Clinical trial NCT06696989: Comparative Effects of Frenkel's and Core Stability Exercises in Children With Cerebral Palsy
Official title: Comparative Effects of Frenkel's and Core Stability Exercises on Coordination and Balance in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cerebral Palsy (CP)
Keywords: Cerebral Palsy
Core Stability
Balance
Frenkel exercises
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Finger to nose test
timeFrame: 12th week
measure: Heel shin test
timeFrame: 12th week
measure: Catching and throwing tasks
timeFrame: 12th week
measure: PBS (Pediatric Ballance Scale)
timeFrame: 12th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: RehabCure
state: Punjab
Study officials:
affiliation: Riphah International University
name: Aruba Saeed, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.