NCT04957563

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2009

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2014

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
Last Updated

July 12, 2021

Status Verified

June 1, 2021

Enrollment Period

5 years

First QC Date

June 9, 2021

Last Update Submit

June 30, 2021

Conditions

AnosmiaOccupational TherapyBrain Injuries, Traumatic

Keywords

occupational therapyanosmiabrain injuries, traumatic

Outcome Measures

Primary Outcomes (1)

  • CCCRC

    the Connecticut Chemosensorial Clinical Research Centre test (CCCRC) Cain, W.S., Goodspeed, R.B., Gent, J.F. \& Leonard, G. (1988). Evaluation of olfactory dysfunction in the Connecticut Clinical Chemosensory Research Centre. Laryngoscope, 98:83-8. https://doi.org/10.1288/00005537-198801000-00017

    6 months

Secondary Outcomes (1)

  • RSDI

    6 months

Study Arms (2)

experimental rehabilitation

EXPERIMENTAL

recived olfactory rehabilitation

Behavioral: olfactory rehabilitation

control

NO INTERVENTION

withouth olfactory rehabilitation

Interventions

olfactory rehabilitationBEHAVIORAL

treatment for improve olfactory function

experimental rehabilitation

Eligibility Criteria

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

You may qualify if:

  • Olfactory loss participants from institution to the Smell \& Tast Office, Otorhinolaryngology Unit, Hospital Universitario Fundación Alcorcón.
  • All participants provided written informed consent

You may not qualify if:

  • No sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, Spain

Location

MeSH Terms

Conditions

AnosmiaBrain Injuries, Traumatic

Interventions

Olfactory Training

Condition Hierarchy (Ancestors)

Olfaction DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain InjuriesBrain DiseasesCentral Nervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: control group and experimental group
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD. Professor. Occupational therapist

Study Record Dates

First Submitted

June 9, 2021

First Posted

July 12, 2021

Study Start

October 20, 2009

Primary Completion

October 20, 2014

Study Completion

October 20, 2014

Last Updated

July 12, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)