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Clinical Trials/NCT06673797
NCT06673797RecruitingNot Applicable

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

Riphah International University1 site in 1 country18 target enrollmentStarted: September 24, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
18
Locations
1
Primary Endpoint
Pediatric balance scale(PBS)

Study Overview

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' 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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Masking Description

Participant will get separate treatment protocol and possible efforts will be put to mask the both groups about the treatment.

Eligibility Criteria

Ages
5 Years to 8 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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

Experimental

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)

  2. Calf stretching

  3. Hamstring stretches

  4. Quad stretchings

    1. Swiss ball exercises
  5. 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

  6. Sitting on the Swiss ball with trunk straight and arm by the sides.

  7. Standing with gym ball in front.

  8. One leg weight bearing on a gym ball with the therapist behind the patient, gripping the patient's pelvis to provide support

Intervention: Effects of Swiss Ball exercises (Other)

Group B: The second intervention group would participate in Frenkel Exercises along with stretching.

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

  2. Calf stretching

  3. Hamstring stretches

  4. Quads stretching

  5. 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.

Intervention: EFFECTS OF FRENKEL EXERCISES ON STATIC AND DYNAMIC BALANCE IN ATAXIC CHILDREN WITH CEREBRAL PALSY (Other)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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Identifiers

NCT ID
NCT06673797
Other Study IDs
REC/RCR/AHS/24/Ali Raza

Dates

First Submitted
(last year)
First Posted
(last year)
Primary Completion
(last year)
Study Completion
(last year)
Last Verified
(last year)
Last updated
(last year)

Regulatory & Sharing

FDA Regulated Drug
No
FDA Regulated Device
No
IPD Sharing Plan
No
Has Results
No

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