MedDataX Logo

Assessment of the Effects of Mental Practice on Tongue Strength in Brain-damaged Patients

NCT ID: NCT04615598

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-15

Study Completion Date

2021-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The main objective is to evaluate the effects of action-observation training on tongue strength in brain-damaged patients.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Movement, Involuntary

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Action observation group

Group Type EXPERIMENTAL

Action observation

Intervention Type BEHAVIORAL

The idea is to show some videos with the aim of improving patients' tongue strength.

Placebo group

Group Type PLACEBO_COMPARATOR

Placebo group

Intervention Type BEHAVIORAL

The idea is to show some videos of vegetation with the aim of having an intervention time but ineffective.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Action observation

The idea is to show some videos with the aim of improving patients' tongue strength.

Intervention Type BEHAVIORAL

Placebo group

The idea is to show some videos of vegetation with the aim of having an intervention time but ineffective.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* Not understanding verbal or auditory/visual commands through the Boston Test
* Present behavioural alterations
* Presence of seizures
* Presence of tracheotomy
* Impulsivity
* Attention Problems
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centro Universitario La Salle

OTHER

Sponsor Role collaborator

Universidad Autonoma de Madrid

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Roy La Touche Arbizu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CSEU La Salle

Madrid, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

uammadrid91

Identifier Type: -

Identifier Source: org_study_id