- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06198049
Effects of Pilates and Balance Proprioception Exercises on Hearing Impairment
January 28, 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
Recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
34
Phase
- 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
- Name: Muhammad Asif Javed, MS
- Phone Number: 923224209422
- Email: a.javed@riphah.edu.pk
Study Contact Backup
- Name: Imran Imran Amjad, Phd
- Phone Number: 9233224390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
-
-
-
Lahore, Pakistan, 54000
- Recruiting
- Riphah International University
-
Contact:
- Imran Amjad, PhD
- Phone Number: 9233224390125
- Email: Imran.amjad@riphah.edu.pk
-
Contact:
- Muhammad Asif Javed, MS
- Phone Number: 923224209422
- Email: a.javed@riphah.edu.pk
-
-
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
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 |
Intervention / Treatment |
---|---|
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.
|
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.
|
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
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
Investigators
- 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.
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)
December 1, 2023
Primary Completion (Estimated)
January 31, 2024
Study Completion (Estimated)
February 15, 2024
Study Registration Dates
First Submitted
December 26, 2023
First Submitted That Met QC Criteria
December 26, 2023
First Posted (Actual)
January 10, 2024
Study Record Updates
Last Update Posted (Actual)
January 30, 2024
Last Update Submitted That Met QC Criteria
January 28, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Hearing Impaired Children
-
Assiut UniversityUnknownHearing Impaired Children
-
Assiut UniversityUnknownHearing Impaired Children
-
Sara Magdy IbrahimAlexandria UniversityCompletedHearing Impaired ChildrenEgypt
-
Amira Mohmed Ahmed BakrAssiut UniversityUnknownHearing Impaired Children
-
The Bionics Institute of AustraliaNot yet recruitingHearing Impaired Children
-
The Bionics Institute of AustraliaNot yet recruiting
-
Riphah International UniversityCompletedHEARING IMPAIRED CHILDRENPakistan
-
University Hospital, GhentUniversitaire Ziekenhuizen KU Leuven; Jessa Hospital; Queen Fabiola Children's... and other collaboratorsCompletedVestibular Disorder | Hearing Impaired ChildrenBelgium
-
Bezmialem Vakif UniversityNuh Naci Yazgan UniversityRecruitingRespiration | Functional Capacity | Hearing Impaired Children | Endurance | Core StabilizationTurkey
Clinical Trials on Pilates Training
-
Universidade Federal de Santa MariaCompleted
-
Aydin Adnan Menderes UniversityCompleted
-
Universidade Federal do vale do São FranciscoCompletedBlood Pressure | Physical Disability | Type-2 Diabetes
-
Riphah International UniversityCompletedMechanical Low Back PainPakistan
-
Riphah International UniversityCompletedPost Partum DepressionPakistan
-
Cairo UniversityRecruiting
-
Chulalongkorn UniversityCompleted
-
Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloCompleted
-
Gazi UniversityCompleted