Robot Assisted Gait Training in Persons With a Spinal Cord Injury
30 mei 2022 bijgewerkt door: Lieven De Maesschalck, Thomas More Kempen
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.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Verwacht)
15
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Antwerp
-
Geel, Antwerp, België, 2440
- Werving
- De Maesschalck Lieven
-
Contact:
- Lieven De Maesschalck
- Telefoonnummer: 0479911974
- E-mail: lieven.demaesschalck@thomasmore.be
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 70 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
Approximately 50 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
Beschrijving
Inclusion Criteria:
- SCI
- Bone density
Exclusion Criteria:
- osteoporosis
- length more than 2 meter
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
ROM (Range of Motion)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Medication
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 12 months
|
use of medication.
We ask the patient to fill in an diary concerning medication.
|
12 months
|
|
Medication
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
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Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 februari 2012
Primaire voltooiing (Werkelijk)
30 oktober 2014
Studie voltooiing (Verwacht)
31 december 2022
Studieregistratiedata
Eerst ingediend
18 mei 2022
Eerst ingediend dat voldeed aan de QC-criteria
30 mei 2022
Eerst geplaatst (Werkelijk)
2 juni 2022
Updates van studierecords
Laatste update geplaatst (Werkelijk)
2 juni 2022
Laatste update ingediend die voldeed aan QC-criteria
30 mei 2022
Laatst geverifieerd
1 mei 2022
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- S58158
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Ja
product vervaardigd in en geëxporteerd uit de V.S.
Ja
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .