Effect of Oculomotor and Gaze Stability Exercises on the Improvement of Balance After Stroke (BETTERBALANCE)

March 24, 2020 updated by: Centro Hospitalar de Lisboa Central

Effectiveness of Oculomotor and Gaze Stability Exercises on the Improvement of Balance After Brain Stroke in Patients Older Than 60 Years Old

Individuals older than 60 years old, discharged after suffering brain stroke with referral to the rehabilitation outpatient clinic, will be assessed for orthostatic balance. Patients with positive Romberg test are invited to participate in the trial. Participants will be randomized to either the current rehabilitation protocol or to an supplemental intervention focused on oculomotor and gaze stability exercises to be applied at home for three weeks. Participants will be assessed with standardized, validated tools.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study aims to evaluated the effect of a home program of oculomotor and gaze stability exercises on improvement the balance in stroke patients.

Individuals older than 60 years old, discharged after suffering brain stroke and referred to the neurologic rehabilitation outpatient clinic, will be assessed for a neuro-motor deficits. Patients will be consider eligible if they had positive Romberg test (disorder of orthostatic balance) and they will be invited to participate in the trial. Patients with previous balance problems will be excluded.

Participants will be allocated in two intervention groups through block randomization, either the current rehabilitation protocol or to an supplemental intervention focused on oculomotor and gaze stability exercises to be applied at home for three weeks. Participants will be assessed with Motor Assessment Scale, Berg Balance Scale and Timed Up and Go Test.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

58 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stroke diagnosis 3 to 15 months before recruitment
  • Balance deficits (positive Romberg)
  • Patients able to walk 3 meters without assistance with or without an assistive device

Exclusion Criteria:

  • Balance problems previous to the index stroke
  • Severe osteo-articular lesions that compromise the ability to perform the proposed exercises
  • Previous exposure to oculomotor or gaze stability exercises

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combined rehabilitation protocol
The usual rehabilitation protocol in the physiotherapy department is supplemented with a three weeks home protocol of oculomotor and gaze stability exercises.
Other: Oculomotor and Gaze Stability Exercises
Daily oculomotor and gaze stability exercises, twice a day, for three weeks
No Intervention: Usual rehabilitation protocol
The usual rehabilitation protocol in the physiotherapy department for patients after stroke.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Berg Balance Scale (BBS)
Time Frame: Change on BBS from baseline up to three weeks of intervention
Balance measure used in older people with impairment in balance function by assessing the performance of functional tasks
Change on BBS from baseline up to three weeks of intervention
Timed Up and Go Test (TUG)
Time Frame: Change on TUG from baseline up to three weeks of intervention
simple test used to assess mobility and requires both static and dynamic balance
Change on TUG from baseline up to three weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Hospitalar de Lisboa Central

Investigators

  • Principal Investigator: Anabela Correia, Pt, MSc, Centro Hospitalar de Lisboa Central
  • Principal Investigator: Carla Pimenta, Pt, MSc, Centro Hospitalar de Lisboa Central

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Actual)

January 15, 2020

Study Completion (Actual)

March 15, 2020

Study Registration Dates

First Submitted

October 30, 2014

First Submitted That Met QC Criteria

October 30, 2014

First Posted (Estimate)

November 2, 2014

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHLC.CI.HCC7.2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Patients are informed that their records are available to them.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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