Hearing DisordersNCT05719610
Effects of Cawthorne Cooksey Exercises on Balance in Children With Hearing Deficits
A study testing Cawthorne Cooksey Exercises for Balance Training and Swiss Ball Exercises in people with Hearing Disorders, run by Riphah International University at 1 site in Pakistan.
Trial summary
Balance and weak postural control are most common in children with severe to profound hearing deficits. Children with hearing deficits also indicate behavioral problems related to impulse control, distraction, and disability to maintain attention in the visual modality. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Disorders
- What is being tested?
- Cawthorne Cooksey Exercises for Balance Training and Swiss Ball Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Jan 2023to 3 Jul 2023
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with age between 7 to 12 yeas
- Children with diagnosed sensorineural hearing deficits (PTA >90db)
- Children with normal vision
Who cannot join
- Children with any orthopedic and neurological impairments
- Children taking medications that affect central nervous system
- In the case of being absent from more than two sessions, non-cooperation of the family, and the occurrence of orthopedic accidents and if diseases prevented the patient from participation
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Government Secondary School of Special Education for Deaf, Main Gulberg Lahore.
Lahore, Punjab Province, 50700
About this study
Official title: Effects of Cawthorne Cooksey Exercises on Balance and Quality of Life in Children With Hearing Deficits
Balance and weak postural control are most common in children with severe to profound hearing deficits. Children with hearing deficits also indicate behavioral problems related to impulse control, distraction, and disability to maintain attention in the visual modality. Hearing deficit is mostly defined as a communication deficit. Although the communication deficit is an important disorder, hearing deficit co-occurs with other physical impairments such as vestibular disorders. Development and control of the posture are important prerequisites for skill motor function. Children with hearing deficits and impaired sensory organization had weak balance and motor efficiency in many fields. Various studies on motor skills in deaf children have reported deficits in balance, general dynamic coordination, visual-motor skills, ball catching ability, and some disturbances in reaction time and speed of movements. Teachers of children with hearing impairment often complain of non-coordination, clumsiness, and balance deficit in such children, preventing the child from the desired function. So the aim of the study is to determine the effects of Cawthorne Cooksey Exercises on Balance and quality of life in children with hearing deficit It will be a Randomized Controlled Trial and children fulfilling exclusion-inclusion criteria will participate in the study. They will be divided randomly into two groups, using computer generated randomization, into control group and experimental group. After performing the pre-test measurements, the control group will perform Swiss Ball Exercises for 45 minutes and the interventional group will perform Cawthorne Cooksey Training Program Swiss Ball Exercises in addition, will also perform of 45 min session three times a week for 8 weeks of training. the study subjects will be evaluated again by Pediatrics Berg Balance Scale, Four-Step Square test and Quality of life questionnaire for children to measure the quality of life. Results will be compared with the pretest measurements. Data will be analyzed by using SPSS scale windows software version 25.
Read the detailed description
In children, vestibular function plays an important role in the gross motor development and postural control. Infants and children with congenitally profound hearing loss commonly suffer vestibular dysfunction in both ears, and poor balance. However, there have been very few studies have investigated the effect of exercises on balance and quality of life in children with the profound hearing deficit. The development and maintenance of balance is a multisystem process that also depends on vestibular input believe that as labyrinths and cochlea are anatomically and developmentally interrelated, there is a potentiality for vestibular impairment when the hearing mechanism is impaired.
In a study using Barany Rotary test and caloric stimulation, found that 82% of 89 children with severe acquired hearing deficits and 34% of 129 children with hereditary hearing deficits had abnormal responses to vestibular tests. Since the vestibular system activates vestibular reflex mechanisms trying to stabilize the eyes, head, and body in the space, impairment of this mechanism may affect postural sensitivity. Maturational changes in visual and proprioceptive, central nervous system processing, and coordination of motor output are responsible for the changes in postural skills observed through adolescence . From the sensory systems perspective, Infants and young children are dependent on the visual system to maintain balance; as they grow older, begin to use somatosensory and vestibular information appropriately. Between the 3 sensory inputs in children, the vestibular system seems to be the least effective in postural control.
