Balance AssessmentNCT06673836
Comparative Study of Inclined Treadmill and Dynamic Cycling on Balace in Hearing Impaired Children.
A study testing DYNAMIC CYCLING and INCLINED TREAD MILL in people with Balance Assessment, run by Riphah International University at 1 site in Pakistan.
Trial summary
Hearing loss is generally identified initially in life leading to difficulties in communication. In children, vestibular dysfunctions can cause a deficit in gross motor development and balance stability. Read more about this study
- Who is it for?
- Ages 8 to 10 years
- Conditions the study is for
- Balance Assessment
- What is being tested?
- DYNAMIC CYCLING and INCLINED TREAD MILL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Sep 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- children with any acute or chronic disease recurrent falls history of any MSK disease
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Riphah International University
Lahore, Punjab Province, 54000
Imran Amjad, PhD, 9233224390125, Imran.amjad@riphah.edu.pk
Muhammad Asif Javed, MS, a.javed@riphah.edu.pk
About this study
Official title: Comparative Effect of Inclined Treadmill and Dynamic Cycling on Balance and Gait in Children With Hearing Impairment.
Hearing loss is generally identified initially in life leading to difficulties in communication. In children, vestibular dysfunctions can cause a deficit in gross motor development and balance stability. At an early age, delayed gross motor development can cause impairment in the bilateral vestibular system and sensorineural hearing. The children with balance impairment cannot usually participate in physical activities. Running, cycling, hoping and leading to social isolation3. In Pakistan, 2.49% of the population suffers from some disability; the hearing loss population is 7.4%. In Pakistan, hearing loss is more reported in males as compared to females. According to the non-official data, nearly 1.2 in every 1000 Pakistani children suffer from moderate to severe bilateral hearing loss5. In this, 15% population is suffering from profound and nearly 85% from moderate to severe hearing loss.Children who have vestibular dysfunctions may experience many disorders of the vestibular system.Acute unilateral vestibular loss (AUVL) is the most frequent vestibular dysfunction. The etiology of acute unilateral vestibular loss is unknown, but the studies say it may be due to genetic and acquired causes (inflammatory and viral infections). The symptoms include static
Read the detailed description
This study seeks to provide a detailed understanding of the effects of dynamic cycling and inclined treadmill training on the motor skills of children with hearing impairments through an extensive review of relevant literature, careful data collection, and robust statistical analysis. The findings may assist parents, educators, and healthcare professionals in making informed choices about the most effective therapies to enhance mobility and overall development in children with hearing impairments. Ultimately, this research contributes to pediatric rehabilitation and promotes a holistic approach to addressing the specific needs of children with hearing loss.
- Conditions
- Balance Assessment
- Being tested
- DYNAMIC CYCLING, INCLINED TREAD MILL
- Keywords
- balance, dynamic cycling, gait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DYNAMIC CYCLINGDevice
Also called Balance Training: Exercises focused on improving coordination and balance, such as standing on one leg, walking on uneven surfaces, or using balance boards. Core Strengthening: Strengthening core musc, inclined treadmill training is a powerful tool for addressing the balance and gait challenges faced by hearing-impaired children. Through gradual and progressive training, this intervention helps to s
Balance Training: Exercises focused on improving coordination and balance, such as standing on one leg, walking on uneven surfaces, or using balance boards.
Core Strengthening: Strengthening core muscles helps children maintain stability during dynamic movements, such as walking or running.
Proprioceptive Training: Exercises that improve awareness of the body's position in space, such as obstacle courses or activities that challenge movement coordination.
INCLINED TREAD MILLDevice
Also called dynamic cyling
Dynamic Cycling: Refers to the fluctuating nature of movement patterns, often used in therapies like stationary biking or recumbe.nt cycling, where the intensity and resistance vary. Dynamic cycling can also refer to training that involves alternating between high and low-intensity phases or cycling between different positions (sitting, standing) or speeds during the activity
| Study group | Role | What they receive |
|---|---|---|
| dynamic cycling | Experimental | one group will perform dynamic cycling for 6 consecutive weeks,3 days a week for 30 minutes per session. Receives: Device: DYNAMIC CYCLING |
| inclined treadmill | Experimental | one group will perform treadmil for 3 days a week with 10 degree inclination for 6 six consecutive weeks. Receives: Device: INCLINED TREAD MILL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic gate index
The Dynamic Gait Index was developed by Anne Shumway-Cook (1995) and has been used with older adults to determine their likelihood of falling. Scores of 19 and less are related to falls in older adults. It tests 8 facets of gait and can be used with an assistive device.
Measured: 10-15 min
CTSIB TEST
The test is the therapist\'s version of the Computerized Dynamic Post urography which attempts to measure the way that vision, Vestibular and somatosensory interaction allows us to maintain our balance against the forces of gravity. The test was developed by Shumway Cook and Horak in 1986 and further discussed as a clinical tool in 1987 Patients with uncompensated unilateral vestibular deficits have been shown to have difficulty when visual and support surface information are manipulated.
