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

NCT05709691 | Unknown

• 1 other identifier: UMalagaLR
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Nervous System Diseases; Oculomotor; Disorder; Physical Dependence; Physical Inactivity; Treatment Adherence

Keywords

Physical Therapy Modalities; Muscular Stretching Therapy; Oculomotor therapy; Adapted Yoga; Technologies

Outcome Measures

Primary Outcomes (15)

• Visual acuity (start point)

  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)

  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)

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

  Baseline, at first session.

• Search strategy (through sessions)

  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)

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

  At the final intervention, at 6 weeks.

• Accomplishment registration

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

  After the intervention, at 6 weeks.

• Quality accomplishment registration

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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.

Study Arms (2)

Experimental

EXPERIMENTAL

Oculomotor therapy and adapted yoga.

Other: Oculomotor therapy; Other: Adapted yoga

Active Comparator

ACTIVE COMPARATOR

Adapted yoga.

Other: Adapted yoga

Interventions

Oculomotor therapy OTHER

Visual exercise to improve oculomotor behavior.

Also known as: Visual treatment

Experimental

Adapted yoga OTHER

Muscular Stretching Therapy, postural control, respiratory physiotherapy.

Also known as: Yoga

Active Comparator; Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Malaga: lead

Study Sites (1)

Universidad de Málaga

Málaga, 29071, Spain

Location

MeSH Terms

Conditions

Nervous System Diseases; Sedentary Behavior; Treatment Adherence and Compliance

Interventions

Yoga

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Rocío Martín Valero, PhD

  Universidad de Málaga

  STUDY DIRECTOR

Central Study Contacts

Lidia Ramos Gaspar

CONTACT

627330136; lidiaramosgaspar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will not know in which group they are, oculomotor therapy will only be used in the experimental group.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: February 2, 2023
• Study Start: June 15, 2023
• Primary Completion: September 15, 2023
• Study Completion: December 30, 2023
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)