with CP, which makes therapy planning difficult .

Early intervention for the upper limb in hemiplegia remains challenging, though progress is being made. It was concluded that the difficulties of outcome assessment in the youngest infants and children, which make evaluation of interventions very difficult. The diversity of the population under study, in terms of lesion type, differences in post-lesional reorganization, and the degree to which other factors such as vision, sensation, and cognitive ability impact on hand function, must also be considered .

Eligibility criteria: Inclusion Criteria:

1. Their age will be ranged from four to eight years.
2. Their grade of spasticity will be from 1 to 1+ according to Modified Ashworth scale .
3. They will be on Level I and II according to Gross Motor Functional Classification System (GMFCS) .
4. 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. history of orthopedic surgery in the affected upper limb
2. Botox injection in the upper limb in the past 6 months or planned to have one during study time

4-Fixed deformities or contructures in spine. 5- A history of epileptic seizure and cardiac or respiratory problems. 6- Severe hearing and visual defect.

Primary outcomes:
measure: evaluates the quality of upper extremity skill function through 33 activity items of 4 domains: dissociated movement consists of 19 items, grasp consists of 6 items, weight-bearing consists of 5 items, and protective extension consists of 3 items
timeFrame: After 12 week
measure: Assessment of the grip strength
timeFrame: After 12 week
measure: Measure hand function for activities of daily living. It has 7 items include: writing, turning over 3-by-5 inch cards, picking up small common objects, simulated feeding, stacking checkers, picking up large light objects and picking up large heavy object
timeFrame: After 12 week
Secondary outcomes:
Other outcomes:
Locations:
city: El beheria
country: Egypt
facility: Ahmed Abdou Ragab Abdou
Study officials:
affiliation: kafr-elsheikh university
name: Mohamed Bedair Ibrahim, Professor of Physical Therapy
role: PRINCIPAL_INVESTIGATOR
References: