Clinical Utility of Olfactory Rehabilitation: Treatment for Pacients With Neurosensorial Anosmia

NCT ID: NCT04957563

Last Updated: 2021-07-12

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-20

Study Completion Date

2014-10-20

Brief Summary

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The aim of our study was to compare the recovery of smell in people suffering posttraumatic olfactory impairment following a systematic olfactory rehabilitation performed by occupational therapists to natural recovery in a control posttraumatic group of patients.

Detailed Description

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Forty participants started the study: 20 for the control group and 20 for the treatment group. The mean of the time span between the traumatic event and the first visit in the rehabilitation group was longer than 22 months, time enough to wait any kind of spontaneous recovery.

In order to establish correct comparisons, the investigators analyzed whether both groups of participants (control group and treatment group) were homogeneous or not regarding the age, gender, time span between the traumatic event and the first visit to the office, brain damage and loss of conscience. Investigators administered visual analogic scale (VAS), CCCRC olfactory test and quality of life questionnaire (RSDI) to both groups at the beginning of the study and 12 months late

Conditions

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Anosmia Occupational Therapy Brain Injuries, Traumatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

control group and experimental group
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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experimental rehabilitation

recived olfactory rehabilitation

Group Type EXPERIMENTAL

olfactory rehabilitation

Intervention Type BEHAVIORAL

treatment for improve olfactory function

control

withouth olfactory rehabilitation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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olfactory rehabilitation

treatment for improve olfactory function

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Olfactory loss participants from institution to the Smell \& Tast Office, Otorhinolaryngology Unit, Hospital Universitario Fundación Alcorcón.

All participants provided written informed consent

Exclusion Criteria

* No sign informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cristina Gomez Calero

OTHER

Sponsor Role lead

Responsible Party

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Cristina Gomez Calero

PhD. Professor. Occupational therapist

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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09/79 (HUFA)

Identifier Type: -

Identifier Source: org_study_id

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