NCT06696989

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2024

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

November 20, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

November 18, 2024

Last Update Submit

November 18, 2024

Conditions

Keywords

Cerebral PalsyCore StabilityBalanceFrenkel exercises

Outcome Measures

Primary Outcomes (4)

  • Finger to nose test

    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

    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

    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)

    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

Study Arms (2)

Group A ( Frenkel's exercises)

EXPERIMENTAL

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

Group B (Core Stability Exercises)

EXPERIMENTAL

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

Other: Core stability exercises

Interventions

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 A ( Frenkel's 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.

Group B (Core Stability Exercises)

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RehabCure

Lahore, Punjab Province, 1234, Pakistan

Location

Related Publications (9)

  • Kang H. Sample size determination and power analysis using the G*Power software. J Educ Eval Health Prof. 2021;18:17. doi: 10.3352/jeehp.2021.18.17. Epub 2021 Jul 30.

    PMID: 34325496BACKGROUND
  • Hlaing SS, Puntumetakul R, Khine EE, Boucaut R. Effects of core stabilization exercise and strengthening exercise on proprioception, balance, muscle thickness and pain related outcomes in patients with subacute nonspecific low back pain: a randomized controlled trial. BMC Musculoskelet Disord. 2021 Nov 30;22(1):998. doi: 10.1186/s12891-021-04858-6.

    PMID: 34847915BACKGROUND
  • Abd-Elfattah HM, Aly SM. Effect of Core Stability Exercises on Hand Functions in Children With Hemiplegic Cerebral Palsy. Ann Rehabil Med. 2021 Feb;45(1):71-78. doi: 10.5535/arm.20124. Epub 2021 Feb 9.

    PMID: 33557483BACKGROUND
  • Ali MS, Awad AS, Elassal MI. The effect of two therapeutic interventions on balance in children with spastic cerebral palsy: A comparative study. J Taibah Univ Med Sci. 2019 Jul 26;14(4):350-356. doi: 10.1016/j.jtumed.2019.05.005. eCollection 2019 Aug.

    PMID: 31488967BACKGROUND
  • Manko G, Pieniazek M, Tim S, Jekielek M. The Effect of Frankel's Stabilization Exercises and Stabilometric Platform in the Balance in Elderly Patients: A Randomized Clinical Trial. Medicina (Kaunas). 2019 Sep 11;55(9):583. doi: 10.3390/medicina55090583.

    PMID: 31514453BACKGROUND
  • Horber V, Fares A, Platt MJ, Arnaud C, Krageloh-Mann I, Sellier E. Severity of Cerebral Palsy-The Impact of Associated Impairments. Neuropediatrics. 2020 Apr;51(2):120-128. doi: 10.1055/s-0040-1701669. Epub 2020 Mar 2.

    PMID: 32120428BACKGROUND
  • Graham D, Paget SP, Wimalasundera N. Current thinking in the health care management of children with cerebral palsy. Med J Aust. 2019 Feb;210(3):129-135. doi: 10.5694/mja2.12106. Epub 2019 Feb 10.

    PMID: 30739332BACKGROUND
  • Paul S, Nahar A, Bhagawati M, Kunwar AJ. A Review on Recent Advances of Cerebral Palsy. Oxid Med Cell Longev. 2022 Jul 30;2022:2622310. doi: 10.1155/2022/2622310. eCollection 2022.

    PMID: 35941906BACKGROUND
  • Khan SA, Talat S, Malik MI. Risk factors, types, and neuroimaging findings in Children with Cerebral Palsy. Pak J Med Sci. 2022 Sep-Oct;38(7):1738-1742. doi: 10.12669/pjms.38.7.6175.

    PMID: 36246690BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Aruba Saeed, Phd

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2024

First Posted

November 20, 2024

Study Start

October 24, 2024

Primary Completion

June 30, 2025

Study Completion

July 30, 2025

Last Updated

November 20, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations