- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05401734
Robot Assisted Gait Training in Persons With a Spinal Cord Injury
Over the past decade, RAGT has emerged as a promising method for improving ambulation after spinal cord injury (SCI). Early reports of this therapy were very promising, yet a recent study suggested that even though RAGT may improve locomotor ability in the acute SCI population, it appears less functional to more conventional forms of ambulation such as wheelchair propulsion.
What most of these studies have neglected to address, however, is the efficacy of RAGT as a therapeutic exercise intervention for the SCI population. Indeed, persons with SCI lead by definition a sedentary lifestyle. This reduced activity can lead to a variety of secondary health complications, including an increased risk for cardiovascular disease, spasticity, altered muscle composition and reduced joint range of motion (ROM), increased risk for pressure sores, reduced bone mineral density, increased risk for osteoporosis, and bladder and bowel dysfunction. In addition, psychological components such as body image, self-esteem, self-efficacy, psychological well-being and quality of life in general may be affected.
Consequently, before RAGT is dismissed as an expensive but perhaps not superior alternative to conventional rehabilitation strategies after SCI, the potential effect of this therapy on a variety of health-related outcomes needs to be considered, and the potential physiological and psychological benefits associated with this whole-body upright exercise therapy may justify its use in both the acute and chronic SCI populations. Several investigations have already indicated that regular exposure to RAGT results in some very significant health-related benefits that may decrease the aforementioned risk of secondary health complications. To our knowledge however, longitudinal effect studies in the SCI population have not yet been conducted, and further studies are needed to provide definitive evidence. It can be assumed that such insights may further optimize long-term health benefits, but also the cost-benefit ratio of RAGT. In addition, a detailed analysis of RAGT parameters (walking time, crutch position, forward and lateral center of gravity shift, step length and height, swing phase, walking speed, etc.) and the direct cardiovascular response (heart frequency, blood pressure, blood lactate concentration) to RAGT have not yet been conducted.
The purpose of this research project is therefore to investigate the longitudinal effect of RAGT on the psychological well-being (Quality of Life, pain, fatigue), independence in activities of daily living, muscular strength and joint range of motion (ROM), and bladder and bowel function in persons with SCI.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Over the past decade, RAGT has emerged as a promising method for improving ambulation after spinal cord injury (SCI). Early reports of this therapy were very promising, yet a recent study suggested that even though RAGT may improve locomotor ability in the acute SCI population, it appears less functional to more conventional forms of ambulation such as wheelchair propulsion.
What most of these studies have neglected to address, however, is the efficacy of RAGT as a therapeutic exercise intervention for the SCI population. Indeed, persons with SCI lead by definition a sedentary lifestyle. This reduced activity can lead to a variety of secondary health complications, including an increased risk for cardiovascular disease, spasticity, altered muscle composition and reduced joint range of motion (ROM), increased risk for pressure sores, reduced bone mineral density, increased risk for osteoporosis, and bladder and bowel dysfunction. In addition, psychological components such as body image, self-esteem, self-efficacy, psychological well-being and quality of life in general may be affected.
Consequently, before RAGT is dismissed as an expensive but perhaps not superior alternative to conventional rehabilitation strategies after SCI, the potential effect of this therapy on a variety of health-related outcomes needs to be considered, and the potential physiological and psychological benefits associated with this whole-body upright exercise therapy may justify its use in both the acute and chronic SCI populations. Several investigations have already indicated that regular exposure to RAGT results in some very significant health-related benefits that may decrease the aforementioned risk of secondary health complications. To our knowledge however, longitudinal effect studies in the SCI population have not yet been conducted, and further studies are needed to provide definitive evidence. It can be assumed that such insights may further optimize long-term health benefits, but also the cost-benefit ratio of RAGT. In addition, a detailed analysis of RAGT parameters (walking time, crutch position, forward and lateral center of gravity shift, step length and height, swing phase, walking speed, etc.) and the direct cardiovascular response (heart frequency, blood pressure, blood lactate concentration) to RAGT have not yet been conducted.
The purpose of this research project is therefore to investigate the longitudinal effect of RAGT on the psychological well-being (Quality of Life, pain, fatigue), independence in activities of daily living, muscular strength and joint range of motion (ROM), and bladder and bowel function in persons with SCI over a period of 2 years in several cohorts. We will measure every three months. Patients will be asked to fill in the questionnaires 3, 6 9, 12, 15, 18, 21 and 24 months after inclusion. Additionally the patients will we asked to fill in his medication intake in the follow-up system.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Antwerp
-
Geel, Antwerp, Bélgica, 2440
- Reclutamiento
- De Maesschalck Lieven
-
Contacto:
- Lieven De Maesschalck
- Número de teléfono: 0479911974
- Correo electrónico: lieven.demaesschalck@thomasmore.be
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- SCI
- Bone density
Exclusion Criteria:
- osteoporosis
- length more than 2 meter
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
Cohort 1
Approximately 10 persons with a SCI will be included in the study.
All participants are persons included in the RAGT program organized by the To Walk Again Postrehabilitation Centre.
The recruitment will be performed by word of mouth.
Participants utilizing the Eksoskeleton at the To Walk Again Postrehabilitation Centre will be asked if they are willing to participate in this study.
Participation will be strictly voluntary
|
The measured variables include: Questionnaires
Measurements:
|
Cohort 2
Approximately 10 persons with a SCI will be included in the study.
All participants are persons included in the RAGT program organized by the To Walk Again Postrehabilitation Centre.
The recruitment will be performed by word of mouth.
Participants utilizing the Eksoskeleton at the To Walk Again Postrehabilitation Centre will be asked if they are willing to participate in this study.
Participation will be strictly voluntary
|
The measured variables include: Questionnaires
Measurements:
|
Cohort 3
Approximately 10 persons with a SCI will be included in the study.
All participants are persons included in the RAGT program organized by the To Walk Again Postrehabilitation Centre.
The recruitment will be performed by word of mouth.
Participants utilizing the Eksoskeleton at the To Walk Again Postrehabilitation Centre will be asked if they are willing to participate in this study.
Participation will be strictly voluntary
|
The measured variables include: Questionnaires
Measurements:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
ROM (Range of Motion)
Periodo de tiempo: 3 months
|
Range of Motion.
We measure the range of motion of the legs with a Goniometer every three months.
Our goal is to see if there is an improvement due to the robot asssited gait training
|
3 months
|
ROM (Range of Motion)
Periodo de tiempo: 6 months
|
Range of Motion.
We measure the range of motion of the legs with a Goniometer every three months.
Our goal is to see if there is an improvement due to the robot asssited gait training
|
6 months
|
ROM (Range of Motion)
Periodo de tiempo: 9 months
|
Range of Motion.
We measure the range of motion of the legs with a Goniometer every three months.
Our goal is to see if there is an improvement due to the robot asssited gait training
|
9 months
|
ROM (Range of Motion)
Periodo de tiempo: 12 months
|
Range of Motion.
We measure the range of motion of the legs with a Goniometer every three months.
Our goal is to see if there is an improvement due to the robot asssited gait training
|
12 months
|
ROM (Range of Motion)
Periodo de tiempo: 15 months
|
Range of Motion.
We measure the range of motion of the legs with a Goniometer every three months.
Our goal is to see if there is an improvement due to the robot asssited gait training
|
15 months
|
ROM (Range of Motion)
Periodo de tiempo: 18 months
|
Range of Motion.
We measure the range of motion of the legs with a Goniometer every three months.
Our goal is to see if there is an improvement due to the robot asssited gait training
|
18 months
|
ROM (Range of Motion)
Periodo de tiempo: 21 months
|
Range of Motion.
We measure the range of motion of the legs with a Goniometer every three months.
Our goal is to see if there is an improvement due to the robot asssited gait training
|
21 months
|
ROM (Range of Motion)
Periodo de tiempo: 24 months
|
Range of Motion.
We measure the range of motion of the legs with a Goniometer every three months.
Our goal is to see if there is an improvement due to the robot asssited gait training
|
24 months
|
WHOQOL
Periodo de tiempo: 3 months
|
World Health Organization Qualitiy of Life Questionnaire - BREF (WHOQoL-BREF).
We are using the WHOQOL-Bref instrument (questionnaire).
The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally.
WHOQOL-BREF is a generic health related QoL measure consisting of 26 items divided into 6 sub-scales.
It has 4 domains namely physical health, psychological health, social relationship and environment, and 2 individual subscales on overall quality of life and general health.
It can be self-administered and has good internal consistency (0.75-0.87).
The higher the score, the more QOL.
Each item is scored between 1 and 5.
This scores will be translated to a score between 0-100 based on the manual for the general score and each subdomain score.
This questionnaire will be filled in every three months by the patient.
|
3 months
|
WHOQOL
Periodo de tiempo: 6 months
|
World Health Organization Qualitiy of Life Questionnaire - BREF (WHOQoL-BREF).
We are using the WHOQOL-Bref instrument (questionnaire).
The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally.
WHOQOL-BREF is a generic health related QoL measure consisting of 26 items divided into 6 sub-scales.
It has 4 domains namely physical health, psychological health, social relationship and environment, and 2 individual subscales on overall quality of life and general health.
It can be self-administered and has good internal consistency (0.75-0.87).
The higher the score, the more QOL.
Each item is scored between 1 and 5.
This scores will be translated to a score between 0-100 based on the manual for the general score and each subdomain score.
This questionnaire will be filled in every three months by the patient.
|
6 months
|
WHOQOL
Periodo de tiempo: 9 months
|
World Health Organization Qualitiy of Life Questionnaire - BREF (WHOQoL-BREF).
We are using the WHOQOL-Bref instrument (questionnaire).
The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally.
WHOQOL-BREF is a generic health related QoL measure consisting of 26 items divided into 6 sub-scales.
It has 4 domains namely physical health, psychological health, social relationship and environment, and 2 individual subscales on overall quality of life and general health.
It can be self-administered and has good internal consistency (0.75-0.87).
The higher the score, the more QOL.
Each item is scored between 1 and 5.
This scores will be translated to a score between 0-100 based on the manual for the general score and each subdomain score.
This questionnaire will be filled in every three months by the patient.
|
9 months
|
WHOQOL
Periodo de tiempo: 12 months
|
World Health Organization Qualitiy of Life Questionnaire - BREF (WHOQoL-BREF).
We are using the WHOQOL-Bref instrument (questionnaire).
The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally.
WHOQOL-BREF is a generic health related QoL measure consisting of 26 items divided into 6 sub-scales.
It has 4 domains namely physical health, psychological health, social relationship and environment, and 2 individual subscales on overall quality of life and general health.
It can be self-administered and has good internal consistency (0.75-0.87).
The higher the score, the more QOL.
Each item is scored between 1 and 5.
This scores will be translated to a score between 0-100 based on the manual for the general score and each subdomain score.
This questionnaire will be filled in every three months by the patient.
|
12 months
|
WHOQOL
Periodo de tiempo: 15 months
|
World Health Organization Qualitiy of Life Questionnaire - BREF (WHOQoL-BREF).
We are using the WHOQOL-Bref instrument (questionnaire).
The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally.
WHOQOL-BREF is a generic health related QoL measure consisting of 26 items divided into 6 sub-scales.
It has 4 domains namely physical health, psychological health, social relationship and environment, and 2 individual subscales on overall quality of life and general health.
It can be self-administered and has good internal consistency (0.75-0.87).
The higher the score, the more QOL.
Each item is scored between 1 and 5.
This scores will be translated to a score between 0-100 based on the manual for the general score and each subdomain score.
This questionnaire will be filled in every three months by the patient.
|
15 months
|
WHOQOL
Periodo de tiempo: 18 months
|
World Health Organization Qualitiy of Life Questionnaire - BREF (WHOQoL-BREF).
