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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02280980
Other study ID # CHLC.CI.HCC7.2014
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2014
Est. completion date March 15, 2020

Study information

Verified date March 2020
Source Centro Hospitalar de Lisboa Central
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date March 15, 2020
Est. primary completion date January 15, 2020
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Oculomotor and Gaze Stability Exercises
Daily oculomotor and gaze stability exercises, twice a day, for three weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Centro Hospitalar de Lisboa Central

References & Publications (7)

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. — View 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.

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. — View 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.

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. Epub 2004 Dec 7. Review. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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