Assessment of the Effects of Mental Practice on Tongue Strength in Brain-damaged Patients
Primary Purpose
Movement, Involuntary
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Action observation
Placebo group
Sponsored by
About this trial
This is an interventional treatment trial for Movement, Involuntary focused on measuring Action observation
Eligibility Criteria
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
Sites / Locations
- CSEU La Salle
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Action observation group
Placebo group
Arm Description
Outcomes
Primary Outcome Measures
Lingual strength
The IOPI instrument has a mechanical sensor that evaluates the force.
Secondary Outcome Measures
Cervical Range of motion
The cervical goniometer will measure the active cervical range of motion
Full Information
NCT ID
NCT04615598
First Posted
October 29, 2020
Last Updated
October 29, 2020
Sponsor
Universidad Autonoma de Madrid
Collaborators
Centro Universitario La Salle
1. Study Identification
Unique Protocol Identification Number
NCT04615598
Brief Title
Assessment of the Effects of Mental Practice on Tongue Strength in Brain-damaged Patients
Official Title
Evaluation of the Effects of Action Observation Training on Tongue Strength in Brain-damaged Patients: a Non-randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2020 (Anticipated)
Primary Completion Date
July 30, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma de Madrid
Collaborators
Centro Universitario La Salle
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The main objective is to evaluate the effects of action-observation training on tongue strength in brain-damaged patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Movement, Involuntary
Keywords
Action observation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Action observation group
Arm Type
Experimental
Arm Title
Placebo group
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Action observation
Intervention Description
The idea is to show some videos with the aim of improving patients' tongue strength.
Intervention Type
Behavioral
Intervention Name(s)
Placebo group
Intervention Description
The idea is to show some videos of vegetation with the aim of having an intervention time but ineffective.
Primary Outcome Measure Information:
Title
Lingual strength
Description
The IOPI instrument has a mechanical sensor that evaluates the force.
Time Frame
Change in immediately at the end of the intervention and also, changes between the end and three months
Secondary Outcome Measure Information:
Title
Cervical Range of motion
Description
The cervical goniometer will measure the active cervical range of motion
Time Frame
Change in immediately at the end of the intervention and also, changes between the end and three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CSEU La Salle
City
Madrid
ZIP/Postal Code
28023
Country
Spain
12. IPD Sharing Statement
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Assessment of the Effects of Mental Practice on Tongue Strength in Brain-damaged Patients
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