Prevention Program of Innovative Physiotherapy Techniques in People With a Physical Neurological Disease: Oculomotor Therapy and Adapted Yoga
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Quality accomplishment registration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants will not know in which group they are, oculomotor therapy will only be used in the experimental group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Serious cognitive or physical damage.
- •Doctor disapproval.
- •Be unable to understand the indications.
- •Be unable to read.
结局指标
主要结局
Quality accomplishment registration
时间窗: After the intervention, at 6 weeks.
Examiner will also take note of the quality of the accomplishment of the sessions: position, breathing and resistance.
Modified Fatigue Impact Scale (MFIS) (final)
时间窗: 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)
时间窗: 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.
Search strategy (first session)
时间窗: Baseline, at first session.
Using flickering letters that users will explain to examiner, number, type, color and orientation.
Search strategy (through sessions)
时间窗: 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)
时间窗: At the final intervention, at 6 weeks.
Using flickering letters that users will explain to examiner, number, type, color and orientation.
Accomplishment registration
时间窗: After the intervention, at 6 weeks.
Examiner will take note of the number of sessions carried out and their full compliance.
Visual acuity (final point)
时间窗: 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.
Modified Fatigue Impact Scale (MFIS) (baseline)
时间窗: 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.
SF-36 health questionnaire (final)
时间窗: 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 (final)
时间窗: 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).
Visual acuity (start point)
时间窗: 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.
The McGill Pain Questionnaire (baseline)
时间窗: 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)
时间窗: 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.
Functional Independence Measure (FIM) questionnaire (baseline)
时间窗: 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).
次要结局
未报告次要终点
研究者
Lidia Ramos Gaspar
Principal Investigator
University of Malaga