Clinical trial NCT05709691: Innovative Physical Therapy Modalities in People With a Neurological Disease: Oculomotor Therapy and Adapted Yoga
Official title: Prevention Program of Innovative Physiotherapy Techniques in People With a Physical Neurological Disease: Oculomotor Therapy and Adapted Yoga
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nervous System Diseases
Oculomotor; Disorder
Physical Dependence
Physical Inactivity
Treatment Adherence
Keywords: Physical Therapy Modalities
Muscular Stretching Therapy
Oculomotor therapy
Adapted Yoga
Technologies
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual acuity (start point)
timeFrame: Baseline.
measure: Visual acuity (final point)
timeFrame: At study completion, immediately after all the sessions, after 6 weeks.
measure: Search strategy (first session)
timeFrame: Baseline, at first session.
measure: Search strategy (through sessions)
timeFrame: Through study completion, an average of 6 weeks.
measure: Search strategy (sixth session)
timeFrame: At the final intervention, at 6 weeks.
measure: Accomplishment registration
timeFrame: After the intervention, at 6 weeks.
measure: Quality accomplishment registration
timeFrame: After the intervention, at 6 weeks.
measure: The McGill Pain Questionnaire (baseline)
timeFrame: Baseline.
measure: The McGill Pain Questionnaire (final)
timeFrame: Immediately after the intervention, at 6 weeks.
measure: Modified Fatigue Impact Scale (MFIS) (baseline)
timeFrame: Baseline.
measure: Modified Fatigue Impact Scale (MFIS) (final)
timeFrame: Immediately after the intervention, at 6 weeks.
measure: SF-36 health questionnaire (baseline)
timeFrame: Baseline.
measure: SF-36 health questionnaire (final)
timeFrame: Immediately after the intervention, at 6 weeks.
measure: Functional Independence Measure (FIM) questionnaire (baseline)
timeFrame: Baseline.
measure: Functional Independence Measure (FIM) questionnaire (final)
timeFrame: Immediately after the intervention, at 6 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Universidad de Málaga
Study officials:
affiliation: Universidad de Málaga
name: Rocío Martín Valero, PhD
role: STUDY_DIRECTOR
References: