Optokinetic Stimulation for Hemineglect
Primary Purpose
Perceptual Disorders, Unilateral Spatial Neglect
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Optokinetic stimulation
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Perceptual Disorders focused on measuring Perceptual Disorders, Unilateral spatial neglect, Optokinetic stimulation, Photic stimulation
Eligibility Criteria
Inclusion Criteria:
- 18 year old or older
- Diagnosis of right stroke
- Diagnosis of left heminegligence
Exclusion Criteria:
- No cooperation and comunication problems
- Uncontrolled epileptic seizures or migraines
Sites / Locations
- Universidad de SalamancaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention Group
Control Group
Arm Description
Outcomes
Primary Outcome Measures
Posture
To analyze static posture, a pressure platform will be used. It will be measured before and after the application of each experimental situation
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
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
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
Fugl Meyer Assessment Scale
This scale assess upper limb, lower limb, balance, sensibility, range of motion and pain in patients with stroke.
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.
Diller's cancelation test
This scale assess USN by crossing letters H included with distractors. The number of letters crossed are calculated.
Secondary Outcome Measures
Sex
The sex of the participants is recorded at the start of the study
Date of birth
The participant's date of birth is collected in order to calculate his age in years
Date of injury
The date of the injury is registered in order to calculate the time of evolution with the disease
Type of injury
Description of injury to analyse if it has some effect during intervention
Admission time
Date of involvement in study
National Institutes of Health Stroke Scale
is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
Full Information
NCT ID
NCT04663646
First Posted
December 4, 2020
Last Updated
July 10, 2023
Sponsor
University of Salamanca
1. Study Identification
Unique Protocol Identification Number
NCT04663646
Brief Title
Optokinetic Stimulation for Hemineglect
Official Title
Application of Optokinetic Stimulation in the Treatment of Hemineglect
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
December 28, 2023 (Anticipated)
Study Completion Date
December 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salamanca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perceptual Disorders, Unilateral Spatial Neglect
Keywords
Perceptual Disorders, Unilateral spatial neglect, Optokinetic stimulation, Photic stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial in which an intervention group will undergo optokinetic stimulation with virtual reality glasses, and the control group will receive placebo sessions.
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
102 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Optokinetic stimulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Posture
Description
To analyze static posture, a pressure platform will be used. It will be measured before and after the application of each experimental situation
Time Frame
60 minutes
Title
Stability
Description
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
Time Frame
60 minutes
Title
Fluff Test
Description
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
Time Frame
60 minutes
Title
Bisection of the line
Description
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
Time Frame
60 minutes
Title
Fugl Meyer Assessment Scale
Description
This scale assess upper limb, lower limb, balance, sensibility, range of motion and pain in patients with stroke.
Time Frame
60 minutes
Title
Fullerton Advance Balance Test
Description
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.
Time Frame
60 minutes
Title
Diller's cancelation test
Description
This scale assess USN by crossing letters H included with distractors. The number of letters crossed are calculated.
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Sex
Description
The sex of the participants is recorded at the start of the study
Time Frame
1 minute
Title
Date of birth
Description
The participant's date of birth is collected in order to calculate his age in years
Time Frame
1 minute
Title
Date of injury
Description
The date of the injury is registered in order to calculate the time of evolution with the disease
Time Frame
1 minute
Title
Type of injury
Description
Description of injury to analyse if it has some effect during intervention
Time Frame
1 minute
Title
Admission time
Description
Date of involvement in study
Time Frame
1 minute
Title
National Institutes of Health Stroke Scale
Description
is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 year old or older
Diagnosis of right stroke
Diagnosis of left heminegligence
Exclusion Criteria:
No cooperation and comunication problems
Uncontrolled epileptic seizures or migraines
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fátima Pérez-Robledo, Doctor
Phone
+34 619 885 479
Email
fatima_pr@usal.es
First Name & Middle Initial & Last Name or Official Title & Degree
Rocío Llamas-Ramos, Doctor
Phone
+34 657 854 188
Email
rociollamas@usal.es
Facility Information:
Facility Name
Universidad de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana M Martín-Nogueras
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
http://gredos.usal.es/
Learn more about this trial
Optokinetic Stimulation for Hemineglect
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