NCT06673797

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 24, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 3, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 5, 2024

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2024

Completed
Last Updated

November 5, 2024

Status Verified

November 1, 2024

Enrollment Period

2 months

First QC Date

November 3, 2024

Last Update Submit

November 3, 2024

Conditions

Keywords

Cerebral PalsyAtaxicBalancePediatric balance scaleSwiss ballFrenkel

Outcome Measures

Primary Outcomes (1)

  • Pediatric balance scale(PBS)

    • 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

Study Arms (2)

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) 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

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) 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

Interventions

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

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

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

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

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah international university

Lahore, Punjab Province, 54700, Pakistan

RECRUITING

Related Publications (2)

  • 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.

    PMID: 32905745BACKGROUND
  • 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.

    PMID: 35642697BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Rana Ali Raza Shoukat, MS*

    Riphah International Univerisity

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Asif Javed, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participant will get separate treatment protocol and possible efforts will be put to mask the both groups about the treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2024

First Posted

November 5, 2024

Study Start

September 24, 2024

Primary Completion

November 24, 2024

Study Completion

December 10, 2024

Last Updated

November 5, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations