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Effects of oculomotor and gaze stability exercises on balance after stroke: Clinical trial protocol.

ABSTRACT: Highlights:Balance problems after stroke are an important risk factor for falling.The inability to maintain balance decreased potential for recovery.This trial assesses the effect of oculomotor and gaze stability training on balance. Background:The inability to maintain balance after stroke is an important risk factor for falling and relates to decreased potential for recovery. The vestibular system and gaze stability contribute respectively to postural stability and to maintain balance. Rehabilitation may be more effective with domiciliary training. Objective:This trial aims to verify if balance impairment after stroke improves with a domiciliary oculomotor and gaze stability training program. Methods:Individuals older than 60 years, discharged after suffering brain stroke with referral to the physiotherapy department, will be assessed for orthostatic balance. Patients with stroke diagnosis 3-15 months before recruitment, positive Romberg test and able to walk 3 m alone are invited to participate in this randomized controlled trial. Participants will be allocated in two intervention groups through block randomization, either the current rehabilitation program or to a supplemental intervention focused on oculomotor and gaze stability exercises to be applied at home twice a day for three weeks. Primary outcome measures are the Motor Assessment Scale, Berg Balance Scale and Timed Up and Go Test. Trial registration: ClinicalTrials.gov (NCT02280980). Results:A minimum difference of four seconds in the TUG and a minimum difference of four points in BBS will be considered positive outcomes. Conclusions:Oculomotor and gaze stability exercises may be a promising complement to conventional physiotherapy intervention after brain stroke, improving the balance impairment.

SUBMITTER: Pimenta C

PROVIDER: S-EPMC6806978 | biostudies-literature | 2017 May-Jun

REPOSITORIES: biostudies-literature

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Effects of oculomotor and gaze stability exercises on balance after stroke: Clinical trial protocol.

Pimenta Carla C Correia Anabela A Alves Marta M Virella Daniel D

Porto biomedical journal 20170212 3

<h4>Highlights</h4>Balance problems after stroke are an important risk factor for falling.The inability to maintain balance decreased potential for recovery.This trial assesses the effect of oculomotor and gaze stability training on balance.<h4>Background</h4>The inability to maintain balance after stroke is an important risk factor for falling and relates to decreased potential for recovery. The vestibular system and gaze stability contribute respectively to postural stability and to maintain b ...[more]

PMID: 32258591

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Project description:BACKGROUND:Digital media and gaming have received considerable interest from researchers and clinicians as a model for learning a broad range of complex tasks and facilitating the transfer of skills to daily life. These emerging rehabilitation technologies have the potential to improve clinical outcomes and patient participation because they are engaging, motivating, and accessible. Our research goal is to develop preventative and therapeutic point-of-care eHealth applications that will lead to equivalent or better long-term health outcomes and health care costs than existing programs. We have produced a novel computer-aided tele-rehabilitation platform that combines computer game-based exercises with tele-monitoring. OBJECTIVE:Compare the therapeutic effectiveness of an in-home, game-based rehabilitation program (GRP) to standard care delivered in an outpatient physical therapy clinic on measures of balance, gaze control, dizziness, and health-related quality of life. METHODS:A randomized, controlled, single-blind pilot trial will be conducted. Fifty-six participants with a diagnosis of peripheral vestibular disorder will be randomly assigned to either usual physical therapy (comparator group) or to a game-based intervention (experimental group). Measures to be assessed will include gaze control, dynamic balance, and self-reported measures of dizziness. RESULTS:The project was funded and enrollment was started in August 2014. To date, 36 participants have been enrolled. There have been 6 drop-outs. It is expected that the study will be completed January 2016 and the first results are expected to be submitted for publication in Spring of 2016. CONCLUSIONS:A successful application of this rehabilitation program would help streamline rehabilitation services, leverage therapist time spent with clients, and permit regular practice times at the client's convenience. TRIAL REGISTRATION:Clinicaltrials.gov: NCT02134444; https://clinicaltrials.gov/ct2/show/NCT02134444 (Archived by WebCite at http://www.webcitation.org/6cE18bqqY).

Project description:BackgroundThe use of vestibular rehabilitation principles in the management of gaze and postural stability impairments in people with multiple sclerosis (PwMS) has shown promise in pilot work completed in our lab and in a recently published randomized clinical trial (RCT). However, further work is needed to fully quantify the gaze and postural impairments present in people with multiple sclerosis and how they respond to rehabilitation.Methods/designThe study is a single blind RCT designed to examine the benefit of a gaze and postural stability (GPS) intervention program compared to a standard of care (SOC) rehabilitation program in dizzy and balance impaired PwMS. Outcomes will be collected across the domains of body structure and function, activity, and participation as classified by the World Health Organization International Classification of Functioning, Disability, and Health (ICF). Our primary outcomes are the Dizziness Handicap Inventory (DHI) and the Functional Gait Assessment (FGA). Secondary outcomes include other measures of gaze and postural stability, fatigue, and functional mobility. Participants who are interested and eligible for enrollment will be consented prior to completing a baseline assessment. Following the baseline assessment each participant will be randomized to either the GPS or SOC intervention group and will complete a 6 week treatment period. During the treatment period, both groups will participate in guided exercise 3x/week. Following the treatment period participants will be asked to return for a post-treatment evaluation and again for a follow-up assessment 1 month later. We anticipate enrolling 50 participants.DiscussionThis study will be an innovative RCT that will utilize gaze and postural stability metrics to assess the efficacy of vestibular rehabilitation in PwMS. It will build on previous work by examining measures across the ICF and improve the current evidence base for treating PwMS.Trial registrationClinicalTrials.gov, May 29th 2018, NCT03521557 .

Project description:IntroductionBloodstream infections are a leading cause of mortality and morbidity; the duration of treatment for these infections is understudied.Methods and analysisWe will conduct an international, multicentre randomised clinical trial of shorter (7 days) versus longer (14 days) antibiotic treatment among hospitalised patients with bloodstream infections. The trial will include 3626 patients across 60 hospitals and 6 countries. We will include patients with blood cultures confirming a pathogenic bacterium after hospital admission. Exclusion criteria will include patient factors (severe immunosuppression), infection site factors (endocarditis, osteomyelitis, undrained abscesses, infected prosthetic material) and pathogen factors (Staphylococcus aureus, Staphylococcus lugdunensis, Candida and contaminant organisms). We will leave the selection of specific antibiotics, doses and route of delivery to the discretion of treating physicians; no placebo control will be used given the diversity of pathogens and sources of bacteraemia. The intervention will be assignment of treatment duration to be 7 versus 14 days. We will minimise selection bias via central randomisation with variable block sizes, with concealed allocation until day 7 of adequate antibiotic treatment. The primary outcome is 90-day survival; we will test whether 7 days is non-inferior to 14 days of treatment, with a non-inferiority margin of 4% absolute mortality. Secondary outcomes include hospital and intensive care unit (ICU) mortality, relapse rates of bacteraemia, hospital and ICU length of stay, mechanical ventilation and vasopressor duration, antibiotic-free days, Clostridium difficile infection, antibiotic allergy and adverse events and colonisation/infection with antibiotic-resistant organisms.Ethics and disseminationThe study has been approved by the ethics review board at each participating site. Sunnybrook Health Sciences Centre is the central ethics committee. We will disseminate study results via the Canadian Critical Care Trials Group and other collaborating networks to set the global paradigm for antibiotic treatment duration for non-staphylococcal Gram-positive, Gram-negative and anaerobic bacteraemia, among patients admitted to hospital.Trial registration numberThe BALANCE (Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness) trial was registered at www.clinicaltrials.gov (registration number: NCT03005145).

Project description:BackgroundProtocols involving intensive practice have shown positive outcomes. Constraint induced movement therapy (CIT) appears to be one of the best options for better outcomes in upper limb rehabilitation, but we still have little data about lower extremity constraint-induced movement therapy (LE-CIT) and its effects on gait and balance.ObjectiveTo evaluate the effects of an LE-CIT protocol on gait functionality and balance in chronic hemiparetic patients following a stroke.MethodsThe study adopts a randomized, controlled, single-blinded study design. Forty-two patients, who suffered a stroke, who were in the chronic phase of recovery (>6 months), with gait disability (no community gait), and who were able to walk at least 10 m with or without the advice or support of 1 person, will be randomly allocated to 2 groups: the LE-CIT group or the control group (intensive conventional therapy). People will be excluded if they have speech deficits that render them unable to understand and/or answer properly to evaluation scales and exercises selected for the protocol and/or if they have suffered any clinical event between the screening and the beginning of the protocol. Outcome will be assessed at baseline (T0), immediately after the intervention (T1), and after 6 months (T2). The outcome measures chosen for this trial are as follows: 6-min walk test (6minWT), 10-m walk test (10mWT), timed up and go (TUG), 3-D gait analysis (3DGA), Mini Balance Evaluation Systems Test (Mini-BESTest), and as a secondary measure, Lower Extremity Motor Activity Log will be evaluated (LE-MAL). The participants in both groups will receive 15 consecutive days of daily exercise. The participants in the LE-CIT group will be submitted to this protocol 2.5 h/day for 15 consecutive days. It will include (1) intensive supervised training, (2) use of shaping as strategy for motor training, and (3) application of a transfer package (plus 30 min). The control group will receive conventional physiotherapy for 2.5 h/day over 15 consecutive days (the same period as the CIT intervention). Repeated measures analyses will be made to compare differences and define clinically relevant changes between groups.ResultsData collection is currently on-going and results are expected in 2021.DiscussionLE-CIT seems to be a good protocol for inclusion into stroke survivors' rehabilitation as it has all the components needed for positive results, as well as intensity and transference of gains to daily life activities.Trial registrationwww.ensaiosclinicos.gov.br RBR-467cv6 . Registered on 10 October 2017. "Effects of Lower Extremities - Constraint Induced Therapy on gait and balance function in chronic hemipretic post-stroke patients".

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Effects of oculomotor and gaze stability exercises on balance after stroke: Clinical trial protocol.

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Effects of oculomotor and gaze stability exercises on balance after stroke: Clinical trial protocol.

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