Hearing Impaired ChildrenNCT06198049
Effects of Pilates and Balance Proprioception Exercises on Hearing Impairment
A study testing Pilates Training and Balance Proprioception Exercises in people with Hearing Impaired Children, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Impaired Children
- What is being tested?
- Pilates Training and Balance Proprioception Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2023to 15 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hearing Impaired Children
- Being tested
- Pilates Training, Balance Proprioception Exercises
- Keywords
- Hearing Impairment, Balance, Pilates
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates TrainingOther
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 ExercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pilates Training | Experimental | 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. Receives: Other: Pilates Training |
| Balance Proprioception Exercises | Experimental | 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. Receives: Other: Balance Proprioception Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six weeks
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
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Dec 2023
- Primary completion31 Jan 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing Impaired ChildrenStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be Randomized Clinical Trial to see the effect of Pilates Training versus Balance Proprioception exercises on lower extremity function in children with hearing impairment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iqra khan, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198049
- Sponsor's protocol ID
- REC/RCR&AHS/23/0735
- Status last verified
- Jun 2024
- First submitted
- 26 Dec 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36377351
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pilates Training Versus Balance Proprioception Exercises on Lower Extremity Function in Children With Hearing Impairment
- ClinicalTrials.gov ID
- NCT06198049
- Acronym / sponsor ID
- REC/RCR&AHS/23/0735
- Conditions
- Hearing Impaired Children
- Keywords
- Hearing Impairment, Balance, Pilates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This will be Randomized Clinical Trial to see the effect of Pilates Training versus Balance Proprioception exercises on lower extremity function in children with hearing impairment
| Arm | Type | Receives |
|---|---|---|
| Pilates Training | Experimental | Other: Pilates TrainingGroup 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. |
| Balance Proprioception Exercises | Experimental | Other: Balance Proprioception ExercisesGroup 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. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilates TrainingThis 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 | Other | Pilates Training |
| Balance Proprioception ExercisesThis 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. | Other | Balance Proprioception Exercises |
Primary outcome
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Background: PubMed 36377351Mahafza 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.
- Individual participant dataSharing planned: No
Related trials for Hearing Impaired Children
Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
Hearing Loss, Bilateral
RecruitingObservational study
Audiological Rehabilitation of Children With Unilateral Hearing Loss
Unilateral Hearing Loss
Not yet recruiting
Artificial Grammar Learning in Children Who Are Deaf or Hard-of-Hearing: Stimulus Length Effect
Hearing Impaired Children
Recruiting
Evaluation of Cochlear Implantation in Unilateral or Asymmetric Hearing Loss in Children.
Unilateral Hearing Loss, Asymmetric Hearing Loss
Recruiting
Towards Implementation of Universal Newborn Hearing Screening in Kenya
Hearing Loss, Bilateral or Unilateral, Otitis Media With Effusion in Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iqra khan, MS* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates Training and Balance Proprioception Exercises in people with Hearing Impaired Children, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Balance Scale (time frame: Six weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06198049, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.