We are using the WHOQOL-Bref instrument (questionnaire).
The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally.
WHOQOL-BREF is a generic health related QoL measure consisting of 26 items divided into 6 sub-scales.
It has 4 domains namely physical health, psychological health, social relationship and environment, and 2 individual subscales on overall quality of life and general health.
It can be self-administered and has good internal consistency (0.75-0.87).
The higher the score, the more QOL.
Each item is scored between 0 and 5.
This scores will be translated to a score between 0-100 based on the manual for the general score and each subdomain score.
This questionnaire will be filled in every three months by the patient.
|
18 months
|
WHOQOL
Periodo de tiempo: 21 months
|
World Health Organization Qualitiy of Life Questionnaire - BREF (WHOQoL-BREF).
We are using the WHOQOL-Bref instrument (questionnaire).
The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally.
WHOQOL-BREF is a generic health related QoL measure consisting of 26 items divided into 6 sub-scales.
It has 4 domains namely physical health, psychological health, social relationship and environment, and 2 individual subscales on overall quality of life and general health.
It can be self-administered and has good internal consistency (0.75-0.87).
The higher the score, the more QOL.
Each item is scored between 1 and 5.
This scores will be translated to a score between 0-100 based on the manual for the general score and each subdomain score.
This questionnaire will be filled in every three months by the patient.
|
21 months
|
WHOQOL
Periodo de tiempo: 24 months
|
World Health Organization Qualitiy of Life Questionnaire - BREF (WHOQoL-BREF).
We are using the WHOQOL-Bref instrument (questionnaire).
The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally.
WHOQOL-BREF is a generic health related QoL measure consisting of 26 items divided into 6 sub-scales.
It has 4 domains namely physical health, psychological health, social relationship and environment, and 2 individual subscales on overall quality of life and general health.
It can be self-administered and has good internal consistency (0.75-0.87).
The higher the score, the more QOL.
Each item is scored between 1 and 5.
This scores will be translated to a score between 0-100 based on the manual for the general score and each subdomain score.
This questionnaire will be filled in every three months by the patient.
|
24 months
|
IPA
Periodo de tiempo: 3 months
|
Participation of daily life (IPA).
This is a valid and reliable questionnaire (Impact on participation and autonomy).
This questionnaire is based on the international classification of human functioning.
The goal of of this questionnaire is to have a clear image on the way your healthy status influences your abilities to live your life and how you experience this feeling.
This questionnaire consist of 32 items divided in 5 domains.
(Autonomy outside, family roll, autonomy inside, social relations, work and education).
Scores for each item are between 0 to 4. The lower the score the better; the higher the score the more barriers.
For each domain a mean score between 0 and 4 will be calculated.
|
3 months
|
IPA
Periodo de tiempo: 6 months
|
Participation of daily life (IPA).
This is a valid and reliable questionnaire (Impact on participation and autonomy).
This questionnaire is based on the international classification of human functioning.
The goal of of this questionnaire is to have a clear image on the way your healthy status influences your abilities to live your life and how you experience this feeling.
This questionnaire consist of 32 items divided in 5 domains.
(Autonomy outside, family roll, autonomy inside, social relations, work and education).
Scores for each item are between 0 to 4. The lower the score the better; the higher the score the more barriers.
For each domain a mean score between 0 and 4 will be calculated.
|
6 months
|
IPA
Periodo de tiempo: 9 months
|
Participation of daily life (IPA).
This is a valid and reliable questionnaire (Impact on participation and autonomy).
This questionnaire is based on the international classification of human functioning.
The goal of of this questionnaire is to have a clear image on the way your healthy status influences your abilities to live your life and how you experience this feeling.
This questionnaire consist of 32 items divided in 5 domains.
(Autonomy outside, family roll, autonomy inside, social relations, work and education).
Scores for each item are between 0 to 4. The lower the score the better; the higher the score the more barriers.
For each domain a mean score between 0 and 4 will be calculated.
|
9 months
|
IPA
Periodo de tiempo: 12 months
|
Participation of daily life (IPA).
This is a valid and reliable questionnaire (Impact on participation and autonomy).
This questionnaire is based on the international classification of human functioning.
The goal of of this questionnaire is to have a clear image on the way your healthy status influences your abilities to live your life and how you experience this feeling.
This questionnaire consist of 32 items divided in 5 domains.
(Autonomy outside, family roll, autonomy inside, social relations, work and education).
Scores for each item are between 0 to 4. The lower the score the better; the higher the score the more barriers.
For each domain a mean score between 0 and 4 will be calculated.
|
12 months
|
IPA
Periodo de tiempo: 15 months
|
Participation of daily life (IPA).
This is a valid and reliable questionnaire (Impact on participation and autonomy).
This questionnaire is based on the international classification of human functioning.
The goal of of this questionnaire is to have a clear image on the way your healthy status influences your abilities to live your life and how you experience this feeling.
This questionnaire consist of 32 items divided in 5 domains.
(Autonomy outside, family roll, autonomy inside, social relations, work and education).
Scores for each item are between 0 to 4. The lower the score the better; the higher the score the more barriers.
For each domain a mean score between 0 and 4 will be calculated.
|
15 months
|
IPA
Periodo de tiempo: 18 months
|
Participation of daily life (IPA).
This is a valid and reliable questionnaire (Impact on participation and autonomy).
This questionnaire is based on the international classification of human functioning.
The goal of of this questionnaire is to have a clear image on the way your healthy status influences your abilities to live your life and how you experience this feeling.
This questionnaire consist of 32 items divided in 5 domains.
(Autonomy outside, family roll, autonomy inside, social relations, work and education).
Scores for each item are between 0 to 4. The lower the score the better; the higher the score the more barriers.
For each domain a mean score between 0 and 4 will be calculated.
|
18 months
|
IPA
Periodo de tiempo: 21 months
|
Participation of daily life (IPA).
This is a valid and reliable questionnaire (Impact on participation and autonomy).
This questionnaire is based on the international classification of human functioning.
The goal of of this questionnaire is to have a clear image on the way your healthy status influences your abilities to live your life and how you experience this feeling.
This questionnaire consist of 32 items divided in 5 domains.
(Autonomy outside, family roll, autonomy inside, social relations, work and education).
Scores for each item are between 0 to 4. The lower the score the better; the higher the score the more barriers.
For each domain a mean score between 0 and 4 will be calculated.
|
21 months
|
IPA
Periodo de tiempo: 24 months
|
Participation of daily life (IPA).
This is a valid and reliable questionnaire (Impact on participation and autonomy).
This questionnaire is based on the international classification of human functioning.
The goal of of this questionnaire is to have a clear image on the way your healthy status influences your abilities to live your life and how you experience this feeling.
This questionnaire consist of 32 items divided in 5 domains.
(Autonomy outside, family roll, autonomy inside, social relations, work and education).
Scores for each item are between 0 to 4. The lower the score the better; the higher the score the more barriers.
For each domain a mean score between 0 and 4 will be calculated.
|
24 months
|
Bowel and bladder function
Periodo de tiempo: 3 months
|
We will use the Neurogenic Bowel Dysfunction score.
This valid and reliable questionnaire consist of 10 items.
The minimum score is 0 the maximum score is 47.
The higher the score, the more discomfort.
0-6: very less; Score 7-9: Minimal; Score 10-13: Moderate, Score 14+: severe.
For urinary we use the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol).
The ICIQ-LUTSqol is a psychometrically robust patient-completed questionnaire evaluating quality of life (QoL) in urinary incontinent patients.
The ICIQ-LUTSqol is the King's Health Questionnaire (KHQ) adapted for use within the ICIQ structure and provides a measure to assess the impact of urinary incontinence on quality of life with particular reference to social effects.
It consists 20 items sore between 0-10).
19-76 overall score with greater values indicating increased impact on quality of life.
|
3 months
|
Bowel and bladder function
Periodo de tiempo: 6 months
|
We will use the Neurogenic Bowel Dysfunction score.
This valid and reliable questionnaire consist of 10 items.
The minimum score is 0 the maximum score is 47.
The higher the score, the more discomfort.
0-6: very less; Score 7-9: Minimal; Score 10-13: Moderate, Score 14+: severe.
For urinary we use the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol).
The ICIQ-LUTSqol is a psychometrically robust patient-completed questionnaire evaluating quality of life (QoL) in urinary incontinent patients.
The ICIQ-LUTSqol is the King's Health Questionnaire (KHQ) adapted for use within the ICIQ structure and provides a measure to assess the impact of urinary incontinence on quality of life with particular reference to social effects.
It consists 20 items sore between 0-10).
19-76 overall score with greater values indicating increased impact on quality of life.
|
6 months
|
Bowel and bladder function
Periodo de tiempo: 9 months
|
We will use the Neurogenic Bowel Dysfunction score.
This valid and reliable questionnaire consist of 10 items.
The minimum score is 0 the maximum score is 47.
The higher the score, the more discomfort.
0-6: very less; Score 7-9: Minimal; Score 10-13: Moderate, Score 14+: severe.
For urinary we use the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol).
The ICIQ-LUTSqol is a psychometrically robust patient-completed questionnaire evaluating quality of life (QoL) in urinary incontinent patients.
The ICIQ-LUTSqol is the King's Health Questionnaire (KHQ) adapted for use within the ICIQ structure and provides a measure to assess the impact of urinary incontinence on quality of life with particular reference to social effects.
It consists 20 items sore between 0-10).
19-76 overall score with greater values indicating increased impact on quality of life.
|
9 months
|
Bowel and bladder function
Periodo de tiempo: 12 months
|
We will use the Neurogenic Bowel Dysfunction score.
This valid and reliable questionnaire consist of 10 items.
The minimum score is 0 the maximum score is 47.
The higher the score, the more discomfort.
0-6: very less; Score 7-9: Minimal; Score 10-13: Moderate, Score 14+: severe.
For urinary we use the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol).
The ICIQ-LUTSqol is a psychometrically robust patient-completed questionnaire evaluating quality of life (QoL) in urinary incontinent patients.
The ICIQ-LUTSqol is the King's Health Questionnaire (KHQ) adapted for use within the ICIQ structure and provides a measure to assess the impact of urinary incontinence on quality of life with particular reference to social effects.
It consists 20 items sore between 0-10).
19-76 overall score with greater values indicating increased impact on quality of life.
|
12 months
|
Bowel and bladder function
Periodo de tiempo: 15 months
|
We will use the Neurogenic Bowel Dysfunction score.
This valid and reliable questionnaire consist of 10 items.
The minimum score is 0 the maximum score is 47.
The higher the score, the more discomfort.
0-6: very less; Score 7-9: Minimal; Score 10-13: Moderate, Score 14+: severe.
For urinary we use the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol).
The ICIQ-LUTSqol is a psychometrically robust patient-completed questionnaire evaluating quality of life (QoL) in urinary incontinent patients.
The ICIQ-LUTSqol is the King's Health Questionnaire (KHQ) adapted for use within the ICIQ structure and provides a measure to assess the impact of urinary incontinence on quality of life with particular reference to social effects.
It consists 20 items sore between 0-10).
19-76 overall score with greater values indicating increased impact on quality of life.
|
15 months
|
Bowel and bladder function
Periodo de tiempo: 18 months
|
We will use the Neurogenic Bowel Dysfunction score.
This valid and reliable questionnaire consist of 10 items.
The minimum score is 0 the maximum score is 47.
The higher the score, the more discomfort.
0-6: very less; Score 7-9: Minimal; Score 10-13: Moderate, Score 14+: severe.
For urinary we use the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol).
The ICIQ-LUTSqol is a psychometrically robust patient-completed questionnaire evaluating quality of life (QoL) in urinary incontinent patients.
The ICIQ-LUTSqol is the King's Health Questionnaire (KHQ) adapted for use within the ICIQ structure and provides a measure to assess the impact of urinary incontinence on quality of life with particular reference to social effects.
It consists 20 items sore between 0-10).
19-76 overall score with greater values indicating increased impact on quality of life.
|
18 months
|
Bowel and bladder function
Periodo de tiempo: 21 months
|
We will use the Neurogenic Bowel Dysfunction score.
This valid and reliable questionnaire consist of 10 items.
The minimum score is 0 the maximum score is 47.
The higher the score, the more discomfort.
0-6: very less; Score 7-9: Minimal; Score 10-13: Moderate, Score 14+: severe.
For urinary we use the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol).
The ICIQ-LUTSqol is a psychometrically robust patient-completed questionnaire evaluating quality of life (QoL) in urinary incontinent patients.
The ICIQ-LUTSqol is the King's Health Questionnaire (KHQ) adapted for use within the ICIQ structure and provides a measure to assess the impact of urinary incontinence on quality of life with particular reference to social effects.
It consists 20 items sore between 0-10).
19-76 overall score with greater values indicating increased impact on quality of life.
|
21 months
|
Bowel and bladder function
Periodo de tiempo: 24 months
|
We will use the Neurogenic Bowel Dysfunction score.
This valid and reliable questionnaire consist of 10 items.
The minimum score is 0 the maximum score is 47.
The higher the score, the more discomfort.
0-6: very less; Score 7-9: Minimal; Score 10-13: Moderate, Score 14+: severe.
For urinary we use the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol).
The ICIQ-LUTSqol is a psychometrically robust patient-completed questionnaire evaluating quality of life (QoL) in urinary incontinent patients.
The ICIQ-LUTSqol is the King's Health Questionnaire (KHQ) adapted for use within the ICIQ structure and provides a measure to assess the impact of urinary incontinence on quality of life with particular reference to social effects.
It consists 20 items sore between 0-10).
19-76 overall score with greater values indicating increased impact on quality of life.
|
24 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Medication
Periodo de tiempo: 3 months
|
Use of medication.
We ask the patient to fill in an digital diary concerning medication intake.
We ask digital information in a format with: Name of the medication, number of intake, prescription or not, regular or extra, reason.
|
3 months
|
Medication
Periodo de tiempo: 6 months
|
Use of medication.
We ask the patient to fill in an digital diary concerning medication intake.
We ask digital information in a format with: Name of the medication, number of intake, prescription or not, regular or extra, reason.
|
6 months
|
Medication
Periodo de tiempo: 9 months
|
Use of medication.
We ask the patient to fill in an digital diary concerning medication intake.
We ask digital information in a format with: Name of the medication, number of intake, prescription or not, regular or extra, reason.
|
9 months
|
Medication
Periodo de tiempo: 12 months
|
use of medication.
We ask the patient to fill in an diary concerning medication.
|
12 months
|
Medication
Periodo de tiempo: 15 months
|
Use of medication.
We ask the patient to fill in an digital diary concerning medication intake.
We ask digital information in a format with: Name of the medication, number of intake, prescription or not, regular or extra, reason.
|
15 months
|
Medication
Periodo de tiempo: 18 months
|
Use of medication.
We ask the patient to fill in an digital diary concerning medication intake.
We ask digital information in a format with: Name of the medication, number of intake, prescription or not, regular or extra, reason.
|
18 months
|
Medication
Periodo de tiempo: 21 months
|
Use of medication.
We ask the patient to fill in an digital diary concerning medication intake.
We ask digital information in a format with: Name of the medication, number of intake, prescription or not, regular or extra, reason.
|
21 months
|
Medication
Periodo de tiempo: 24 months
|
Use of medication.
We ask the patient to fill in an digital diary concerning medication intake.
We ask digital information in a format with: Name of the medication, number of intake, prescription or not, regular or extra, reason.
|
24 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- S58158
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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Ensayos clínicos sobre Observation and follow up measurement
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