The purpose of this study to check the effects of Swiss ball stabilization exercises on trunk control ,balance,motor skill in spastic diplegic cerebral palsy children and to evaluate the trunk control in children with spastic diplegic cerebral palsy and to measure the functional performance by using Pediatric berg balance scale. (PBBS).
Design
Randomized Clinical trial , Single Blinded, Parallel group
Settings and conduct
The Children Hospital & Institute of Child Health Faisalabad
Participants/Inclusion and exclusion criteria
inclusion
• Child age with 3-10 years. • Both gender male and female. • Child able to follow verbal command. • Children with GMFS level (II, III, IV) • Children with Modified Ashworth scale (0-2) • Pediatric balance scale more than 20 score
exclusion
• Children who were uncooperative • Children who have visual and intellectual impairments • Use of anti-epileptic & anti-spasticity medications • CP include (Hemiplegic CP, Quadriplegic CP, Ataxic CP, Athetoid CP, Mixed CP, Hypotonic CP) • With any Hearing deficit • Sensory loss • Tumors • Children with severe mental abnormality • Any cardiac anomalies affecting exercise tolerance • Less than 4 months after undergoing orthopedic surgery • Usage of botulism toxins Injections • With any bony Malalignment and Contractures
Intervention groups
As a baseline treatment functional electrical stimulation was done. Then the Swiss ball stabilization exercises were applied. Swiss Ball Stabilization Exercises
Main outcome variables
The Trunk Control Gross Motor Function Scale-88 Pediatric Berg Balance Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240306061198N2
Registration date:2024-04-04, 1403/01/16
Registration timing:registered_while_recruiting
Last update:2024-04-04, 1403/01/16
Update count:0
Registration date
2024-04-04, 1403/01/16
Registrant information
Name
Syed Saqlain Babar
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 41 87509715
Email address
2022-ms-pt-044@tuf.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-17, 1402/11/28
Expected recruitment end date
2024-03-24, 1403/01/05
Actual recruitment start date
2024-02-17, 1402/11/28
Actual recruitment end date
2024-04-24, 1403/02/05
Trial completion date
2024-04-26, 1403/02/07
Scientific title
The Effects of Swiss Ball Stabilization Exercises on Trunk Control,Balance,Motor Skill in Spastic Diplegic Cerebral Palsy Children
Public title
Swiss Ball Stabilization Exercises with Trunk Control Spastic Diplegic Cerebral Palsy Children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
• Child age with 3-10 years
• Both gender male and female
• Child able to follow verbal command
• Children with GMFS level (II, III, IV)
• Children with Modified Ashworth scale (0-2)
• Pediatric balance scale more than 20 score
Exclusion criteria:
• Children who were uncooperative
• Children who have visual and intellectual impairments
• Use of anti-epileptic & anti-spasticity medications
• CP include (Hemiplegic CP, Quadriplegic CP, Ataxic CP, Athetoid CP, Mixed CP, Hypotonic CP)
• With any Hearing deficit
• Sensory loss
• Tumors
• Children with severe mental abnormality
• Any cardiac anomalies affecting exercise tolerance
• Less than 4 months after undergoing orthopedic surgery
• Usage of botulism toxins Injections
• With any bony Malalignment
• Contractures
Age
From 3 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
22
Actual sample size reached:
21
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization will be done with the help of Chit & Draw method. Chit: A chit is a small piece of paper or token, often with a number or other identifier written on it. In randomization processes involving chits, each chit represents a specific outcome or option. Chits are typically placed into a container, such as a hat or a bowl, and then drawn at random to determine the outcome. This method ensures randomness because each chit has an equal chance of being selected. Draw: Drawing is the action of randomly selecting a chit or card from a container. In this method, a person reaches into the container without looking and selects one item (chit or card) at random. The selected item determines the outcome of the randomization process. Drawing is often used in situations where physical objects like chits, cards, or tokens are involved. Both chit and draw methods are straightforward and widely used for generating random outcomes in various contexts, from simple games to more complex decision-making processes. They provide a fair and unbiased way to select from a set of options without any predetermined
Blinding (investigator's opinion)
Single blinded
Blinding description
Single Blinded: outcome assessors are typically kept unaware of which participants received the experimental treatment and which received the comparative intervention. This blinding helps to prevent conscious or unconscious biases that could influence the assessment of study outcomes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research and Ethics/ technical Committee for the University of Faisalabad
Street address
Faisal Town, West ,Canal Road, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Approval date
2024-01-05, 1402/10/15
Ethics committee reference number
TUF/Addl Reg/SB/656
Health conditions studied
1
Description of health condition studied
Spastic diplegic Cerebral Palsy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Trunk Control
Timepoint
Baseline intervention and 5 weeks post intervention
Method of measurement
Gross motor function scale GMFS-88
2
Description
Gross Motor Function
Timepoint
Baseline intervention and 5 weeks post intervention
Method of measurement
GMFS-88
Secondary outcomes
1
Description
Balance
Timepoint
Baseline intervention and 5 weeks post intervention
Method of measurement
Pediatric berg balance scale
2
Description
Primitive Reflexes
Timepoint
Baseline intervention and 5 weeks post intervention
Method of measurement
Primitive Reflexes Screening evaluation form positive or negative
Intervention groups
1
Description
Intervention group 1: Functional Electrical Stimulation with Swiss Ball Stabilization Exercises As a baseline treatment, functional electrical stimulation was done. Then the Swiss ball stabilization exercises were applied. Swiss Ball Stabilization Exercises Each participant performed exercise using a Swiss ball for 25 minutes in two postures, prone and sitting. First, the prone posture will used one way, “To and FRO,” with sway accompanied volitional upper extremity extension like superman for 5 minutes. Second, the sitting posture will used to perform the “Up and Down,” “To and Fro,” and “Spinning” movements. Each session lasted 5 minutes, and the participants were instructed to perform rhythmical movements. Optimal arousal Swiss ball Make the child bounce, active/passive on the Swiss ball, slow/fast 5 times 5 sets .Combined frontal and transverse plane movements Swiss ball High sitting: one-handed weight bearing followed by trunk rotation to reach the toy on opposite side 5-7 times each side 1 set . Trunk activation activities Swiss ball High sitting foot placed on the ground: throwing the ball with both hands. 5 times, 1 set. Roll the ball maximum backward and hold for 10 seconds, keeping pelvis in neutral, knee in extension, and the foot in plantar flexion 5 times, 1 set 5. Dynamic trunk activities in sitting (transverse and frontal plane) Swiss ball Reaching the toy sideways with one hand by shifting the body weight toward the reaching side 5 times each one set Reaching the toy with both the hands kept a little back with trunk rotation toward the reaching side 5 times each side, 1 set .Prone posture was applied on way to & FRO & spinning with sway, accompanied by volitional upper extremity like Superman. 5 times, 1 set. Pressure time with a therapy ball Front & back pressure 3 times 1 set.
Category
Rehabilitation
2
Description
Control group: functional electrical stimulation with conservative physical therapy treatment
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Children Hospital & Institute of Child Health ,Faisalabad
Full name of responsible person
Dr.Syed Saqlain Babar; PT
Street address
Faisal Town, West ,Canal Road, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Phone
+92 41 9203065
Email
2022-ms-pt-044@tuf.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr.Zainab Boota PT
Street address
Faisal Town, West ,Canal Road, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Phone
+92 335 7916317
Email
zainboota9698@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The Effects of Swiss Ball Stabilization Exercises on Trunk Control,Balance,Motor Skill in Spastic Diplegic Cerebral Palsy Children.Data was assembled with respect to muscle tone measured by Modified Ashworth Scale (Grade 0-2), Gross Motor Function Classification System (GMFCS) Grade (II, III, IV), a Gross Motor Function-88 Questionnaires to assessed trunk control and motor skill & balance assessed by PBBS more than 20 as outcome measure tools.
When the data will become available and for how long
15 days after publication
To whom data/document is available
15 days after publication
Under which criteria data/document could be used
Access to the data will be facilitated through a specified mechanism, such as a secure online portal or data sharing platform. Requests for access will be reviewed by a designated committee or entity responsible for ensuring that they meet the established criteria and comply with relevant regulations and guidelines. Additional supporting information and documents may be provided to assist requesters in understanding the available data and its potential applications.
From where data/document is obtainable
The University of Faisalabad 38000 https://tuf.edu.pk/ 0092 41 875 0971-5 Fax: +92 41 875 0970
What processes are involved for a request to access data/document
To receive the documents or data files, the process typically involves the following steps: 1. Request Initiation: The applicant submits a formal request specifying the documents or data files they need. 2. Verification and Authorization: The organization verifies the request and ensures that the applicant is authorized to access the requested documents or data files. This may involve confirming the identity of the requester and checking their permissions. 3. Processing Time: The processing time varies depending on the complexity of the request, the volume of documents or data files, and any legal or regulatory requirements. It could range from a few hours to several weeks. 4. Document Retrieval or Data Extraction: Once the request is approved, the organization retrieves the documents from their archives or extracts the requested data from their databases. 5. Quality Assurance: Before releasing the documents or data files to the applicant, the organization may conduct quality checks to ensure accuracy and completeness. 6. Delivery: The documents or data files are delivered to the applicant through a secure channel, such as encrypted email, secure file transfer protocols, or a secure online portal. 7. Confirmation of Receipt: The applicant acknowledges receipt of the documents or data files, confirming that they have received the information they requested.