Innovative Physical Therapy Modalities in People With a Neurological Disease: Oculomotor Therapy and Adapted Yoga (NeuPhysioLRG)

May 11, 2023 updated by: Lidia Ramos Gaspar, University of Malaga

Prevention Program of Innovative Physiotherapy Techniques in People With a Physical Neurological Disease: Oculomotor Therapy and Adapted Yoga

Physiotherapy is a discipline which englobe not only the rehabilitation of physical pathologies but also their prevention. That is why this study pretends to upgrade this part of the physical therapy specialty while prove new therapies using innovation technologies in people with any physical neurological disease. The main problem that this study pretends to solve is the necessity of develop new activities to improve quality of life and integration in people with any physical neurological disease.

People with any neurological disease used to present visual problems, pain, fatigue, functional dependence, and a bad quality of life and it appears that exercise habits could improve all these deficiencies. However, how could people with any physical neurological disease participate in an integrated way in nowadays physical activities? The main objective of this study is to prove the effectiveness on visual acuity, quality of life, pain decreasing, functional independence and fatigue of physical therapy modalities in people with any physical neurological disease.

The experiment will take part with 128 participants, divided equally in control and experimental groups. Both are going to receive adapted yoga sessions but only experiment group is going to test oculomotor therapy. Descriptive investigation would take part at the end of the intervention to analyze all results.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants will complete several questionnaires at the start and at the end of the study, to quantify the progress. Also, a professional will evaluate the sessions.

Sessions are going to be online and offline, and both will be recorded (with the registered permission of the participants), so they could be analyzed lately.

Study Type

Interventional

Enrollment (Anticipated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Users equal or over 18 years old.
  • To have already signed all the obligatory documents.
  • To have a physical neurological disease.
  • To have an electronic with internet connection.
  • To collaborate on the correct develop of the project.

Exclusion Criteria:

  • Serious cognitive or physical damage.
  • Doctor disapproval.
  • Be unable to understand the indications.
  • Be unable to read.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Oculomotor therapy and adapted yoga.
Other: Oculomotor therapy
Visual exercise to improve oculomotor behavior.
Other Names:
  • Visual treatment
Other: Adapted yoga
Muscular Stretching Therapy, postural control, respiratory physiotherapy.
Other Names:
  • Yoga
Active Comparator: Active Comparator
Adapted yoga.
Other: Adapted yoga
Muscular Stretching Therapy, postural control, respiratory physiotherapy.
Other Names:
  • Yoga

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity (start point)
Time Frame: Baseline.
Visual acuity is going to be measured by reading performance, in which users must to read aloud a short text and examiner will count the number of words per second.
Baseline.
Visual acuity (final point)
Time Frame: At study completion, immediately after all the sessions, after 6 weeks.
Visual acuity is going to be measured by reading performance, in which users must to read aloud a short text and examiner will count the number of words per second.
At study completion, immediately after all the sessions, after 6 weeks.
Search strategy (first session)
Time Frame: Baseline, at first session.
Using flickering letters that users will explain to examiner, number, type, color and orientation.
Baseline, at first session.
Search strategy (through sessions)
Time Frame: Through study completion, an average of 6 weeks.
Using flickering letters that users will explain to examiner, number, type, color and orientation.
Through study completion, an average of 6 weeks.
Search strategy (sixth session)
Time Frame: At the final intervention, at 6 weeks.
Using flickering letters that users will explain to examiner, number, type, color and orientation.
At the final intervention, at 6 weeks.
Accomplishment registration
Time Frame: After the intervention, at 6 weeks.
Examiner will take note of the number of sessions carried out and their full compliance.
After the intervention, at 6 weeks.
Quality accomplishment registration
Time Frame: After the intervention, at 6 weeks.
Examiner will also take note of the quality of the accomplishment of the sessions: position, breathing and resistance.
After the intervention, at 6 weeks.
The McGill Pain Questionnaire (baseline)
Time Frame: Baseline.
It is a questionnaire to monitor the pain over time and to determine the effectiveness of the intervention. Total score: 0-45, where 0 means no dolor and 45 means the worse outcome.
Baseline.
The McGill Pain Questionnaire (final)
Time Frame: Immediately after the intervention, at 6 weeks.
It is a questionnaire to monitor the pain over time and to determine the effectiveness of the intervention. Total score: 0-45, where 0 means no dolor and 45 means the worse outcome.
Immediately after the intervention, at 6 weeks.
Modified Fatigue Impact Scale (MFIS) (baseline)
Time Frame: Baseline.
A questionnaire that serves to register the difference fatigue that users could feel after an exercise therapy program. Total score: 0-84, where 0 means no fatigue and 84 means the worse outcome.
Baseline.
Modified Fatigue Impact Scale (MFIS) (final)
Time Frame: Immediately after the intervention, at 6 weeks.
A questionnaire that serves to register the difference fatigue that users could feel after an exercise therapy program. Total score: 0-84, where 0 means no fatigue and 84 means the worse outcome.
Immediately after the intervention, at 6 weeks.
SF-36 health questionnaire (baseline)
Time Frame: Baseline.
A questionnaire that allows to quantify the quality of life of users. 36 items are measured. Total score: 0-100, where 0 means the worse score (bad health) and 100 means the better score.
Baseline.
SF-36 health questionnaire (final)
Time Frame: Immediately after the intervention, at 6 weeks.
A questionnaire that allows to quantify the quality of life of users. 36 items are measured. Total score: 0-100, where 0 means the worse score (bad health) and 100 means the better score.
Immediately after the intervention, at 6 weeks.
Functional Independence Measure (FIM) questionnaire (baseline)
Time Frame: Baseline.
A questionnaire that make possible to register the functional independence. FIM scores range from 1 to 7 (1 = total assist and 7 = complete independence).
Baseline.
Functional Independence Measure (FIM) questionnaire (final)
Time Frame: Immediately after the intervention, at 6 weeks.
A questionnaire that make possible to register the functional independence. FIM scores range from 1 to 7 (1 = total assist and 7 = complete independence).
Immediately after the intervention, at 6 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaga

Investigators

  • Study Director: Rocío Martín Valero, PhD, Universidad de Málaga

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 15, 2023

Primary Completion (Anticipated)

September 15, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

December 15, 2022

First Submitted That Met QC Criteria

January 23, 2023

First Posted (Actual)

February 2, 2023

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMalagaLR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

An average of 2 years.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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