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NCT Number: NCT06673797

Effects of Swiss Ball vs Frenkle Exercises on Static and Dynamic Balance in Ataxic CP

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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' 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Effects of Swiss Ball exercises

Other

Effects of Swiss ball exercises along with stretching as baseline treatment.

  • Stretching of hamstrings, calf, and quads for 10 seconds hold 5 times.
  • Swiss ball exercises. a.Sitting on the Swiss ball with the trunk straight, arms by the sides, and eyes opened progressed towards eyes closed for 10 seconds, then rest. b.Sitting on the Swiss ball with trunk straight and arm by the sides. The therapist would assist the patient to engage the patient in shifting the body's weight to one side and the other side sideways as well as anterior and posterior and up and down alternatively. Start with 10 repetitions. c. Standing with gym ball in front. The therapist would stand behind the patient to provide support and ask the patient to lean forward on the gym ball with both hands via outstretched arms. Start with 10 repetitions d. One leg weight bearing on a gym ball with the therapist behind the patient, gripping the patient's pelvis to provide support. Start with 10 repetitions

EFFECTS OF FRENKEL EXERCISES ON STATIC AND DYNAMIC BALANCE IN ATAXIC CHILDREN WITH CEREBRAL PALSY

Other

Frenkel Exercises along with stretching as baseline treatment. The second intervention group would participate in Frenkel Exercises along with stretching as baseline treatment. The exercises would be performed 3 times per week for four weeks.

  • Stretching of hamstrings, calf, and quads for 10 seconds hold 5 times. (11)

a. Calf stretching. b. Hamstring stretches. c. Quads stretching

  • Frenkel's lower limb exercises are the exercises listed below. The time of each session was set to be 10 minutes in the first week and then raised by 5 minutes every week. The patients were given 5 minutes to relax after 10 minutes of practice. (12)
  • Supine lying
  • While sitting
  • Stride standing

Primary outcomes

  1. Pediatric balance scale(PBS)

    Time frame: 15 to 20 minutes

    • Pediatric balance scale (PBS): It is a modified version of the Berg Balance Scale that is used to assess functional (static and dynamic) balance skills before and after exercises in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points. The PBS has a test-retest reliability of ICC=0.998 and a good interrater reliability of ICC=0.997.

Study contacts

Contact information is provided by the study sponsor or research team.

Imran Amjad, PhD

CONTACT

[email protected]

9233224390125

Muhammad Asif Javed, MS

CONTACT

[email protected]

03224209422

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Swiss Ball vs Frenkle Exercises on Static and Dynamic Balance in Ataxic Children With Cerebral Palsy

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 5, 2024
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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