Measured: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start27 Sep 2024
- Primary completion28 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
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 Balance AssessmentStudies 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
- parallal assignment. it will be randomized controlled study,in which probability convenient sampling will be usd.two groups of hearing impaired children will be randomly divided.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asra Ghafoor, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673836
- Sponsor's protocol ID
- REC/RCR/AHS/24/ASRA GHAFOOR
- Status last verified
- Nov 2024
- First submitted
- 3 Nov 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Strader DB, Wright T, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C. Hepatology. 2004 Apr;39(4):1147-71. doi: 10.1002/hep.20119. No abstract available.
PubMed 15057920
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Inclined Treadmill and Dynamic Cycling on Balance and Gait in Children With Hearing Impairment.
- ClinicalTrials.gov ID
- NCT06673836
- Acronym / sponsor ID
- REC/RCR/AHS/24/ASRA GHAFOOR
- Conditions
- Balance Assessment
- Keywords
- balance, dynamic cycling, gait
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- 28 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 5 Nov 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.
Hearing loss is generally identified initially in life leading to difficulties in communication. In children, vestibular dysfunctions can cause a deficit in gross motor development and balance stability. At an early age, delayed gross motor development can cause impairment in the bilateral vestibular system and sensorineural hearing. The children with balance impairment cannot usually participate in physical activities. Running, cycling, hoping and leading to social isolation3. In Pakistan, 2.49% of the population suffers from some disability; the hearing loss population is 7.4%. In Pakistan, hearing loss is more reported in males as compared to females. According to the non-official data, nearly 1.2 in every 1000 Pakistani children suffer from moderate to severe bilateral hearing loss5. In this, 15% population is suffering from profound and nearly 85% from moderate to severe hearing loss.Children who have vestibular dysfunctions may experience many disorders of the vestibular system.Acute unilateral vestibular loss (AUVL) is the most frequent vestibular dysfunction. The etiology of acute unilateral vestibular loss is unknown, but the studies say it may be due to genetic and acquired causes (inflammatory and viral infections). The symptoms include static
Detailed description
This study seeks to provide a detailed understanding of the effects of dynamic cycling and inclined treadmill training on the motor skills of children with hearing impairments through an extensive review of relevant literature, careful data collection, and robust statistical analysis. The findings may assist parents, educators, and healthcare professionals in making informed choices about the most effective therapies to enhance mobility and overall development in children with hearing impairments. Ultimately, this research contributes to pediatric rehabilitation and promotes a holistic approach to addressing the specific needs of children with hearing loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- parallal assignment. it will be randomized controlled study,in which probability convenient sampling will be usd.two groups of hearing impaired children will be randomly divided.
| Arm | Type | Receives |
|---|---|---|
| dynamic cycling | Experimental | Device: DYNAMIC CYCLINGone group will perform dynamic cycling for 6 consecutive weeks,3 days a week for 30 minutes per session. |
| inclined treadmill | Experimental | Device: INCLINED TREAD MILLone group will perform treadmil for 3 days a week with 10 degree inclination for 6 six consecutive weeks. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- children with any acute or chronic disease recurrent falls history of any MSK disease
- -
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 |
|---|---|---|
| DYNAMIC CYCLINGAlso: Balance Training: Exercises focused on improving coordination and balance, such as standing on one leg, walking on uneven surfaces, or using balance boards. Core Strengthening: Strengthening core musc, inclined treadmill training is a powerful tool for addressing the balance and gait challenges faced by hearing-impaired children. Through gradual and progressive training, this intervention helps to sBalance Training: Exercises focused on improving coordination and balance, such as standing on one leg, walking on uneven surfaces, or using balance boards. Core Strengthening: Strengthening core muscles helps children maintain stability during dynamic movements, such as walking or running. Proprioceptive Training: Exercises that improve awareness of the body's position in space, such as obstacle courses or activities that challenge movement coordination. | Device | dynamic cycling |
| INCLINED TREAD MILLAlso: dynamic cylingDynamic Cycling: Refers to the fluctuating nature of movement patterns, often used in therapies like stationary biking or recumbe.nt cycling, where the intensity and resistance vary. Dynamic cycling can also refer to training that involves alternating between high and low-intensity phases or cycling between different positions (sitting, standing) or speeds during the activity | Device | inclined treadmill |
Primary outcome
Dynamic gate index
Time frame: 10-15 min
The Dynamic Gait Index was developed by Anne Shumway-Cook (1995) and has been used with older adults to determine their likelihood of falling. Scores of 19 and less are related to falls in older adults. It tests 8 facets of gait and can be used with an assistive device.
CTSIB TEST
Time frame: 10 min
The test is the therapist\'s version of the Computerized Dynamic Post urography which attempts to measure the way that vision, Vestibular and somatosensory interaction allows us to maintain our balance against the forces of gravity. The test was developed by Shumway Cook and Horak in 1986 and further discussed as a clinical tool in 1987 Patients with uncompensated unilateral vestibular deficits have been shown to have difficulty when visual and support surface information are manipulated.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Background: PubMed 15057920Strader DB, Wright T, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C. Hepatology. 2004 Apr;39(4):1147-71. doi: 10.1002/hep.20119. No abstract available.
- 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.
Asra Ghafoor, 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 DYNAMIC CYCLING and INCLINED TREAD MILL in people with Balance Assessment, 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 0 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 5 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad Dr, PhD (9233224390125, Imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic gate index (time frame: 10-15 min). 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 NCT06673836, 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 5 Nov 2024.