- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05118659
Mulligan Therapy Effects In Healthy Subjects With Induced Vertigo
November 3, 2021 updated by: Jose Vicente Leon Hernandez, Centro Universitario La Salle
Mulligan Therapy Effects In Healthy Subjects With Induced Vertigo. A Randomized And Controlled Clinic Study
This analysis aims to evaluate the immediate effect that cervical sustained natural apophyseal glides (SNAGs) have on a group of individuals with induced vertigo by a caloric vestibular stimulation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
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 Locations
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Madrid, Spain, 28023
- CSEU La Salle
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Madrid, Spain, 28023
- Jose V Leon Hernandez
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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
18 years to 44 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy subjects,
- Age 18-44 years.
Exclusion Criteria:
- Consume of antipsychotics, antidepressants, antiarrythmics and/or anticonvulsivants
- Hippoacusia
- Auditory diseases
- Peripheral or central vestibulopathies
- Cerviogenic dizziness
- Balance disorders
- Nistagmus
- Oculomotor nerve dysfunctions
- Migraine
- Cervical osteoporosis, lashing or fracture
- Discal cervical hernia
- Cervical neuropathy
- Psychriatic disorders
- Epilepsy
- Pregnancy
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: SNAG GROUP
The SNAG group received a treatment based on sustained apophyseal glides in a postero-anterior direction on C2 with a dose of three series of ten repetitions each, combined with active cervical extension.
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It consists on a sustained apophyseal glides in a postero-anterior direction on C2 with a dose of three series of ten repetitions each
Other Names:
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Sham Comparator: SHAM SNAG GROUP
The placebo SNAG group received a simulation of the contact used for the SNAGs, without any vertebral glide, and with an active cervical extension.
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Subjects on SNAG group received a simulation of the contact used for the SNAGs, without any vertebral glide, and with an active cervical extension
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No Intervention: CONTROL GROUP
The control group did not receive any type of intervention, they only waited for four minutes, sat down on a chair
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
vHIT (Video Head Impulse Test)
Time Frame: 15 minutes
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Detection of peripheral vestibular deficits and their recovery
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15 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety
Time Frame: 5 minutes
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state-trait anxiety was measured at the beginning of the study using the Spanish version of the trait-state anxiety inventory (STAI)
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5 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
February 3, 2018
Primary Completion (Actual)
June 4, 2018
Study Completion (Actual)
June 28, 2018
Study Registration Dates
First Submitted
October 19, 2021
First Submitted That Met QC Criteria
November 3, 2021
First Posted (Actual)
November 12, 2021
Study Record Updates
Last Update Posted (Actual)
November 12, 2021
Last Update Submitted That Met QC Criteria
November 3, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSEULS-PI-198/2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Data will only be treated by study researchers
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.
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