Nervous System DiseasesNeuPhysioLRGNCT05709691
Innovative Physical Therapy Modalities in People With a Neurological Disease: Oculomotor Therapy and Adapted Yoga
A study testing Oculomotor therapy and Adapted yoga in people with Nervous System Diseases and Oculomotor; Disorder, run by University of Malaga at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nervous System Diseases, Oculomotor; Disorder, Physical Dependence
- What is being tested?
- Oculomotor therapy and Adapted yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jun 2023to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Serious cognitive or physical damage.
- Doctor disapproval.
- Be unable to understand the indications.
- Be unable to read.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universidad de Málaga
Málaga, 29071
Lidia Ramos Gaspar, 627330136, lidiaramosgaspar@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Nervous System Diseases, Oculomotor; Disorder, Physical Dependence, Physical Inactivity, Treatment Adherence
- Being tested
- Oculomotor therapy, Adapted yoga
- Keywords
- Physical Therapy Modalities, Muscular Stretching Therapy, Oculomotor therapy, Adapted Yoga, Technologies
- Medical subject headings
- Nervous System Diseases, Sedentary Behavior, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oculomotor therapyOther
Also called Visual treatment
Visual exercise to improve oculomotor behavior.
Adapted yogaOther
Also called Yoga
Muscular Stretching Therapy, postural control, respiratory physiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Oculomotor therapy and adapted yoga. Receives: Other: Oculomotor therapy; Other: Adapted yoga |
| Active Comparator | Active comparator | Adapted yoga. Receives: Other: Adapted yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, at first session.
Search strategy (through sessions)
Using flickering letters that users will explain to examiner, number, type, color and orientation.
Measured: 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.
Measured: At the final intervention, at 6 weeks.
Accomplishment registration
Examiner will take note of the number of sessions carried out and their full compliance.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Immediately after the intervention, at 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start15 Jun 2023 (estimated)
- Primary completion15 Sep 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nervous System DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lidia Ramos Gaspar, University of Malaga
- Investigators
- Rocío Martín Valero, PhD, Study director, Universidad de Málaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709691
- Sponsor's protocol ID
- UMalagaLR
- Acronym
- NeuPhysioLRG
- Status last verified
- May 2023
- First submitted
- 15 Dec 2022
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: An average of 2 years.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention Program of Innovative Physiotherapy Techniques in People With a Physical Neurological Disease: Oculomotor Therapy and Adapted Yoga
- ClinicalTrials.gov ID
- NCT05709691
- Acronym / sponsor ID
- NeuPhysioLRG / UMalagaLR
- Conditions
- Nervous System Diseases, Oculomotor; Disorder, Physical Dependence, Physical Inactivity, Treatment Adherence
- Keywords
- Physical Therapy Modalities, Muscular Stretching Therapy, Oculomotor therapy, Adapted Yoga, Technologies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 15 Jun 2023 (estimated)
- Primary completion
- 15 Sep 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Oculomotor therapy, Other: Adapted yogaOculomotor therapy and adapted yoga. |
| Active Comparator | Active comparator | Other: Adapted yogaAdapted yoga. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Serious cognitive or physical damage.
- Doctor disapproval.
- Be unable to understand the indications.
- Be unable to read.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oculomotor therapyAlso: Visual treatmentVisual exercise to improve oculomotor behavior. | Other | Experimental |
| Adapted yogaAlso: YogaMuscular Stretching Therapy, postural control, respiratory physiotherapy. | Other | Active Comparator, Experimental |
Primary outcome
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.
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.
Search strategy (first session)
Time frame: Baseline, at first session.
Using flickering letters that users will explain to examiner, number, type, color and orientation.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Individual participant dataSharing planned: No. An average of 2 years.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rocío Martín Valero, PhD study director
Universidad de Málaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oculomotor therapy and Adapted yoga in people with Nervous System Diseases and Oculomotor; Disorder, run by University of Malaga at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lidia Ramos Gaspar (627330136, lidiaramosgaspar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (start point) (time frame: Baseline.). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.