- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní místa
-
-
Antwerp
-
Geel, Antwerp, Belgie, 2440
- Nábor
- De Maesschalck Lieven
-
Kontakt:
- Lieven De Maesschalck
- Telefonní číslo: 0479911974
- E-mail: lieven.demaesschalck@thomasmore.be
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- SCI
- Bone density
Exclusion Criteria:
- osteoporosis
- length more than 2 meter
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
---|---|
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:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
ROM (Range of Motion)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Medication
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 12 months
|
use of medication.
We ask the patient to fill in an diary concerning medication.
|
12 months
|
Medication
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- S58158
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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