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

October 29, 2020 updated by: Roy La Touche Arbizu, Universidad Autonoma de Madrid

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

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

  • Spain
      • Madrid, Spain, 28023
        • CSEU La Salle

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo group
Behavioral: Placebo group
The idea is to show some videos of vegetation with the aim of having an intervention time but ineffective.
Experimental: Action observation group
Behavioral: Action observation
The idea is to show some videos with the aim of improving patients' tongue strength.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change in immediately at the end of the intervention and also, changes between the end and three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cervical Range of motion
Time Frame: Change in immediately at the end of the intervention and also, changes between the end and three months
The cervical goniometer will measure the active cervical range of motion
Change in immediately at the end of the intervention and also, changes between the end and three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autonoma de Madrid

Collaborators

Centro Universitario La Salle

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 (Anticipated)

November 15, 2020

Primary Completion (Anticipated)

July 30, 2021

Study Completion (Anticipated)

September 30, 2021

Study Registration Dates

First Submitted

October 29, 2020

First Submitted That Met QC Criteria

October 29, 2020

First Posted (Actual)

November 4, 2020

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

October 29, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • uammadrid91

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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