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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05614167
Other study ID # Omnya3
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 7, 2022
Est. completion date February 12, 2023

Study information

Verified date April 2023
Source Badr University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Muscle strength can be defined as the ability of skeletal muscle to develop force for the purpose of providing stability and mobility within the musculoskeletal system, so that functional movement can take place.


Description:

Cerebral palsy describes a group of disorders of the development of movement and posture, causing activity limitation, that are attributed to non-progressive disturbances that occurred in the developing fatal or infant brain. The motor disorders of cerebral palsy are often accompanied by disturbances of sensation, cognition, communication, perception, and/or behaviour, and/or by a seizure disorder The development and changes in motor function, both natural and with therapy, can be assessed using the Gross Motor Function Measure (GMFM) created for children with CP


Recruitment information / eligibility

Status Completed
Enrollment 97
Est. completion date February 12, 2023
Est. primary completion date January 12, 2023
Accepts healthy volunteers No
Gender All
Age group 6 Years to 12 Years
Eligibility Inclusion Criteria: 1. Their age between 6 and 12 years old. 2. Grade 1and 2 according to the Modified Ashworth scale (RW and Smith, 1987). 3. They could walk with limitation or holding on according to GMFCS (level I, II) (Palisano et al., 1997). 4. They were able to understand and follow verbal instructions. Exclusion Criteria: 1. Children with any visual or auditory problems. 2. Children with any surgical interference in the lower limb. 3. Children with any structural deformities in joints and bones of lower limbs. 4. Children with any special medications affecting muscle functions (anti-spastic drugs). 5. Children who suffer from other diseases or associated disorders that interfered with physical activity.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
correlation
A total of 97 children with CP between the ages of six and 12 years participated in the study. Muscle strength was measured with a handheld dynamometer. Motor function in children with CP was classified with the Gross Motor Function Classification System (GMFCS), graded with the Gross Motor Function Measure (GMFM)

Locations

Country Name City State
Egypt Badr University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Badr University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gross motor function measure standing and walking domain 3 months
Primary Isometric muscle strength a handheld dynamometer 3 months
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