Comparative Effects of Frenkel's and Core Stability Exercises in Children With Cerebral Palsy

NCT ID: NCT06696989

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-24
• Study Completion Date: 2025-07-30

Brief Summary

The aim of this study is to determine and compare the effects of Frenkel's and core stability exercises on the motor function, postural stability and core muscle strength in children with cerebral palsy.

Detailed Description

Cerebral palsy (CP) is a brain injury that manifests as a mobility and posture impairment in infancy or early childhood. Frenkel exercises are series of movements with increasing difficulty that can be performed by ataxic patients in order to regain coordinated, smooth and rhythmic movement. The Core stability Exercises are for the spine, pelvis, and kinetic chain to all balance properly under stress, core stability is necessary. The aim of this study is to determine and compare the effects of Frenkel's and core stability exercises on the motor function, postural stability and core muscle strength in children with cerebral palsy. This will be a Randomized Clinical Trial in which 50 participants with cerebral palsy will be included as per sample size calculation through non probability convenience sampling technique. The study will be single blinded. Participants that achieve the required standards of inclusion and exclusion criteria will be randomly allocated using online randomization tool into two Groups. Group A will receive Frenkel's exercises and Group B will receive core stability exercises, both groups will receive the treatment for 40 minutes with the routine physical therapy for 20 minutes and short-term rest intervals in between for 3 alternative days per week for 12 weeks. Participants initial screening will be done through Gross Motor Function Classification System (GMFCS). The balance will be assessed through the Pediatric Balance Test (PBS), coordination will be assessed through Finger and Nose Test, Heel Shin Test, Catching and Throwing Tasks.

Conditions

Cerebral Palsy (CP)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A ( Frenkel's exercises)

In this group, participants will receive Frenkel's exercises for the lower limb in lying, sitting, and standing positions. And for the upper limb.

Group Type: EXPERIMENTAL

Frenkel's exercises

Intervention Type: OTHER

In this group, participants will receive Frenkel's exercises, and the total treatment session will be 60 minutes of routine physical therapy, i.e., breathing, stretching, ROM's, and joint mobility, with rest intervals in between for 20 minutes. To begin the intervention, the investigator will perform Frenkel's exercises for 40 minutes in total, with rest intervals between each exercise, initially performing 5 repetitions and then gradually progressing to 10 and then 15 repetitions, respectively, after 2 weeks.

Group B (Core Stability Exercises)

Participants will receive core stability exercises, i.e., abdominal draw-in, roll-up, superman, and bridging.

Group Type: EXPERIMENTAL

Core stability exercises

Intervention Type: OTHER

This group participants will receive core stability exercises, and the total treatment session will also be 60 minutes. The routine physical therapy includes breathing, stretching, joint rotations, ROM's, and frequent periods of rest in between the treatment sessions. To begin the intervention the investigator will perform core stability exercises for 40 minutes in total with rest intervals between each exercise and initially performing 5 repetitions and then gradually progressing to 10 and then 15 repetitions, respectively after 2 weeks.

Interventions

Frenkel's exercises

In this group, participants will receive Frenkel's exercises, and the total treatment session will be 60 minutes of routine physical therapy, i.e., breathing, stretching, ROM's, and joint mobility, with rest intervals in between for 20 minutes. To begin the intervention, the investigator will perform Frenkel's exercises for 40 minutes in total, with rest intervals between each exercise, initially performing 5 repetitions and then gradually progressing to 10 and then 15 repetitions, respectively, after 2 weeks.

Intervention Type: OTHER

Core stability exercises

This group participants will receive core stability exercises, and the total treatment session will also be 60 minutes. The routine physical therapy includes breathing, stretching, joint rotations, ROM's, and frequent periods of rest in between the treatment sessions. To begin the intervention the investigator will perform core stability exercises for 40 minutes in total with rest intervals between each exercise and initially performing 5 repetitions and then gradually progressing to 10 and then 15 repetitions, respectively after 2 weeks.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• The participants fulfilling the given criteria will be included.
• Age: 6 To 12 Years
• Gender: Both male and female
• Children with ataxic cerebral palsy
• Children having level II and III on Gross Motor Functional Classification System (GMFCS)
• Children able to understand the test instruction, able to sit and stand.
• Children with and without using Botulinum Toxin Injections
• The Pediatric Balance Scale (PBS) of 54.6

Exclusion Criteria

• Severe Cognitive Dysfunction
• Visual problems
• Vestibular Dysfunction
• Uncontrolled epilepsy
• Severe Orthopedic Condition affecting Lower limbs Mobility

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aruba Saeed, Phd

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

RehabCure

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

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Other Identifiers

REC/RCR&AHS/24/0240

Identifier Type: -

Identifier Source: org_study_id