Movement, InvoluntaryNCT04615598
Assessment of the Effects of Mental Practice on Tongue Strength in Brain-damaged Patients
A study testing Action observation in people with Movement, Involuntary, run by Universidad Autonoma de Madrid at 1 site in Spain.
Trial summary
The main objective is to evaluate the effects of action-observation training on tongue strength in brain-damaged patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Movement, Involuntary
- What is being tested?
- Action observation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 15 Nov 2020to 30 Sep 2021
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70
- Date of injury : 6 months onwards
- Medical diagnosis: brain damage or head trauma
- Clinical diagnosis of dysphagia by videofluoroscopy or V-CAM and expert opinion.
Who cannot join
- Not understanding verbal or auditory/visual commands through the Boston Test
- Present behavioural alterations
- Presence of seizures
- Presence of tracheotomy
- Impulsivity
- Attention Problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of Action Observation Training on Tongue Strength in Brain-damaged Patients: a Non-randomized Controlled Trial
The main objective is to evaluate the effects of action-observation training on tongue strength in brain-damaged patients.
- Conditions
- Movement, Involuntary
- Being tested
- Action observation, Placebo group
- Keywords
- Action observation
- Medical subject headings
- Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action observationBehavioural
The idea is to show some videos with the aim of improving patients' tongue strength.
Placebo groupBehavioural
The idea is to show some videos of vegetation with the aim of having an intervention time but ineffective.
| Study group | Role | What they receive |
|---|---|---|
| Action observation group | Experimental | Not described Receives: Behavioral: Action observation |
| Placebo group | Placebo comparator | Not described Receives: Behavioral: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lingual strength
The IOPI instrument has a mechanical sensor that evaluates the force.
Measured: Change in immediately at the end of the intervention and also, changes between the end and three months
Secondary outcomes (1)
Cervical Range of motion
The cervical goniometer will measure the active cervical range of motion
Measured: Change in immediately at the end of the intervention and also, changes between the end and three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start15 Nov 2020 (estimated)
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Movement, InvoluntaryStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Universitario La Salle
- Responsible party
- Principal investigator, Roy La Touche Arbizu, Universidad Autonoma de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615598
- Sponsor's protocol ID
- uammadrid91
- Status last verified
- Oct 2020
- First submitted
- 29 Oct 2020
- Last updated
- 4 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Action Observation Training on Tongue Strength in Brain-damaged Patients: a Non-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04615598
- Acronym / sponsor ID
- uammadrid91
- Conditions
- Movement, Involuntary
- Keywords
- Action observation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Collaborators
- Centro Universitario La Salle
- Study start
- 15 Nov 2020 (estimated)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 4 Nov 2020 (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.
The main objective is to evaluate the effects of action-observation training on tongue strength in brain-damaged patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Action observation group | Experimental | Behavioral: Action observation |
| Placebo group | Placebo comparator | Behavioral: Placebo group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 70
- Date of injury : 6 months onwards
- Medical diagnosis: brain damage or head trauma
- Clinical diagnosis of dysphagia by videofluoroscopy or V-CAM and expert opinion.
Key exclusion criteria (6 listed)
- Not understanding verbal or auditory/visual commands through the Boston Test
- Present behavioural alterations
- Presence of seizures
- Presence of tracheotomy
- Impulsivity
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 |
|---|---|---|
| Action observationThe idea is to show some videos with the aim of improving patients' tongue strength. | Behavioural | Action observation group |
| Placebo groupThe idea is to show some videos of vegetation with the aim of having an intervention time but ineffective. | Behavioural | Placebo group |
Primary outcome
Lingual strength
Time frame: Change in immediately at the end of the intervention and also, changes between the end and three months
The IOPI instrument has a mechanical sensor that evaluates the force.
1 secondary outcome
Cervical Range of motion
Time frame: Change in immediately at the end of the intervention and also, changes between the end and three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
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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 Action observation in people with Movement, Involuntary, run by Universidad Autonoma de Madrid 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 4 Nov 2020. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Lingual strength (time frame: Change in immediately at the end of the intervention and also, changes between the end and three months). 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 4 Nov 2020.