Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05401734
Other study ID # S58158
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2012
Est. completion date December 31, 2022

Study information

Verified date May 2022
Source Thomas More Kempen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date December 31, 2022
Est. primary completion date October 30, 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - SCI - Bone density Exclusion Criteria: - osteoporosis - length more than 2 meter

Study Design


Intervention

Device:
Observation and follow up measurement
The measured variables include: Questionnaires Health related quality of life (Health Related Quality of Life Questionnaire) Physical activity level (Physical Activity Scale for Persons with Impairments and Disabilities) Walking ability (Walking Index for Spinal Cord Injury) Independence in activities of daily living (SCIM III Questionnaire) Pain (International SCI Pain Basic Data Set) Resilience (Resilience Scale) Bowel and bladder function (Neurogenic Bowel Dysfunction score, International Consultation on Incontinence Modular Questionnaire - Lower Urinary Tract Symptoms) Measurements: Muscular strength and joint ROM (Manual Muscle Testing) Spasticity (Modified Ashworth Scale) Walking parameters (walking time, crutch position, forward and lateral center of gravity shift, step length and height, swing phase, walking speed) Cardiovascular response (blood pressure, heart frequency, blood lactate concentration and Borg RPE score)

Locations

Country Name City State
Belgium De Maesschalck Lieven Geel Antwerp

Sponsors (2)

Lead Sponsor Collaborator
Thomas More Kempen AZ Herentals

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary ROM (Range of Motion) 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
Primary ROM (Range of Motion) 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
Primary ROM (Range of Motion) 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
Primary ROM (Range of Motion) 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
Primary ROM (Range of Motion) 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
Primary ROM (Range of Motion) 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
Primary ROM (Range of Motion) 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
Primary ROM (Range of Motion) 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
Primary WHOQOL 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
Primary WHOQOL 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
Primary WHOQOL 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
Primary WHOQOL 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
Primary WHOQOL 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
Primary WHOQOL 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
Primary WHOQOL 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
Primary WHOQOL 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
Primary IPA 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
Primary IPA 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
Primary IPA 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
Primary IPA 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
Primary IPA 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
Primary IPA 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
Primary IPA 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
Primary IPA 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
Primary Bowel and bladder function 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
Primary Bowel and bladder function 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
Primary Bowel and bladder function 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
Primary Bowel and bladder function 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
Primary Bowel and bladder function 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
Primary Bowel and bladder function 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
Primary Bowel and bladder function 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
Primary Bowel and bladder function 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
Secondary Medication 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
Secondary Medication 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
Secondary Medication 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
Secondary Medication use of medication. We ask the patient to fill in an diary concerning medication. 12 months
Secondary Medication 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
Secondary Medication 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
Secondary Medication 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
Secondary Medication 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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05630235 - Effects of Cannabidiol (CBD) on Resting-state Electroencephalography (EEG) and Neuropathic Pain Severity in People With Spinal Cord Injury (SCI) Phase 1/Phase 2
Completed NCT04855812 - The Efficacy of Upper Extremity Wearable Robotic Orthosis on Improving Upper Extremity Motor Function and Activities of Daily Living in Persons With Spinal Cord Injury N/A
Recruiting NCT06349434 - The Utilization Effects of Powered Wearable Orthotics in Improving Upper Extremity Function and ADL in Persons With SCI N/A
Completed NCT03352505 - Cardiovascular Risk Markers in Spinal Cord Injured Subjects of the Wheelchair Dancer Study
Recruiting NCT03698149 - ECoG BMI for Motor and Speech Control N/A
Not yet recruiting NCT03052244 - tDCS and VI to Treat Neuropathic Pain and Function in SCI N/A
Recruiting NCT05705453 - Epidural Stimulation After Neurologic Damage: Long-Term Outcomes N/A
Recruiting NCT05638191 - Nerve Transfer Surgery to Restore Upper-limb Function After Cervical Spinal Cord Injury
Completed NCT03175055 - Phoenix Exoskeleton for SCI Users N/A
Completed NCT05945784 - Exploring Accessible Beauty for Individuals With Upper Extremity Deficits
Withdrawn NCT04506099 - Transcutaneous Intercostal Nerve Stimulation in Spinal Cord Injury N/A
Enrolling by invitation NCT03225625 - Stem Cell Spinal Cord Injury Exoskeleton and Virtual Reality Treatment Study N/A
Recruiting NCT06000592 - Safety, Feasibility, and Efficacy of TSCS on Stabilizing Blood Pressure for Acute Inpatients With SCI N/A
Completed NCT05022095 - "Validated Language Transfer of the Spinal Cord Injury-Spasticity Evaluation Tool to German Language"
Recruiting NCT05386537 - Combining Wearable Robotic Orthosis With Visual and Haptic Feedback to Enhance the Recovery of Upper Extremity Motor Function and ADL in Persons With Acute SCI Early Phase 1
Active, not recruiting NCT03702842 - Stimulation to Enhance Walking Post-SCI N/A