Vestibular System DisorderNCT06197750
Effect of Vestibular Stimulation on Motor Proficiency and Balance Among Children With Down Syndrome
A study testing Vestibular stimulation and General strengthening exercises in people with Vestibular System Disorder, run by Riphah International University at 1 site in Pakistan.
Trial summary
This was a randomized controlled trial study where there the total participants were 22and these participants were randomly selected and then distributed in to two groups all participants were selected according to the inclusion exclusion criteria of the study and then they were randomly distributed in two groups… Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Vestibular System Disorder
- What is being tested?
- Vestibular stimulation and General strengthening exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2022to 16 Dec 2022
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6 to 11 years
- Having no other medical history (6)
Who cannot join
- • Visual impairment
- Patient with hearing impairment
- Patient with poor cognition (6, 8)
Trial locations and contacts
1 site in 1 country.
About this study
This was a randomized controlled trial study where there the total participants were 22and these participants were randomly selected and then distributed in to two groups all participants were selected according to the inclusion exclusion criteria of the study and then they were randomly distributed in two groups named as group A and group B both of the contain equal number of participants which are randomly distributed in groups each group contain 11 participants .Group A received the vestibular stimulation by swing in different positions supine, prone and with or without support in each position for 10minnts 3 times a week for 10 weeks along with general strengthening exercises of upper and lower limb and group B will receive general strengthening exercises of whole body for same time period. Data will be then analyzed by using SPSS windows version 25
Read the detailed description
This was a randomized controlled trial study where there the total participants were 22and these participants were randomly selected and then distributed in to two groups all participants were selected according to the inclusion exclusion criteria of the study and then they were randomly distributed in two groups named as group A and group B both of the contain equal number of participants which are randomly distributed in groups each group contain 11 participants .Group A received the vestibular stimulation by swing in different positions supine, prone and with or without support in each position for 10minnts 3 times a week for 10 weeks along with general strengthening exercises of upper and lower limb and group B will receive general strengthening exercises of whole body for same time period.
- Conditions
- Vestibular System Disorder
- Being tested
- Vestibular stimulation, General strengthening exercises
- Keywords
- Vestibular stimulation (VeS), Hypotonic cerebral palsy
- Medical subject headings
- Vestibular Diseases, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular stimulationOther
Vestibular stimulation by swing
General strengthening exercisesOther
General strengthening exercises
| Study group | Role | What they receive |
|---|---|---|
| Vestibular stimulation | Experimental | Group A received the vestibular stimulation by swing in different positions supine, prone and with or without support in each position for 10minnts 3 times a week for 10 weeks along with general strengthening exercises of upper and lower limb and Receives: Other: Vestibular stimulation |
| general strengthening exercises | Active comparator | group B will receive general strengthening exercises of whole body for same time period. Receives: Other: General strengthening exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
Improvement in balance from baseline among children with Down syndrome
Measured: 16 WEEKS
motor proficiency
Improvement in motor proficiency from baseline among children with Down syndrome
Measured: 16 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start1 Jun 2022
- Primary completion16 Nov 2022
- Study completion16 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular System DisorderStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fareeha Kausar, PP-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197750
- Sponsor's protocol ID
- REC/RCR&AHS/22/0745
- Status last verified
- Dec 2023
- First submitted
- 5 Feb 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vestibular Stimulation on Motor Proficiency and Balance Among Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT06197750
- Acronym / sponsor ID
- REC/RCR&AHS/22/0745
- Conditions
- Vestibular System Disorder
- Keywords
- Vestibular stimulation (VeS), Hypotonic cerebral palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 16 Nov 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 9 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.
This was a randomized controlled trial study where there the total participants were 22and these participants were randomly selected and then distributed in to two groups all participants were selected according to the inclusion exclusion criteria of the study and then they were randomly distributed in two groups named as group A and group B both of the contain equal number of participants which are randomly distributed in groups each group contain 11 participants .Group A received the vestibular stimulation by swing in different positions supine, prone and with or without support in each position for 10minnts 3 times a week for 10 weeks along with general strengthening exercises of upper and lower limb and group B will receive general strengthening exercises of whole body for same time period. Data will be then analyzed by using SPSS windows version 25
Detailed description
This was a randomized controlled trial study where there the total participants were 22and these participants were randomly selected and then distributed in to two groups all participants were selected according to the inclusion exclusion criteria of the study and then they were randomly distributed in two groups named as group A and group B both of the contain equal number of participants which are randomly distributed in groups each group contain 11 participants .Group A received the vestibular stimulation by swing in different positions supine, prone and with or without support in each position for 10minnts 3 times a week for 10 weeks along with general strengthening exercises of upper and lower limb and group B will receive general strengthening exercises of whole body for same time period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vestibular stimulation | Experimental | Other: Vestibular stimulationGroup A received the vestibular stimulation by swing in different positions supine, prone and with or without support in each position for 10minnts 3 times a week for 10 weeks along with general strengthening exercises of upper and lower limb and |
| general strengthening exercises | Active comparator | Other: General strengthening exercisesgroup B will receive general strengthening exercises of whole body for same time period. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 6 to 11 years
- Having no other medical history (6)
Key exclusion criteria (3 listed)
- • Visual impairment
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 |
|---|---|---|
| Vestibular stimulationVestibular stimulation by swing | Other | Vestibular stimulation |
| General strengthening exercisesGeneral strengthening exercises | Other | general strengthening exercises |
Primary outcome
Berg Balance Scale
Time frame: 16 WEEKS
Improvement in balance from baseline among children with Down syndrome
motor proficiency
Time frame: 16 WEEKS
Improvement in motor proficiency from baseline among children with Down syndrome
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 9 Jan 2024.
- 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.
Fareeha Kausar, PP-DPT 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 Vestibular stimulation and General strengthening exercises in people with Vestibular System Disorder, 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 2 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 9 Jan 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?
Berg Balance Scale (time frame: 16 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?
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 9 Jan 2024.