Optokinetic Stimulation for Hemineglect

Perceptual Disorders Clinical Trial

Official title:

Application of Optokinetic Stimulation in the Treatment of Hemineglect

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04663646
• Other study ID #: NEUROUSAL02/2020
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2023
• Est. completion date: December 28, 2023

Study information

• Verified date: July 2023
• Source: University of Salamanca
• Contact: Fátima Pérez-Robledo, Doctor
• Phone: +34 619 885 479
• Email: fatima_pr[@]usal.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: December 28, 2023
• Est. primary completion date: December 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Perceptual Disorders
• Unilateral Spatial Neglect

Intervention

Other:
• Optokinetic stimulation
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.
• Placebo
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.

Locations

Country	Name	City	State
Spain	Universidad de Salamanca	Salamanca

Sponsors (1)

Lead Sponsor	Collaborator
University of Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Fugl Meyer Assessment Scale	This scale assess upper limb, lower limb, balance, sensibility, range of motion and pain in patients with stroke.	60 minutes
Primary	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
Primary	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	Sex	The sex of the participants is recorded at the start of the study	1 minute
Secondary	Date of birth	The participant's date of birth is collected in order to calculate his age in years	1 minute
Secondary	Date of injury	The date of the injury is registered in order to calculate the time of evolution with the disease	1 minute
Secondary	Type of injury	Description of injury to analyse if it has some effect during intervention	1 minute
Secondary	Admission time	Date of involvement in study	1 minute
Secondary	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.	10 minutes