Optokinetic Stimulation for Hemineglect
Application of Optokinetic Stimulation in the Treatment of Hemineglect
1 other identifier
interventional
102
1 country
1
Brief Summary
Hemineglect is a sequel to stroke, which appears more frequently when the injury occurs in the right cerebral hemisphere. Hemineglect refers to those patients who do not pay attention to their left side, presenting movement disorders that do not allow them to participate spontaneously in their activities of daily life. There are different methodologies for the treatment of hemineglect. Among them, we find optokinetic stimulation (OKS), which consists of creating an illusory movement to the left to center the patient's frame of reference and thus, make them pay more attention to their left side. In recent years, the effect that this therapy has on motor movement disorders has begun to be explored, although the parameters for its correct application still seem to be unclear. For this reason, our aim is to describe the effect that the OKS has on balance, posture, spatial representation and conscience, and movement disorders in hemineglect. Patients with hemineglect will undergo OKS to see its influence on the recovery of this sequel of stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2023
1 active site
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
First Submitted
Initial submission to the registry
December 4, 2020
CompletedFirst Posted
Study publicly available on registry
December 11, 2020
CompletedStudy Start
First participant enrolled
January 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2023
CompletedJuly 12, 2023
July 1, 2023
12 months
December 4, 2020
July 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Posture
To analyze static posture, a pressure platform will be used. It will be measured before and after the application of each experimental situation
60 minutes
Stability
To analyze static balance, a Carbon 5 Flex® pressure platform will be used. It will be measured before and after the application of each experimental situation
60 minutes
Fluff Test
It is a tool specifically designed to assess body representation in patients with hemineglect, through a body examination with closed eyes, and the removal of stickers located on both sides of the body. The percentage of stickers removed from each part of the body is assessed. It will be measured before and after the application of each experimental situation
60 minutes
Bisection of the line
It is one of the most used tools in the assessment of hemineglect. It consists of marking the middle of a line and evaluating how much deviation to the right occurs. The distance in centimeters to the center of the line is calculated. It will be measured before and after the application of each experimental situation
60 minutes
Fugl Meyer Assessment Scale
This scale assess upper limb, lower limb, balance, sensibility, range of motion and pain in patients with stroke.
60 minutes
Fullerton Advance Balance Test
This scale assess balance and postural control. It has a total punctuation of 40 points. People who are under 25 points have risk of fall.
60 minutes
Diller's cancelation test
This scale assess USN by crossing letters H included with distractors. The number of letters crossed are calculated.
60 minutes
Secondary Outcomes (6)
Sex
1 minute
Date of birth
1 minute
Date of injury
1 minute
Type of injury
1 minute
Admission time
1 minute
- +1 more secondary outcomes
Study Arms (2)
Intervention Group
EXPERIMENTALControl Group
PLACEBO COMPARATORInterventions
Participants are placed in a standing position, with support products, if necessary, and virtual reality glasses will be placed where the visual stimuli will be projected. The study will be carried out for 10 weeks with a frequency of two weekly sessions. During them, the participants will receive stimulation with OKS. Stimulation will be performed at 1 cm/second, the vertical black bars will move to the left. The bars change color and the participants will be asked to detect the changes that will occur in the stimulus.
Participants are placed in a standing position, with support products, if necessary, and virtual reality glasses will be placed where the visual stimuli will be projected. In this group, stimulation consists of a video with static vertical bars that change their colour at a randon intervals, in the same way that in the intervention group. The difference between groups is that in control group, bars are not in movement, preventing from generating optokinetic stimulation.
Eligibility Criteria
You may qualify if:
- year old or older
- Diagnosis of right stroke
- Diagnosis of left heminegligence
You may not qualify if:
- No cooperation and comunication problems
- Uncontrolled epileptic seizures or migraines
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidad de Salamanca
Salamanca, 37007, Spain
Related Publications (1)
Perez-Robledo F, Sanchez Gonzalez JL, Bermejo-Gil BM, Llamas-Ramos R, Martin-Nogueras AM. Optokinetic stimulation effects in the management of unilateral spatial neglect in patients with chronic stroke: study protocol for a randomised controlled trial. BMJ Open. 2023 Jul 30;13(7):e070601. doi: 10.1136/bmjopen-2022-070601.
PMID: 37518082DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Participants will be assigned to one of the groups through a number contained in an opaque envelope. Only the physiotherapist in charge of applying the intervention sessions will know the assignment group of each participant.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
December 4, 2020
First Posted
December 11, 2020
Study Start
January 10, 2023
Primary Completion
December 28, 2023
Study Completion
December 28, 2023
Last Updated
July 12, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- The anonymized database (CSR) will be available from the publication of the results for 10 years in the repository of the University of Salamanca GREDOS. The study protocol, the SAP and the ICF will be published in advance.