RehabilitationNCT04725279
Usefulness of Rehabilitation in Patients With Cervical Imbalance
A study testing Rehabilitation Treatment: Physiotherapy, Electrotherapy or Exercises at home in people with Rehabilitation and Cervical Vertigo, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Rehabilitation, Cervical Vertigo
- What is being tested?
- Rehabilitation Treatment: Physiotherapy, Electrotherapy or Exercises at home
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2019to 31 Jul 2019
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Present vertigo of vestibular, neurological or cervical cause.
- The last episode of vertigo occurred less than a year ago.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Rehabilitation, Cervical Vertigo
- Being tested
- Rehabilitation Treatment: Physiotherapy, Electrotherapy or Exercises at home
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation Treatment: Physiotherapy, Electrotherapy or Exercises at homeProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Type of rehabilitation treatment | Experimental | 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. Receives: Procedure: Rehabilitation Treatment: Physiotherapy, Electrotherapy or Exercises at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who improve, worsen or do not present changes after rehabilitation treatment
It is evaluated whether the patients, after undergoing the corresponding prescribed rehabilitation treatment, are better, worse or the same as before undergoing it.
Measured: 3 months passed between the first evaluation and the second.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start1 Feb 2019
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Polo Royo, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725279
- Sponsor's protocol ID
- MPolo
- Status last verified
- Jan 2021
- First submitted
- 17 Jan 2021
- Last updated
- 26 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data from the 67 patients who were part of the study will not be shared with anyone who did not participate in the study.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Rehabilitation in Patients With Cervical Imbalance. Use of Stabilometric Platform and Motion Sensors. (Provisional Title)
- ClinicalTrials.gov ID
- NCT04725279
- Acronym / sponsor ID
- MPolo
- Conditions
- Rehabilitation, Cervical Vertigo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 26 Jan 2021 (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.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type of rehabilitation treatment | Experimental | Procedure: Rehabilitation Treatment: Physiotherapy, Electrotherapy or Exercises at homeDepending 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Present vertigo of vestibular, neurological or cervical cause.
- The last episode of vertigo occurred less than a year ago.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Rehabilitation Treatment: Physiotherapy, Electrotherapy or Exercises at homeThe 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. | Procedure or surgery | Type of rehabilitation treatment |
Primary outcome
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.
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 26 Jan 2021.
- Individual participant dataSharing planned: No. Data from the 67 patients who were part of the study will not be shared with anyone who did not participate in the study.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation Treatment: Physiotherapy, Electrotherapy or Exercises at home in people with Rehabilitation and Cervical Vertigo, run by Universidad de Zaragoza at 1 site in Spain.
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 4 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 26 Jan 2021. 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 Spain. 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?
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 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 26 Jan 2021.