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

Sponsor
University of Malaga (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05709691
Collaborator
(none)
128
1
2
10.4
12.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Oculomotor therapy
  • Other: Adapted yoga
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
128 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
128 participants were randomized to follow a physiotherapy online program for 6 weeks. Participants will not know in which group they are, oculomotor therapy will only be used in the experimental group. The results will be measured at the end of the study.128 participants were randomized to follow a physiotherapy online program for 6 weeks. Participants will not know in which group they are, oculomotor therapy will only be used in the experimental group. The results will be measured at the end of the study.
Masking:
Single (Outcomes Assessor)
Masking Description:
Participants will not know in which group they are, oculomotor therapy will only be used in the experimental group.
Primary Purpose:
Treatment
Official Title:
Prevention Program of Innovative Physiotherapy Techniques in People With a Physical Neurological Disease: Oculomotor Therapy and Adapted Yoga
Anticipated Study Start Date :
Feb 15, 2023
Anticipated Primary Completion Date :
Jul 15, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Visual acuity (start point) [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.

    2. Visual acuity (final point) [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.

    3. Search strategy (first session) [Baseline, at first session.]

      Using flickering letters that users will explain to examiner, number, type, color and orientation.

    4. Search strategy (through sessions) [Through study completion, an average of 6 weeks.]

      Using flickering letters that users will explain to examiner, number, type, color and orientation.

    5. Search strategy (sixth session) [At the final intervention, at 6 weeks.]

      Using flickering letters that users will explain to examiner, number, type, color and orientation.

    6. Accomplishment registration [After the intervention, at 6 weeks.]

      Examiner will take note of the number of sessions carried out and their full compliance.

    7. Quality accomplishment registration [After the intervention, at 6 weeks.]

      Examiner will also take note of the quality of the accomplishment of the sessions: position, breathing and resistance.

    8. The McGill Pain Questionnaire (baseline) [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.

    9. The McGill Pain Questionnaire (final) [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.

    10. Modified Fatigue Impact Scale (MFIS) (baseline) [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.

    11. Modified Fatigue Impact Scale (MFIS) (final) [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.

    12. SF-36 health questionnaire (baseline) [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.

    13. SF-36 health questionnaire (final) [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.

    14. Functional Independence Measure (FIM) questionnaire (baseline) [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).

    15. Functional Independence Measure (FIM) questionnaire (final) [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).

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universidad de Málaga Málaga Spain 29071

    Sponsors and Collaborators

    • University of Malaga

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lidia Ramos Gaspar, Principal Investigator, University of Malaga
    ClinicalTrials.gov Identifier:
    NCT05709691
    Other Study ID Numbers:
    • UMalagaLR
    First Posted:
    Feb 2, 2023
    Last Update Posted:
    Feb 2, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Lidia Ramos Gaspar, Principal Investigator, University of Malaga
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 2, 2023