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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06407882
Other study ID # REC/RCR&AHS/23/Moneeza Ahmad
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 15, 2024
Est. completion date August 15, 2024

Study information

Verified date May 2024
Source Riphah International University
Contact Imran Amjad, PhD
Phone 9233224390125
Email Imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Cerebral palsy (CP) is defined as a neurodevelopmental disorder in which there are abnormalities of motor skills, muscle tone ,and, movement and is caused by injury to the developing brain. Risk factors for cerebral palsy are most probably intrauterine exposure to infection or inflammation and disorders of coagulation.Cerebral palsy (CP) is classified as Spastic, Athetoid, Tremor, Rigidity, Ataxic, Atonic, and Mixed. Cerebral Palsy (CP) is the most common cause of physical disability in early childhood and overall, the CP rate is between 2 and 3 per 1000 live births.There are several interventions to manage cerebral palsy depending upon the severity and type of cerebral palsy and hence requires a multidisciplinary setting for proper improvement and management.One of the important intervention is conductive education including conductive exercises (CE). Conductive education (CE) is a useful educational system for the management of motor disabled individuals whose disability and dysfunction was due to the damage to the central nervous system, mainly at the pre-, peri- or post-natal period of life. Conductive exercises basically include task-oriented learning within highly structured programs and conductors who are trained in special education and therapy administer the conductive education program.


Description:

Group A: Experimental group: Group A will perform Conductive exercises (CE) in addition to routine physical therapy. Conductive exercises program will include Squat-position, Rising from squat to stand, Sitting on the stool, Prone lying, High kneeling and half kneeling, Sitting, lying and high kneeling, Walking in parallel bars, Sitting to standing, Floor to standing, Picking up toys from the floor, Balance on one foot on different surfaces and heights, Crawling over foams of different sizes and shapes, Climbing steps or stairs sometimes while carrying a toy. These exercises will improve motor skills and activities of daily living by improving the muscle strength. Group B: Control group: Group B will perform routine physical therapy (RPT) alone. Active and passive movements, Passive stretching, strengthening exercises, weight bearing exercises. Both the groups will receive intervention for 45 minutes per session 5 days in a week for 2 month. Data will be collected at baseline and after the completion of the study. Data will be collected after ethical approval and consent. All the personal information of the patient will be kept confidential.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 56
Est. completion date August 15, 2024
Est. primary completion date July 15, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Years to 12 Years
Eligibility Inclusion Criteria: - Spastic cerebral palsy - GMFCS level I, II and III - Age group 6 to 12 years - Either gender Exclusion Criteria: - Had a botulinum injection for reduce spasticity - Subjects with any cardiac problem(congenitally) - Children who are having visual and hearing deficits

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Conductive Exercises
Conductive education (CE) is a useful educational system for the management of motor disabled individuals whose disability and dysfunction was due to the damage to the central nervous system, mainly at the pre-, peri- or post-natal period of life. Conductive exercises basically include task-oriented learning within highly structured programs and conductors who are trained in special education and therapy administer the conductive education program

Locations

Country Name City State
Pakistan Riphah International University Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

Gulati S, Sondhi V. Cerebral Palsy: An Overview. Indian J Pediatr. 2018 Nov;85(11):1006-1016. doi: 10.1007/s12098-017-2475-1. Epub 2017 Nov 20. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Gross motor function measure-88 (GMFM-88) The Gross Motor Function Measure-88 (GMFM88) is a tool which is used to measure changes in gross motor function in cerebral palsy children and has been commonly used by researchers .The GMFM-88 consists of 88 items in five dimensions which are lying and rolling (GMFM-A); sitting (GMFM-B); crawling and kneeling (GMFM-C); standing (GMFM-D); and walking, running and jumping (GMFM-E).The psychometric properties of the adapted GMFM-88 for children with CP are reliable. 8 weeks
Primary Cerebral Palsy Quality of Life Questionnaire (CP QOL) The Cerebral Palsy Quality of Life for Children (CP QOL-Child) was made to assess several aspects of subjective happiness and well-being, rather than ill-being or functioning. It is productive to establish a profile of qualify of life of cerebral palsy children to understand their subjective perception of their life.The reliability and validity of the CP QOL-Child have been established, including internal consistency, test-retest reliability, and construct validity 8 weeks
Primary ABILHAND questionnaire This questionnaire is used to evaluate the effects of interventions that are useful for improving functional limitations under the different contextual situations.This is a valid and reliable assessment method which is used to assess a child's both unimanual and bimanual upper limb activities.This questionnaire focuses on the child's manual performance of 21 daily activities as perceived by the parents 8 weeks
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