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

Physical Inactivity Clinical Trial

— NeuPhysioLRG  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05709691
• Other study ID #: UMalagaLR
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2023
• Source: University of Malaga
• Contact: Lidia Ramos Gaspar
• Phone: 627330136
• Email: lidiaramosgaspar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 128
• Est. completion date: December 30, 2023
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Oculomotor therapy
Visual exercise to improve oculomotor behavior.
• Adapted yoga
Muscular Stretching Therapy, postural control, respiratory physiotherapy.

Locations

Country	Name	City	State
Spain	Universidad de Málaga	Málaga

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaga

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	Search strategy (first session)	Using flickering letters that users will explain to examiner, number, type, color and orientation.	Baseline, at first session.
Primary	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.
Primary	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.
Primary	Accomplishment registration	Examiner will take note of the number of sessions carried out and their full compliance.	After the intervention, at 6 weeks.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.