Effects of Pilates and Balance Proprioception Exercises on Hearing Impairment

June 11, 2024 updated by: Riphah International University

Effects of Pilates Training Versus Balance Proprioception Exercises on Lower Extremity Function in Children With Hearing Impairment

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
      • Lahore, Pakistan, 54000
        • Riphah International University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pilates Training
Group A 17 participants 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.
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
Experimental: Balance Proprioception Exercises
Group B 17 participants 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. The program will be included four prescribed exercises: (a) exercise without any material, (b) exercise with a ball only, (c) exercise with a balance board only, and (d) exercise with a ball and a balance board. Also for gait and dynamic balance activity training use of Cobblestones walking mat that affects postural control. Walking task on the Cobblestone walking mat included: walking backward, walking sideways, and walking under dim light conditions. 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pediatric Balance Scale
Time Frame: Six weeks
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
Lower Extremity Functional Scale
Time Frame: Six weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Iqra khan, MS*, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/RCR&AHS/23/0735

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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