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

November 3, 2024 updated by: Riphah International University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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' 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.

Study Type

Interventional

Enrollment (Estimated)

18

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 Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54700
        • Recruiting
        • Riphah International University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rana Ali Raza Shoukat, MS*

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:

  • 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

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:The first intervention group would participate in Swiss ball exercises along with stretching

Group A: The first intervention group would participate in Swiss ball exercises along with stretching as baseline treatment. The exercises would be performed 3 times per week for four weeks. (12)

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

    1. Calf stretching
    2. Hamstring stretches
    3. Quad stretchings

  2. 2. Swiss ball exercises

    1. 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
    2. Sitting on the Swiss ball with trunk straight and arm by the sides.
    3. Standing with gym ball in front.
    4. One leg weight bearing on a gym ball with the therapist behind the patient, gripping the patient's pelvis to provide support
Other: Effects of Swiss Ball exercises

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

  1. Stretching of hamstrings, calf, and quads for 10 seconds hold 5 times.
  2. 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
Experimental: Group B: The second intervention group would participate in Frenkel Exercises along with stretching.

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

    1. Calf stretching
    2. Hamstring stretches
    3. Quads stretching

  2. 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.

    a. Supine lying: i. with the head lifted; Hip abduction and adduction ii. with the head lifted, and one hip and knee extended iii. with the head lifted; and extending one leg to position the heel on the designated spot b. While sitting: i. stretch one leg to the side, bringing the heel to a spot where a mark has been made on the floor.

    ii. Stride sitting; Stand up from a seated position, then return to a seated position.

    c. Stride standing: i. weight transfer from foot to foot. ii. stepping sideways with feet on floor markings. iii. turn around. iv. walking and turning to avoid obstacles.
Other: EFFECTS OF FRENKEL EXERCISES ON STATIC AND DYNAMIC BALANCE IN ATAXIC CHILDREN WITH CEREBRAL PALSY

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.

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

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

  2. 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)

    1. Supine lying
    2. While sitting
    3. Stride standing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 to 20 minutes

Collaborators and Investigators

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

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Rana Ali Raza Shoukat, MS*, Riphah International Univerisity

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)

September 24, 2024

Primary Completion (Estimated)

November 24, 2024

Study Completion (Estimated)

December 10, 2024

Study Registration Dates

First Submitted

November 3, 2024

First Submitted That Met QC Criteria

November 3, 2024

First Posted (Estimated)

November 5, 2024

Study Record Updates

Last Update Posted (Estimated)

November 5, 2024

Last Update Submitted That Met QC Criteria

November 3, 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/Ali Raza

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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