NCT02746770

Brief Summary

Spanish population with unilateral peripheral vestibular disorders.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

February 1, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
Last Updated

April 21, 2016

Status Verified

April 1, 2016

Enrollment Period

2 months

First QC Date

February 25, 2016

Last Update Submit

April 20, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Activities-specific Balance Confidence scale (ABC)

    Activities-specific Balance Confidence scale (ABC), to quantify the level of confidence in performing a specific task without losing balance or becoming unsteady. This scale is applied to assess the change due to intervention between the baseline and 6 weeks of treatment. So the data will be collected at baseline and after 6 weeks of treatment.

    Baseline and after 6 weeks of intervention

Secondary Outcomes (2)

  • UCLA Dizziness Questionnaire (UCLA-DQ)

    Baseline and after 6 weeks of intervention

  • Dizziness Handicap Inventory (DHI),

    Baseline and after 6 weeks of intervention

Study Arms (2)

Cawthorne and Cooksey exercises group

EXPERIMENTAL

Intervention: Participants allocated in both control and experimental groups were receiving treatment for their specific vestibular disorders. Patients assigned to the experimental group also performed the Cawthorne and Cooksey exercises for vestibular rehabilitation during a six week of treatment period.

Other: Experimental: Cawthorne and Cooksey exercises group

control group

NO INTERVENTION

intervention: The control group will not perform the active exercise that will be applied to intervention group.

Interventions

Experimental: intervention group. Patients assigned to the experimental group will perform the Cawthorne and Cooksey exercises for vestibular rehabilitation in addition to their habitual treatment.

Cawthorne and Cooksey exercises group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants with with unilateral peripheral vestibular disorders

You may not qualify if:

  • Bilateral vestibular disorders
  • Fluctuating or active unilateral vestibular disease
  • Or other medical conditions in the acute phase were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Study Design

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

Study Record Dates

First Submitted

February 25, 2016

First Posted

April 21, 2016

Study Start

February 1, 2016

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 21, 2016

Record last verified: 2016-04