NCT06407882

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 6, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

May 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

August 2, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

May 6, 2024

Last Update Submit

July 31, 2024

Conditions

Keywords

ADLS,Cerebral palsy,Motor skills,Quality of life

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Behavioral: Conductive Exercises

Routine Physical Therapy

ACTIVE COMPARATOR

Group B will perform routine physical therapy (RPT) alone. Active and passive movements, Passive stretching, strengthening exercises, weight bearing exercises.

Behavioral: Routine Physical Therapy

Interventions

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

Experimental Group

Group B will perform routine physical therapy (RPT) alone. Active and passive movements, Passive stretching, strengthening exercises, weight bearing exercises.

Routine Physical Therapy

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Spastic cerebral palsy
  • GMFCS level I, II and III
  • Age group 6 to 12 years
  • Either gender

You may not qualify if:

  • Had a botulinum injection for reduce spasticity
  • Subjects with any cardiac problem(congenitally)
  • Children who are having visual and hearing deficits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

Related 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.

    PMID: 29152685BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Moneeza Ahmad, MS*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: It will be Randomized control trial in which non probabilty convenient sampling will be used. Two groups of 6-12 age will be formed in which participants will be randomly divided. Group A will only receive Conductive education and group B will receive conventional physical therapy.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2024

First Posted

May 9, 2024

Study Start

May 15, 2024

Primary Completion

July 15, 2024

Study Completion

July 30, 2024

Last Updated

August 2, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations