Optokinetic Stimulation for Hemineglect

Sponsor
University of Salamanca (Other)
Overall Status
Recruiting
CT.gov ID
NCT04663646
Collaborator
(none)
102
1
2
7.5
13.7

Study Details

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 in different experimental conditions, where the speed of the stimulus and the attention to it will be varied, to see its influence on the recovery of this sequel of stroke.

Condition or Disease Intervention/Treatment Phase
  • Other: Optokinetic stimulation
  • Other: Placebo
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
102 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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:
Double (Participant, Investigator)
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.
Primary Purpose:
Treatment
Official Title:
Application of Optokinetic Stimulation in the Treatment of Hemineglect
Actual Study Start Date :
May 15, 2022
Anticipated Primary Completion Date :
Dec 28, 2022
Anticipated Study Completion Date :
Dec 28, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Group

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 in four different experimental conditions. These conditions will be determined by the speed of stimulation and by the voluntary or unwilling attention of the subject during the intervention. Each participant will be exposed to Slow Optokinetic Stimulation without Attention (SOKS -), Fast Optokinetic Stimulation without Attention (FOKS -), Slow Optokinetic Stimulation with Attention (SOKS +) and Fast Optokinetic Stimulation with Attention (FOKS +). The interventions will be carried out on different days with a separation between them of at least one week. Fast stimulations will be performed at 60º / second and slow ones at 10º / second. In the conditions with attention, the participants will be asked to detect changes that will occur in the stimulus.

Placebo Comparator: Control Group

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 virtual reality video projection, in which they will visualize a walk through the forest.

Outcome Measures

Primary Outcome Measures

  1. Posture [60 minutes]

    To analyze static posture, a Carbon 5 Flex® pressure platform will be used. It will be measured before and after the application of each experimental situation

  2. Stability [60 minutes]

    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

  3. Fluff Test [60 minutes]

    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

  4. Bisection of the line [60 minutes]

    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

  5. Motor extinction [60 minutes]

    It is a phenomenon that occurs when the patient is stimulated in both extremities and is asked to move the one he has felt. The patient verbally expresses having felt the stimulation on both sides but only moves his right limb. To assess its presence, it is recorded whether participant is able to move both limbs when receiving bilateral stimulation or not. It will be measured before and after the application of each experimental situation

  6. Motor Impersistence [60 minutes]

    It determines the affectation of attention on motor activities. To assess it, participant is asked to maintain a motor activity (eyes closed, mouth open, arm raised) and it is observed if it is capable of doing it for at least 10 seconds. It will be measured before and after the application of each experimental situation

Secondary Outcome Measures

  1. Sex [1 minute]

    The sex of the participants is recorded at the start of the study

  2. Date of birth [1 minute]

    The participant's date of birth is collected in order to calculate his age in years

  3. Date of injury [1 minute]

    The date of the injury is registered in order to calculate the time of evolution with the disease

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universidad de Salamanca Salamanca Spain 37007

Sponsors and Collaborators

  • University of Salamanca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pérez-Robledo, Fátima, Dr., University of Salamanca
ClinicalTrials.gov Identifier:
NCT04663646
Other Study ID Numbers:
  • NEUROUSAL02/2020
First Posted:
Dec 11, 2020
Last Update Posted:
May 24, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pérez-Robledo, Fátima, Dr., University of Salamanca
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 24, 2022