Clinical trial NCT06673797: Effects of Swiss Ball vs Frenkle Exercises on Static and Dynamic Balance in Ataxic CP
Official title: Effects of Swiss Ball vs Frenkle Exercises on Static and Dynamic Balance in Ataxic Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Ataxic
Balance
Pediatric balance scale
Swiss ball
Frenkel
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 18
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It will be randomized controlled trial in which non probability convenient sampling will be used two groups of ages 5-8 age will be formed in which participants will be randomly divided group A will be receive effects of swiss ball exercises and group B will receive Frenkel exercises on both dynamic and static balance.
Primary purpose: TREATMENT

Brief summary: Several studies have highlighted the significant impact of cerebral palsy, a prevailing neurological and musculoskeletal developmental disorder among childhood disabilities worldwide. Within the spectrum of cerebral palsy, ataxic CP stands as the least prevalent type, accounting for 5 to 10% of all cases. Individuals diagnosed with ataxic CP encounter difficulties in fine motor skills, precision, and coordination, and exhibit an unsteady gait, some of which are linked to compromised postural control and inadequate core stability. These issues culminate in functional limitations, heightening the risk of falls, and further contributing to the overall disability experienced by the patients. Consequently, there exists a need to prioritize research and develop targeted treatment protocols specifically for ataxic CP. It is crucial to emphasize the enhancement of postural control and coordination, with particular emphasis on improving static and dynamic balance during rehabilitation. Implementing Swiss ball exercises and Frenkel exercises in the rehabilitation protocol for children with ataxic cerebral palsy can significantly diversify treatment strategies. These exercises play a pivotal role in supporting these children to either sustain or regain their ability to function independently, reduce the risk of falls, and notably improve their overall well-being.

Detailed description: A four-week randomized clinical trial will involve 18 participants, divided randomly into two intervention groups, with nine participants in each group. Group A (intervention group 1) will participate in Swiss ball exercises combined with stretching, while Group B (intervention group 2) will partake in Frenkel exercises along with stretching. The sampling method employed will be a non-probability technique. The Pediatric Balance Scale (PBS) will serve as the primary tool for outcome measurement. Randomization will be conducted using computer-generated software. The study design will be single-blinded, ensuring the assessor remains unaware of the groups\&#39; assignments. Initial data collection (pretest) will occur at week 0, followed by post-test data collection at week 4. For intergroup analysis, if the data follows a normal distribution, the parametric Independent t-test will be utilized, enabling the calculation of mean, standard deviation, and p-values. Alternatively, if the data does not display a normal distribution, the non-parametric Mann-Whitney test will be employed, allowing the calculation of median, interquartile ranges, and p-values.

Eligibility criteria: Inclusion Criteria:

* Patients with having diagnosis of ataxic cerebral palsy
* Age between 5 to 8 years.
* GMFC level 2.
* Both the genders were included

Exclusion Criteria:

* Visual Impairments and hearing loss
* Mental retardation
* Fixed contractures or deformities of the spine or extremities
* Meningitis

Primary outcomes:
measure: Pediatric balance scale(PBS)
timeFrame: 15 to 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah international university
state: Punjab
Study officials:
affiliation: Riphah International Univerisity
name: Rana Ali Raza Shoukat, MS*
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pouliot-Laforte A, Parent A, Hamdy R, Marois P, Lemay M, Ballaz L. Relationship between lower limb strength and walking capacities in children with spastic bilateral cerebral palsy. Disabil Rehabil. 2022 May;44(10):1916-1922. doi: 10.1080/09638288.2020.1813819. Epub 2020 Sep 9.
citation: Elshafey MA, Abdrabo MS, Elnaggar RK. Effects of a core stability exercise program on balance and coordination in children with cerebellar ataxic cerebral palsy. J Musculoskelet Neuronal Interact. 2022 Jun 1;22(2):172-178.