NCT04615598

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 4, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

November 15, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

November 4, 2020

Status Verified

October 1, 2020

Enrollment Period

9 months

First QC Date

October 29, 2020

Last Update Submit

October 29, 2020

Conditions

Movement, Involuntary

Keywords

Action observation

Outcome Measures

Primary Outcomes (1)

  • Lingual strength

    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 Outcomes (1)

  • Cervical Range of motion

    Change in immediately at the end of the intervention and also, changes between the end and three months

Study Arms (2)

Action observation group

EXPERIMENTAL
Behavioral: Action observation

Placebo group

PLACEBO COMPARATOR
Behavioral: Placebo group

Interventions

Action observationBEHAVIORAL

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

Action observation group
Placebo groupBEHAVIORAL

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

Placebo group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CSEU La Salle

Madrid, 28023, Spain

Location

MeSH Terms

Conditions

Dyskinesias

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 29, 2020

First Posted

November 4, 2020

Study Start

November 15, 2020

Primary Completion

July 30, 2021

Study Completion

September 30, 2021

Last Updated

November 4, 2020

Record last verified: 2020-10

Locations

ES(1)