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

Primary Purpose

Stroke, Distorted; Balance

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oculomotor and Gaze Stability Exercises
Sponsored by
Centro Hospitalar de Lisboa Central
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Postural Balance, Oculomotor and Gaze Stability Exercises, Rehabilitation, Physical therapy, Outpatient

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Combined rehabilitation protocol

    Usual rehabilitation protocol

    Arm Description

    The usual rehabilitation protocol in the physiotherapy department is supplemented with a three weeks home protocol of oculomotor and gaze stability exercises.

    The usual rehabilitation protocol in the physiotherapy department for patients after stroke.

    Outcomes

    Primary Outcome Measures

    Berg Balance Scale (BBS)
    Balance measure used in older people with impairment in balance function by assessing the performance of functional tasks
    Timed Up and Go Test (TUG)
    simple test used to assess mobility and requires both static and dynamic balance

    Secondary Outcome Measures

    Full Information

    First Posted
    October 30, 2014
    Last Updated
    March 24, 2020
    Sponsor
    Centro Hospitalar de Lisboa Central
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02280980
    Brief Title
    Effect of Oculomotor and Gaze Stability Exercises on the Improvement of Balance After Stroke
    Acronym
    BETTERBALANCE
    Official Title
    Effectiveness of Oculomotor and Gaze Stability Exercises on the Improvement of Balance After Brain Stroke in Patients Older Than 60 Years Old
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2014 (Actual)
    Primary Completion Date
    January 15, 2020 (Actual)
    Study Completion Date
    March 15, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centro Hospitalar de Lisboa Central

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Distorted; Balance
    Keywords
    Stroke, Postural Balance, Oculomotor and Gaze Stability Exercises, Rehabilitation, Physical therapy, Outpatient

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    66 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Combined rehabilitation protocol
    Arm Type
    Experimental
    Arm Description
    The usual rehabilitation protocol in the physiotherapy department is supplemented with a three weeks home protocol of oculomotor and gaze stability exercises.
    Arm Title
    Usual rehabilitation protocol
    Arm Type
    No Intervention
    Arm Description
    The usual rehabilitation protocol in the physiotherapy department for patients after stroke.
    Intervention Type
    Other
    Intervention Name(s)
    Oculomotor and Gaze Stability Exercises
    Intervention Description
    Daily oculomotor and gaze stability exercises, twice a day, for three weeks
    Primary Outcome Measure Information:
    Title
    Berg Balance Scale (BBS)
    Description
    Balance measure used in older people with impairment in balance function by assessing the performance of functional tasks
    Time Frame
    Change on BBS from baseline up to three weeks of intervention
    Title
    Timed Up and Go Test (TUG)
    Description
    simple test used to assess mobility and requires both static and dynamic balance
    Time Frame
    Change on TUG from baseline up to three weeks of intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anabela Correia, Pt, MSc
    Organizational Affiliation
    Centro Hospitalar de Lisboa Central
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Carla Pimenta, Pt, MSc
    Organizational Affiliation
    Centro Hospitalar de Lisboa Central
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Patients are informed that their records are available to them.
    Citations:
    Citation
    Berg, K., Wood-Dauphinée, S., Williams, J. & Gayton, D. (1989). Measuring balance in the elderly: preliminary development of an instrument. Physiotherapy Canada, 41, 304-311.
    Results Reference
    background
    PubMed Identifier
    1468055
    Citation
    Berg KO, Wood-Dauphinee SL, Williams JI, Maki B. Measuring balance in the elderly: validation of an instrument. Can J Public Health. 1992 Jul-Aug;83 Suppl 2:S7-11.
    Results Reference
    background
    PubMed Identifier
    3969398
    Citation
    Carr JH, Shepherd RB, Nordholm L, Lynne D. Investigation of a new motor assessment scale for stroke patients. Phys Ther. 1985 Feb;65(2):175-80. doi: 10.1093/ptj/65.2.175.
    Results Reference
    background
    Citation
    Dias et al (2009). Aplicação da Escala de Equilíbrio de Berg para verificação do equilíbrio de idosos em diferentes fases do envelhecimento. RBCEH, 6(2), 213-224.
    Results Reference
    background
    PubMed Identifier
    16214666
    Citation
    Geurts AC, de Haart M, van Nes IJ, Duysens J. A review of standing balance recovery from stroke. Gait Posture. 2005 Nov;22(3):267-81. doi: 10.1016/j.gaitpost.2004.10.002. Epub 2004 Dec 7.
    Results Reference
    background
    PubMed Identifier
    22502805
    Citation
    Hiengkaew V, Jitaree K, Chaiyawat P. Minimal detectable changes of the Berg Balance Scale, Fugl-Meyer Assessment Scale, Timed "Up & Go" Test, gait speeds, and 2-minute walk test in individuals with chronic stroke with different degrees of ankle plantarflexor tone. Arch Phys Med Rehabil. 2012 Jul;93(7):1201-8. doi: 10.1016/j.apmr.2012.01.014. Epub 2012 Apr 12.
    Results Reference
    background
    PubMed Identifier
    21334899
    Citation
    Morimoto H, Asai Y, Johnson EG, Lohman EB, Khoo K, Mizutani Y, Mizutani T. Effect of oculo-motor and gaze stability exercises on postural stability and dynamic visual acuity in healthy young adults. Gait Posture. 2011 Apr;33(4):600-3. doi: 10.1016/j.gaitpost.2011.01.016. Epub 2011 Feb 19.
    Results Reference
    background
    PubMed Identifier
    32907392
    Citation
    Correia A, Pimenta C, Alves M, Virella D. Better balance: a randomised controlled trial of oculomotor and gaze stability exercises to reduce risk of falling after stroke. Clin Rehabil. 2021 Feb;35(2):213-221. doi: 10.1177/0269215520956338. Epub 2020 Sep 9.
    Results Reference
    derived
    PubMed Identifier
    32258591
    Citation
    Pimenta C, Correia A, Alves M, Virella D. Effects of oculomotor and gaze stability exercises on balance after stroke: Clinical trial protocol. Porto Biomed J. 2017 May-Jun;2(3):76-80. doi: 10.1016/j.pbj.2017.01.003. Epub 2017 Feb 12.
    Results Reference
    derived

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

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