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IRCT20240306061198N2 IRCT 2024-04-04 The University of Faisalabad Swiss Ball Stabilization Exercises with Trunk Control Spastic Diplegic Cerebral Palsy Children The Effects of Swiss Ball Stabilization Exercises on Trunk Control,Balance,Motor Skill in Spastic Diplegic Cerebral Palsy Children 2024-02-17 anticipated 22 Complete https://irct.ir/trial/76023 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Spastic diplegic Cerebral Palsy. Intervention 1: 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. Intervention 2: Control group: functional electrical stimulation with conservative physical therapy treatment. Yes - There is a plan to make this available What will be shared: 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: 15 days after publication To whom: 15 days after publication Conditions: 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. Where to obtain: The University of Faisalabad 38000 https://tuf.edu.pk/ 0092 41 875 0971-5 Fax: +92 41 875 0970 How to obtain: 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. Comments:
public Dr.Gulraiz Ayub;PT
Faisal Town, West ,Canal Road, Faisalabad, Punjab
Faisalabad Pakistan 38000 0092413170075508 gulraizayub70@gmail.com The University of Faisalabad scientific Dr.Wardah Jabbar
Faisal Town, West ,Canal Road, Faisalabad, Punjab
Faisalabad Pakistan 38000 0092413138650848 wardah.jabbar5@gmail.com The University of Faisalabad Pakistan • 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 3 years 10 years Both • 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 Rehabilitation Rehabilitation 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. Control group: functional electrical stimulation with conservative physical therapy treatment Trunk Control. Timepoint: Baseline intervention and 5 weeks post intervention. Method of measurement: Gross motor function scale GMFS-88. Gross Motor Function. Timepoint: Baseline intervention and 5 weeks post intervention. Method of measurement: GMFS-88. Balance. Timepoint: Baseline intervention and 5 weeks post intervention. Method of measurement: Pediatric berg balance scale. Primitive Reflexes. Timepoint: Baseline intervention and 5 weeks post intervention. Method of measurement: Primitive Reflexes Screening evaluation form positive or negative. The University of Faisalabad Approved 2024-01-05 Research and Ethics/ technical Committee for the University of Faisalabad Faisal Town, West ,Canal Road, Faisalabad, Punjab Faisalabad Punjab Pakistan