Effect of Oculomotor and Gaze Stability Exercises on the Improvement of Balance After Stroke (BETTERBALANCE)
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|ClinicalTrials.gov Identifier: NCT02280980|
Recruitment Status : Enrolling by invitation
First Posted : November 3, 2014
Last Update Posted : April 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stroke Distorted; Balance||Other: Oculomotor and Gaze Stability Exercises||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of Oculomotor and Gaze Stability Exercises on the Improvement of Balance After Brain Stroke in Patients Older Than 60 Years Old|
|Actual Study Start Date :||July 2014|
|Estimated Primary Completion Date :||July 15, 2018|
|Estimated Study Completion Date :||February 28, 2019|
Experimental: Combined rehabilitation protocol
The usual rehabilitation protocol in the physiotherapy department is supplemented with a three weeks home protocol of oculomotor and gaze stability exercises.
Other: Oculomotor and Gaze Stability Exercises
Daily oculomotor and gaze stability exercises, twice a day, for three weeks
No Intervention: Usual rehabilitation protocol
The usual rehabilitation protocol in the physiotherapy department for patients after stroke.
- Berg Balance Scale (BBS) [ Time Frame: Change on BBS from baseline up to three weeks of intervention ]Balance measure used in older people with impairment in balance function by assessing the performance of functional tasks
- Timed Up and Go Test (TUG) [ Time Frame: Change on TUG from baseline up to three weeks of intervention ]simple test used to assess mobility and requires both static and dynamic balance
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280980
|Principal Investigator:||Anabela Correia, Pt, MSc||Centro Hospitalar de Lisboa Central|
|Principal Investigator:||Carla Pimenta, Pt, MSc||Centro Hospitalar de Lisboa Central|