Robot Assisted Gait Training in Persons With a Spinal Cord Injury
2022년 5월 30일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
관찰
등록 (예상)
15
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Antwerp
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Geel, Antwerp, 벨기에, 2440
- 모병
- De Maesschalck Lieven
-
연락하다:
- Lieven De Maesschalck
- 전화번호: 0479911974
- 이메일: lieven.demaesschalck@thomasmore.be
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
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
설명
Inclusion Criteria:
- SCI
- Bone density
Exclusion Criteria:
- osteoporosis
- length more than 2 meter
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
ROM (Range of Motion)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Medication
기간: 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
기간: 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
기간: 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
기간: 12 months
|
use of medication.
We ask the patient to fill in an diary concerning medication.
|
12 months
|
|
Medication
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2012년 2월 1일
기본 완료 (실제)
2014년 10월 30일
연구 완료 (예상)
2022년 12월 31일
연구 등록 날짜
최초 제출
2022년 5월 18일
QC 기준을 충족하는 최초 제출
2022년 5월 30일
처음 게시됨 (실제)
2022년 6월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 6월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 5월 30일
마지막으로 확인됨
2022년 5월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .