NCT06473181

Brief Summary

The term of "core stability" explains the capacity to control the position and movement of the central portion of the body. Core stability training targets the muscles deep within the abdomen that attach to the spine, pelvis and shoulders, that help in the preservation of proper posture and provide the basis for movements of extremities in a coordinated manner. The aim of core stability training is to achieve the optimal physical ability tom the normal state of the spine in daily activities, in addition to developing the endurance and coordination of these core stability muscles.The Core stability may help to improve dynamic balance and muscle coordination between lower and upper extremities, as well as reducing injury risk and muscle imbalances . Core stability exercises have a positive effect on reducing pain, activating deep abdominal muscles, elevating the stability of lumbar spine and improving physical function in patients . The stability of the lumbo-pelvic region is crucial to provide a foundation for movement of the upper and lower extremities, to support loads, and to protect the spinal cord and nerve roots . The core muscles stabilize the spine and trunk during movements such as jumping, running, and throwing .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

May 24, 2024

Last Update Submit

June 21, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Pediatric balance scale

    To assess the static balance Pediatric Balance Scale scores are divided into 14 items, scored between 0 to 4. What counts as 0 and 4 will vary from exercise to exercise, but 0 is considered the worst performance, and 4 is the best. Retrials are unnecessary if they score a 4 on the first trial. Since each exercise has three trials, the score rating you must tick for each item should be the best of the three trials. Some exercises have time and distance requirements. Points will be deducted if they cannot complete the time and distance requirements and require external support or assistance from another person. After all the exercises have been performed, you simply need to add up all the score ratings per item to calculate the total test score. The maximum score is 56.

    Baseline

  • Gross motor function classification system

    To assess the gross motor function and standing The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline. However, most of the items have specific descriptors for each score. It is imperative that the guidelines contained in the manual be used for scoring each item. SCORING KEY 0 = does not initiate 1. = initiates 2. = partially completes 3. = completes

    Baseline

  • Modified Ashworth scale

    To measure the degree of spasticity to enroll children in the study scoring 0 No increase in tone 1 slight increase in tone giving a catch when slight increase in muscle tone, manifested by the limb was moved in flexion or extension. 1+ slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout (ROM ) 2 more marked increase in tone but more marked increased in muscle tone through most limb easily flexed 3 considerable increase in tone, passive movement difficult 4 limb rigid in flexion or extension

    Baseline

  • Weight-Height scale

    To measure weight and height to calculate BMI for each patient . The child was wearing a thin layer of clothes to calculate BMI according to the following equation: BMI (Kg/m²)= weight(kg) ÷ height²(m2)

    Baseline

Study Arms (1)

Core stability exercises that is part of physiotherapy rehabilitation

OTHER

Physical therapy including core stability exercises and improving developmental milestones to improve children development

Other: Core stability exercises

Interventions

Exercises applied to trunk , pelvis and abdomen to improve ability to stand , walk and balance.

Core stability exercises that is part of physiotherapy rehabilitation

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • A clinical diagnosis of diplegic CP made by paediatricians or pediatric neurologists
  • children spasticity grades must range from 1 to 1+ according to MAS
  • age must range from 4 to 10 years
  • They Must be in level I or II on the Gross Motor Function Classifcation System (GMFCS)

You may not qualify if:

  • A permanent deformity (bony or soft tissue contractures)
  • visual or auditory defects
  • Botox application to the lower extremity in the past 6 months or undergone a previous surgical intervention to ankle and knee
  • history of epileptic seizure and any diagnosed cardiac or orthopaedic disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Core stability training In Diplegic Cerebral Palsy, Master

    Kafr Elsheikh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Physiotherapist Nancy Mohamed Eid Metwaly shaban, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

May 24, 2024

First Posted

June 25, 2024

Study Start

July 1, 2024

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

June 25, 2024

Record last verified: 2024-06