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

November 18, 2024 updated by: Riphah International University

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 1234
        • RehabCure

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
Experimental: Group B (Core Stability Exercises)
Participants will receive core stability exercises, i.e., abdominal draw-in, roll-up, superman, and bridging.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Finger to nose test
Time Frame: 12th week
The Finger-to-Nose Test measures smooth, coordinated upper-extremity movement by having the examinee touch the tip of his or her nose with his or her index finger. Evaluation of coordination with the Finger-Nose Test is an essential part of the neurological examination
12th week
Heel shin test
Time Frame: 12th week
The heel-shin test is a part of the neurological examination of coordination: the patient runs the sole of one foot up and down the shin of the opposite leg.
12th week
Catching and throwing tasks
Time Frame: 12th week
Ball catching is a skill included in most tests for assessing the motor impairment of children with a mild motor deficit. To objectively measure ball catching short and long ball catching tests were developed to assess children between seven and nine years of age
12th week
PBS (Pediatric Ballance Scale)
Time Frame: 12th week
A modified version of the Berg Balance Scale, the Pediatric Balance Scale is used to evaluate school-age children's functional balance abilities. The 14 items on the scale have a maximum score of 56 points and are rated from 0 (lowest function) to 4 (highest function).
12th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: aruba saeed, phd, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

July 30, 2025

Study Registration Dates

First Submitted

November 18, 2024

First Submitted That Met QC Criteria

November 18, 2024

First Posted (Estimated)

November 20, 2024

Study Record Updates

Last Update Posted (Estimated)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 18, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR&AHS/24/0240

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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