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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06198049
Other study ID # REC/RCR&AHS/23/0735
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date February 15, 2024

Study information

Verified date June 2024
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Static balance is the ability to hold the body in a specific position and posture, while dynamic balance is the ability to maintain balance while moving. Vision, somatosensation, vestibular, and hearing are integrated to achieve balance Ethical committee approval will be obtained. A written consent will be taken from all subjects in the language best understood by them, after fulfilling the inclusion criteria, Patients age 10-14 years will be recruited through Randomized Clinical trial in which convenient sampling technique will be used. Group A 17 participants will receive Pilates training and group B 17 participants will receive balance Proprioception exercises. Pediatric balance scale and Lower Extremity Functional scale will be used .The result after statistical analysis will either show both treatments equally effective or not. Data will be calculated before and after treatment with the help of outcome measure tools.


Description:

Static balance is the ability to hold the body in a specific position and posture, while dynamic balance is the ability to maintain balance while moving. Vision, somatosensation, vestibular, and hearing are integrated to achieve balance. Various strategies are available in physiotherapy for addressing imbalance. Pilates and other balance proprioception exercises may be used as part of a treatment plan, albeit this may vary depending on the etiology of the imbalance. Patients age 10-14 years will be recruited through Randomized Clinical trial in which convenient sampling technique will be used. 34 Participants will be included in this study. Group A 17 participants will receive Pilates exercises, after the initial evaluations, the individuals in the Clinical Pilates training group will be informed about the definition, goals and benefits of clinical Pilates, will be familiarized with the exercises and how to use the five key elements of clinical Pilates (head-neck location - shoulder location - chest cage location - central focus [neutral position] - how they should preserve and maintain breathing) and group B 17 participants will receive balance Proprioception exercises on balance board with different exercises. Pediatric Balance Scale and Lower Extremity Functional scale will be used. The result after statistical analysis will either show both treatments equally effective or not. The results will be analyzed on SPSS.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date February 15, 2024
Est. primary completion date January 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 14 Years
Eligibility Inclusion Criteria - Both Gender will be included. - Age 10-14 years. - No history of lower extremity injuries or neuromuscular problems during the last 6 months - Child's physical fitness level to ensure they can safely participate in Pilates and balance proprioceptive exercises. - Children having Cochlear implant Exclusion Criteria - Patients will be excluded from the study if they had significant cardiac, pulmonary, or metabolic comorbidity or had an active disease that required therapy modification during the study. - If pain will be developed in skeletal muscles after training. - The presence of a neurologic disease, decompensated organ failure, intra-articular steroid injection or surgery in any joint, active synovitis, active arthritis psychiatric disease, and inability to understand and follow the prescribed exercise

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pilates Training
This group will receive Pilates training General rehabilitation exercises. Balance and strengthening exercises. Stretching exercises will be performed.Each exercises will be performed with ten repetition for three sessions per week
Balance Proprioception Exercises
This group will receive balance Proprioception exercises. The training program will consist of 14 basic exercises on and off the balance board, with variations on each exercise. Mat walking time per session increased from 6 to 12 min during the acclimation period of the first two sessions and progressed gradually but incrementally to a maximum of 20 min per session over the 12 ensuing sessions.

Locations

Country Name City State
Pakistan Riphah international university Lahore

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

Mahafza MT, Wilson WJ, Brauer S, Timmer BHB, Hickson L. A Systematic Review of the Effect of Hearing Aids on Static and Dynamic Balance in Adults with Hearing Impairment. Trends Hear. 2022 Jan-Dec;26:23312165221121014. doi: 10.1177/23312165221121014. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pediatric Balance Scale The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills 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. Six weeks
Primary Lower Extremity Functional Scale This consists of 20 questions about a person's capacity to carry out daily chores. Clinicians can use the LEFS to assess patients' initial function, ongoing progress, and outcome, as well as to set functional goals. The maximum score is 80 points, indicating very high function. The minimum possible score is 0 points, indicating very low functions Six weeks
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