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

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ClinicalTrials.gov Identifier: NCT02280980
Recruitment Status : Enrolling by invitation
First Posted : November 3, 2014
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Centro Hospitalar de Lisboa Central

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stroke Distorted; Balance Other: Oculomotor and Gaze Stability Exercises Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Oculomotor and Gaze Stability Exercises on the Improvement of Balance After Brain Stroke in Patients Older Than 60 Years Old
Actual Study Start Date : July 2014
Estimated Primary Completion Date : July 15, 2018
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280980


Sponsors and Collaborators
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:
Responsible Party: Centro Hospitalar de Lisboa Central
ClinicalTrials.gov Identifier: NCT02280980     History of Changes
Other Study ID Numbers: CHLC.CI.HCC7.2014
First Posted: November 3, 2014    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patients are informed that their records are available to them.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)

Keywords provided by Centro Hospitalar de Lisboa Central:
Stroke
Postural Balance
Oculomotor and Gaze Stability Exercises
Rehabilitation
Physical therapy
Outpatient

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases