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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-25-01-050614 | Other Identifier | CCMO |
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| Name | Class |
|---|---|
| Sint Maartenskliniek | OTHER |
| Universitat Politècnica de Catalunya | OTHER |
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The goal of this clinical trial is to to confirm the safety and performance of the ABLE Daily to perform ambulatory functions in home and community settings for people with spinal cord injury.
The experimental period will cover the training period with the ABLE Daily exoskeleton (3 weeks of use at the investigational site with a total of 9 sessions) and the home period (12 weeks of personal use at home and community environments).
The ABLE Daily Exoskeleton is a wearable powered lower-limb exoskeleton that actively assists individuals with spinal cord injury to stand up, walk, ascend and descend a ramp of 5 degrees and sit down. The device consists of a rigid brace that attaches to the torso, legs and feet of the user via straps and supports. It is a bilateral robotic exoskeleton with four battery-powered motors that drive the knee and hip joints assisting in flexion-extension. The other degrees of freedom of the hip and knee joints are restricted. The ankle joint of the exoskeleton is passively articulated with a spring within a limited range of motion.
The experimental period will cover the training period happening at the investigational site where the participants and their companions will be trained 3 times a week. They will then have to perform a community skills test, if passed they will be allowed to take the exoskeleton home and use it in their daily life for 12 weeks. Pre and post assessments will be made.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention with exoskeleton | Experimental | The participants will receive training sessions with the ABLE Daily at Sint Maartenskliniek. After they pass the skills and knowledge exam, they will receive the ABLE Daily at their disposal at home for twelve weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABLE Daily | Device | The participants will receive training sessions with the ABLE Daily at Sint Maartenskliniek. After they pass the skills and knowledge exam, they will receive the ABLE Daily at their disposal at home for twelve weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the device | The total number of adverse events and serious adverse events related to the investigational device at the end of the study will be measured. | Through study completion (up to 16 weeks) |
| Performance of the device during the training period | The number and type of device errors or use errors during the training period. | Through the training period (up to 3 weeks) from training session 1-9 |
| Performance of the device in the home/community period | The amount of use of the device during the home/community use period, as measured by the number of sessions and the walking time, number of steps, and distance walked per session. | Through the home/community period (up to 12 weeks) |
| Performance of the device in the home/community period | The usability of the device as measured by the purpose and location of use of the device during the home/community use period which will be registered in a logbook by the participant. | Through the home/community period (up to 12 weeks) |
| Performance of the device in the home/community period | The number and type of device errors at the end of the home/community use period will be registered. | Through the home/community period (up to 12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived health status | The change from baseline to final assessment of the overall perceived health status of the participants, as measured by the scores of the 36-Item Short Form Survey Instrument (SF-36). Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to high Quality of Life. Lower scores indicate more disability, while higher scores indicate less disability. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular health | Blood draw test to check levels of high-density lipoprotein cholesterol (HDL-c), Low-Density Lipoprotein Cholesterol (LDL-c), Triglyceride (TG), and Total Cholesterol (TC). Improvement is indicated with lower values of LDL-c and lower Triglycerides | Baseline assessment and at the final assessment at the end of the study (16 weeks) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Noel Keijsers | Contact | + 31 6 44244217 | n.keijsers@maartenskliniek.nl | |
| Daphne Oosterling | Contact | d.oosterling@maartenskliniek.nl |
| Name | Affiliation | Role |
|---|---|---|
| Noel Keijsers | Sint Maartenskliniek | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sint Maartenskliniek | Recruiting | Hengstdal | Ubbergen | 6574NA | Netherlands |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| At baseline and the final assessment at end of the study (16 weeks) |
| Gait performance while using the device (6MWT) | The change from the Community Skills Test to the final exoskeleton assessment of the 6-Minute Walk Test (6MWT). The outcome will be the distance walked during the 6 minutes after the training period and once again after the home period. | After training period (3 weeks) and at the final assessment at the end of the study (16 weeks) |
| User satisfaction | The general user satisfaction of participants, companions, and therapists at the end of the study, as measured by the scores of the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0). 12 item instrument used to assess satisfaction with a specific assistive device; eight of these items assess characteristics of that assistive device and the remaining four items assess service and include:
| At the final assessment at the end of the study (16 weeks) |
| Gait performance using the device: 10-Meter Walk Test (10MWT) | The 10 meter walk test will be used to compare performance after the training period and once again after the home period to monitor any changes in speed. | After training period (3 weeks) and at the final assessment at the end of the study (16 weeks) |
| Respiratory Parameters | Spirometry to assess the force vital capacity (FVC). FVC is crucial for evaluating lung function and respiratory and global health. Improvement indicates higher values of FVC. | Baseline assessment, during the 6 minute walk test and at the final assessment at the end of the study (16 weeks) |
| Spasticity | Visual analog scale (VAS) is a self-report tool that allows individuals to rate their perceived level of spasticity on a continuous scale, typically ranging from 0 to 10, where higher scores indicate greater severity. Spasticity is a complex phenomenon that can vary greatly in intensity and impact from person to person. The VAS provides a means for individuals to subjectively quantify and communicate their experience of spasticity, capturing nuances that may not be fully captured by objective measures alone. 0 indicated no spasticity and 10 indicates the most spasticity experienced. | Baseline assessment, end of training period (3 weeks), final assessment at the end of the study (16 weeks) |
| Bowel and bladder management (SCI-QOL) | Bladder Management Difficulties and Bowel Management Difficulties items from the Spinal Cord Injury - Quality of Life (SCI-QOL) questionnaire. The SCI-QOL questionnaire is a validated measure specifically designed to assess the quality of life in individuals with SCI across various domains, including bladder and bowel function | Baseline assessment and at the final assessment at the end of the study (16 weeks) |
| Body composition using BMI | Body weight provides valuable information about body composition. Body Mass Index (BMI) is a simple and straightforward measure calculated using an individual's weight and height. BMI provides a numerical value that categorizes individuals into different weight status categories, such as underweight, normal weight, overweight, or obese. | Baseline assessment and at the final assessment at the end of the study (16 weeks) |
| Insulin Sensitivity | Blood draw test to obtain the homeostatic model assessment (HOMA-IR), an indirect method to quantify insulin resistance and pancreatic β-cell function. HOMA-IR is a mathematical model used to estimate insulin resistance based on fasting glucose and insulin levels. Higher values indicate higher insulin resistance therefore an improvement would be a lower value. | Baseline assessment and at the final assessment at the end of the study (16 weeks) |
| Sleep | The 8-item PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep-Related Impairment questionnaire to measure alertness, sleepiness, tiredness, and functional impairments associated with sleep problems during waking hours. It assesses sleep disturbance over the past seven days. PROMIS instruments are scored using item-level calibrations on a 5 point likert scale from not at all to very much. Higher T-scores indicate greater sleep disturbance. | Baseline assessment and at the final assessment at the end of the study (16 weeks) |
| Body Composition: Waist circumference | Waist circumference measures the circumference of the waist at a specific point, typically at the level of the natural waist or the midpoint between the lower rib and the iliac crest. Lower values indicate better health. | Baseline assessment and at the final assessment at the end of the study (16 weeks) |
| Respiratory Parameters | Spirometry to assess the forced expiratory volume in 1 second (FEV1). FEV1 is crucial for evaluating lung function and respiratory and global health. A higher value indicates better respiratory function | Baseline assessment, during the 6 minute walk test and at the final assessment at the end of the study (16 weeks) |
| Respiratory Parameters | Spirometry to assess the forced expiratory flow (FEF). FEF is crucial for evaluating lung function and respiratory and global health. A higher value indicates better respiratory function. | Baseline assessment, during the 6 minute walk test and at the final assessment at the end of the study (16 weeks) |
| Respiratory Parameters | Spirometry to assess the peak expiratory flow (PEF). PEF is crucial for evaluating lung function and respiratory and global health. A higher value | Baseline assessment, during the 6 minute walk test and at the final assessment at the end of the study (16 weeks) |
| Respiratory Parameters | Spirometry to assess the maximal voluntary ventilation (MVV). MVV is crucial for evaluating lung function and respiratory and global health. A higher value would indicate better lung function. | Baseline assessment, during the 6 minute walk test and at the final assessment at the end of the study (16 weeks) |
| Bowel and bladder management (BSS) | The Bristol Stool Scale categorizes stool consistency into seven distinct types, ranging from hard lumps (Type 1) to watery diarrhea (Type 7), based on visual descriptions and illustrations. The BSS provides a standardized and objective method for individuals to describe their stool consistency, facilitating communication with healthcare providers. | Baseline assessment and at the final assessment at the end of the study (16 weeks) |
| D014947 | Wounds and Injuries |