Effect of Oculomotor and Gaze Stability Exercises on the Improvement of Balance After Stroke
BETTERBALANCE
Effectiveness of Oculomotor and Gaze Stability Exercises on the Improvement of Balance After Brain Stroke in Patients Older Than 60 Years Old
1 other identifier
interventional
66
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Jul 2014
Longer than P75 for not_applicable stroke
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 30, 2014
CompletedFirst Posted
Study publicly available on registry
November 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2020
CompletedMarch 25, 2020
March 1, 2020
5.5 years
October 30, 2014
March 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Berg Balance Scale (BBS)
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)
simple test used to assess mobility and requires both static and dynamic balance
Change on TUG from baseline up to three weeks of intervention
Study Arms (2)
Combined rehabilitation protocol
EXPERIMENTALThe usual rehabilitation protocol in the physiotherapy department is supplemented with a three weeks home protocol of oculomotor and gaze stability exercises.
Usual rehabilitation protocol
NO INTERVENTIONThe usual rehabilitation protocol in the physiotherapy department for patients after stroke.
Interventions
Daily oculomotor and gaze stability exercises, twice a day, for three weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (9)
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.
BACKGROUNDBerg 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.
PMID: 1468055BACKGROUNDCarr 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.
PMID: 3969398BACKGROUNDDias 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.
BACKGROUNDGeurts 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.
PMID: 16214666BACKGROUNDHiengkaew 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.
PMID: 22502805BACKGROUNDMorimoto 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.
PMID: 21334899BACKGROUNDCorreia 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.
PMID: 32907392DERIVEDPimenta 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.
PMID: 32258591DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anabela Correia, Pt, MSc
Centro Hospitalar de Lisboa Central
- PRINCIPAL INVESTIGATOR
Carla Pimenta, Pt, MSc
Centro Hospitalar de Lisboa Central
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2014
First Posted
November 3, 2014
Study Start
July 1, 2014
Primary Completion
January 15, 2020
Study Completion
March 15, 2020
Last Updated
March 25, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
Patients are informed that their records are available to them.