Clinical trial NCT02280980: Effect of Oculomotor and Gaze Stability Exercises on the Improvement of Balance After Stroke
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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Distorted; Balance
Keywords: Stroke
Postural Balance
Oculomotor and Gaze Stability Exercises
Rehabilitation
Physical therapy
Outpatient
Lead sponsor: Centro Hospitalar de Lisboa Central
Sponsor class: OTHER
First posted: 2014-11-02
Enrollment: 66
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Berg Balance Scale (BBS)
timeFrame: Change on BBS from baseline up to three weeks of intervention
measure: Timed Up and Go Test (TUG)
timeFrame: Change on TUG from baseline up to three weeks of intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centro Hospitalar de Lisboa Central
name: Anabela Correia, Pt, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Hospitalar de Lisboa Central
name: Carla Pimenta, Pt, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.