Optokinetic Stimulation for Hemineglect

NCT ID: NCT04663646

Last Updated: 2023-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-10

Study Completion Date

2023-12-28

Brief Summary

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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.

Detailed Description

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Conditions

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Perceptual Disorders Unilateral Spatial Neglect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial in which an intervention group will undergo optokinetic stimulation with virtual reality glasses, and the control group will receive placebo sessions.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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Intervention Group

Group Type EXPERIMENTAL

Optokinetic stimulation

Intervention Type OTHER

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.

Control Group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Salamanca

OTHER

Sponsor Role lead

Responsible Party

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Pérez-Robledo, Fátima

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidad de Salamanca

Salamanca, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Fátima Pérez-Robledo, Doctor

Role: CONTACT

+34 619 885 479

Rocío Llamas-Ramos, Doctor

Role: CONTACT

+34 657 854 188

Facility Contacts

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Ana M Martín-Nogueras

Role: primary

References

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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.

Reference Type DERIVED
PMID: 37518082 (View on PubMed)

Other Identifiers

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NEUROUSAL02/2020

Identifier Type: -

Identifier Source: org_study_id

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