- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04725279
Usefulness of Rehabilitation in Patients With Cervical Imbalance
January 24, 2021 updated by: Marco Polo Royo, Universidad de Zaragoza
Usefulness of Rehabilitation in Patients With Cervical Imbalance. Use of Stabilometric Platform and Motion Sensors. (Provisional Title)
Using the data obtained in a study carried out at the Hospital of Alcañiz (Teruel, Spain) between February and July 2019, with a stabilometric platform and with movement sensors, the investigators want to demonstrate that the rehabilitation works in those patients with vertigo or dizziness of cervical origin.
For this, the data obtained from that sample, which was of 67 patients, will be analyzed in a pre-post rehabilitation treatment study, objectifying whether the patients improved or not, both in terms of imbalance and cervical pain, if any.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Using the data obtained in a study carried out at the Hospital of Alcañiz (Teruel, Spain) between February and July 2019, with a stabilometric platform and with movement sensors, the investigators want to demonstrate that the rehabilitation works in those patients with vertigo or dizziness of cervical origin.
For this, the data obtained from that sample, which was of 67 patients, will be analyzed in a pre-post rehabilitation treatment study, objectifying whether the patients improved or not, both in terms of imbalance and cervical pain, if any.
The 67 patients attended the rehabilitation consultation where, after taking the anamnesis, they began to perform balance tests with a stabilometric platform and those patients with associated neck pain, with cervical motion sensors.
Treatment with conventional physiotherapy, electrotherapy or exercises at home was prescribed as appropriate to each one.
3 months later, the patients were examined again in consultation, using a new anamnesis, the platform and the sensors.
With the data obtained in said field work, carried out in 2019, the present study aims to analyze the usefulness of rehabilitation treatment in vertigo.
Study Type
Interventional
Enrollment (Actual)
67
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
-
-
-
Zaragoza, Spain, 50009
- Facultad de Ciencias de la Salud
-
-
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
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Present vertigo of vestibular, neurological or cervical cause.
- The last episode of vertigo occurred less than a year ago.
Exclusion Criteria:
- Present acute musculoskeletal pathology in the lower limbs or lumbar spine.
- Present some lower limb amputation.
- Present unresolved visual pathology.
- Being active with anticancer treatment.
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: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Type of rehabilitation treatment
Depending on whether the cervical pain associated with vertigo in the patients associated pain radiating to the arms or not, treatment with conventional physiotherapy or electrotherapy was prescribed.
In addition, both groups had a control group that performed exercises at home prescribed by a physician.
|
The 67 patients attended the rehabilitation consultation where, after taking the anamnesis, they began to perform balance tests with a stabilometric platform and those patients with associated neck pain, with cervical motion sensors.
Treatment with conventional physiotherapy, electrotherapy or exercises at home was prescribed as appropriate to each one.
3 months later, the patients were examined again in consultation, using a new anamnesis, the platform and the sensors.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients who improve, worsen or do not present changes after rehabilitation treatment
Time Frame: 3 months passed between the first evaluation and the second.
|
It is evaluated whether the patients, after undergoing the corresponding prescribed rehabilitation treatment, are better, worse or the same as before undergoing it.
|
3 months passed between the first evaluation and the second.
|
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 1, 2019
Primary Completion (Actual)
July 31, 2019
Study Completion (Actual)
July 31, 2019
Study Registration Dates
First Submitted
January 17, 2021
First Submitted That Met QC Criteria
January 24, 2021
First Posted (Actual)
January 26, 2021
Study Record Updates
Last Update Posted (Actual)
January 26, 2021
Last Update Submitted That Met QC Criteria
January 24, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MPolo
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Data from the 67 patients who were part of the study will not be shared with anyone who did not participate in the study.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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