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

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
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
NCT ID
NCT02280980
First Posted
October 30, 2014
Last Updated
March 24, 2020
Sponsor
Centro Hospitalar de Lisboa Central
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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