Children with profound bilateral vestibular dysfunction present with delayed gross motor development. These children stand and walk later than their peers with typical development Difficulties in maintaining balance can lead to challenges in normal childhood activities, such as riding a bicycle or hopping. Reduced ability to participate in normal play with other children may result in social isolation. So, the mechanisms responsible for the lack of balance in children with profound hearing impairment need to be established, and holistic management including both auditory and vestibular function is needed. Sensory organization dysfunction is more prevalent in children with hearing loss and vestibular dysfunction which may result in a problem with balance. These children in situations needs an early address to their balance through balance training activities. Most children with bilateral vestibular dysfunction. These results suggest that due to multi-modal sensory interdependence, the development of visual and somatosensory effectiveness in maintaining balance is impaired secondary to vestibular dysfunction since birth. There is ample support for the efficacy of vestibular rehabilitation therapy through different exercises in adults, but very few data exist regarding its results in children.
Balance is major problem associated with vestibular system specifically in the patients with sensory neural hearing deficits. Since vestibular rehabilitation is an important factor that must be achieved for balance in hearing deficits. Cawthorne Cooksey exercises may be considered as an effective technique to gain balance and improve quality of life.
- Conditions
- Hearing Disorders
- Being tested
- Cawthorne Cooksey Exercises for Balance Training, Swiss Ball Exercises
- Medical subject headings
- Hearing Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cawthorne Cooksey Exercises for Balance TrainingOther
Group of Exercises used to Increase balance
Swiss Ball ExercisesOther
Swiss Ball Exercises
| Study group | Role | What they receive |
|---|---|---|
| Cawthorne Cooksey Exercises | Experimental | Not described Receives: Other: Cawthorne Cooksey Exercises for Balance Training |
| Swiss Ball Exercises | Experimental | Not described Receives: Other: Swiss Ball Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Berg Balance Scale
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: 12 weeks
Secondary outcomes (1)
Four-step square test
the FSST has been widely used in neurological populations3-5 and also in musculoskeletal conditions such as joint replacements, arthritis, osteoporosis, orthotic design for lower extremity trauma and amputees. The FSST requires a stopwatch and four single point sticks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start27 Jan 2023
- Primary completion1 Jun 2023
- Study completion3 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing DisordersStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Khan, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719610
- Sponsor's protocol ID
- REC/RCR&AHS/22/0731
- Status last verified
- Jul 2023
- First submitted
- 31 Jan 2023
- Last updated
- 10 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cawthorne Cooksey Exercises on Balance and Quality of Life in Children With Hearing Deficits
- ClinicalTrials.gov ID
- NCT05719610
- Acronym / sponsor ID
- REC/RCR&AHS/22/0731
- Conditions
- Hearing Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 27 Jan 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 3 Jul 2023 (actual)
- First posted
- 9 Feb 2023 (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.
Balance and weak postural control are most common in children with severe to profound hearing deficits. Children with hearing deficits also indicate behavioral problems related to impulse control, distraction, and disability to maintain attention in the visual modality. Hearing deficit is mostly defined as a communication deficit. Although the communication deficit is an important disorder, hearing deficit co-occurs with other physical impairments such as vestibular disorders. Development and control of the posture are important prerequisites for skill motor function. Children with hearing deficits and impaired sensory organization had weak balance and motor efficiency in many fields. Various studies on motor skills in deaf children have reported deficits in balance, general dynamic coordination, visual-motor skills, ball catching ability, and some disturbances in reaction time and speed of movements. Teachers of children with hearing impairment often complain of non-coordination, clumsiness, and balance deficit in such children, preventing the child from the desired function. So the aim of the study is to determine the effects of Cawthorne Cooksey Exercises on Balance and quality of life in children with hearing deficit It will be a Randomized Controlled Trial and children fulfilling exclusion-inclusion criteria will participate in the study. They will be divided randomly into two groups, using computer generated randomization, into control group and experimental group. After performing the pre-test measurements, the control group will perform Swiss Ball Exercises for 45 minutes and the interventional group will perform Cawthorne Cooksey Training Program Swiss Ball Exercises in addition, will also perform of 45 min session three times a week for 8 weeks of training. the study subjects will be evaluated again by Pediatrics Berg Balance Scale, Four-Step Square test and Quality of life questionnaire for children to measure the quality of life. Results will be compared with the pretest measurements. Data will be analyzed by using SPSS scale windows software version 25.
Detailed description
In children, vestibular function plays an important role in the gross motor development and postural control. Infants and children with congenitally profound hearing loss commonly suffer vestibular dysfunction in both ears, and poor balance. However, there have been very few studies have investigated the effect of exercises on balance and quality of life in children with the profound hearing deficit. The development and maintenance of balance is a multisystem process that also depends on vestibular input believe that as labyrinths and cochlea are anatomically and developmentally interrelated, there is a potentiality for vestibular impairment when the hearing mechanism is impaired.
In a study using Barany Rotary test and caloric stimulation, found that 82% of 89 children with severe acquired hearing deficits and 34% of 129 children with hereditary hearing deficits had abnormal responses to vestibular tests. Since the vestibular system activates vestibular reflex mechanisms trying to stabilize the eyes, head, and body in the space, impairment of this mechanism may affect postural sensitivity. Maturational changes in visual and proprioceptive, central nervous system processing, and coordination of motor output are responsible for the changes in postural skills observed through adolescence . From the sensory systems perspective, Infants and young children are dependent on the visual system to maintain balance; as they grow older, begin to use somatosensory and vestibular information appropriately. Between the 3 sensory inputs in children, the vestibular system seems to be the least effective in postural control.
Children with profound bilateral vestibular dysfunction present with delayed gross motor development. These children stand and walk later than their peers with typical development Difficulties in maintaining balance can lead to challenges in normal childhood activities, such as riding a bicycle or hopping. Reduced ability to participate in normal play with other children may result in social isolation. So, the mechanisms responsible for the lack of balance in children with profound hearing impairment need to be established, and holistic management including both auditory and vestibular function is needed. Sensory organization dysfunction is more prevalent in children with hearing loss and vestibular dysfunction which may result in a problem with balance. These children in situations needs an early address to their balance through balance training activities. Most children with bilateral vestibular dysfunction. These results suggest that due to multi-modal sensory interdependence, the development of visual and somatosensory effectiveness in maintaining balance is impaired secondary to vestibular dysfunction since birth. There is ample support for the efficacy of vestibular rehabilitation therapy through different exercises in adults, but very few data exist regarding its results in children.
Balance is major problem associated with vestibular system specifically in the patients with sensory neural hearing deficits. Since vestibular rehabilitation is an important factor that must be achieved for balance in hearing deficits. Cawthorne Cooksey exercises may be considered as an effective technique to gain balance and improve quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cawthorne Cooksey Exercises | Experimental | Other: Cawthorne Cooksey Exercises for Balance Training |
| Swiss Ball Exercises | Experimental | Other: Swiss Ball Exercises |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children with age between 7 to 12 yeas
- Children with diagnosed sensorineural hearing deficits (PTA >90db)
- Children with normal vision
Key exclusion criteria (3 listed)
- Children with any orthopedic and neurological impairments
- Children taking medications that affect central nervous system
- In the case of being absent from more than two sessions, non-cooperation of the family, and the occurrence of orthopedic accidents and if diseases prevented the patient from participation
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 |
|---|---|---|
| Cawthorne Cooksey Exercises for Balance TrainingGroup of Exercises used to Increase balance | Other | Cawthorne Cooksey Exercises |
| Swiss Ball ExercisesSwiss Ball Exercises | Other | Swiss Ball Exercises |
Primary outcome
Pediatric Berg Balance Scale
Time frame: 12 weeks
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
1 secondary outcome
Four-step square test
Time frame: 12 weeks
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 10 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Sara 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 Cawthorne Cooksey Exercises for Balance Training and Swiss Ball Exercises in people with Hearing Disorders, 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 3 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 10 Jul 2023. 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 Berg Balance Scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2023.