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| Name | Class |
|---|---|
| Hospital Asepeyo Barcelona | UNKNOWN |
| Biomechanical Engineering Lab (BIOMEC) - Universitat Politècnica de Catalunya (UPC) | UNKNOWN |
| Institut Nacional d'Educació FÃsica de Catalunya (INEFC) | UNKNOWN |
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This randomized crossover study will compare walking with KAFO type orthoses (current standard of care) versus the ABLE Exoskeleton device, during walking in patients with spinal cord injury in a hospital setting. The ABLE Exoskeleton is a robotic exoskeleton that actively assists individuals with mobility problems to stand up, walk and sit down.
The main objective of the study is to compare the energy efficiency during gait with both devices. Secondary objectives are: compare gait kinematics, usability, user's satisfaction, physical activity and psychosocial impact. The study will also serve to evaluate the usability and safety of the ABLE Exoskeleton in clinical practice.
Subjects will complete 10 gait training sessions during a 5-week period with 1 of the 2 devices randomly selected, followed by a post-training assessment consisting of 1 session. Once the test is completed, subjects will have a 2-week rest period after which they will repeat the process with the other device for 5 weeks (followed by 1 post-training assessment session). The study will be conducted at Hospital Asepeyo Barcelona in Spain, where a total of 10 patients will be recruited.
The primary objective of this study is determining the energy efficiency through gases exchange and kinematic gait analysis to compare the standard of assistance (KAFO type orthoses) and the ABLE Exoskeleton, a robotic gait assistance device, in patients with spinal cord injury (SCI) in a hospital setting.
The secondary objectives are to compare the performance of KAFO-type orthoses with that of the ABLE Exoskeleton device by:
In addition to these objectives, the safety of the ABLE Exoskeleton as an assistive device for gait rehabilitation in SCI patients will be evaluated throughout the study.
Participants will perform 2 training sessions per week of approximately 90 minutes duration for 5 weeks with each of the devices, completing a total of 10 sessions with KAFO type orthoses and 10 sessions with the ABLE Exoskeleton. Before starting the training period, the physical capacity of the participants will be measured. During the training period sessions, different measurements of the level of assistance, spatiotemporal gait variables and usability will be taken. Standardized clinical assessments will also be performed during sessions 5 and 10 (assessment sessions). At the end of the training period, a post-training assessment will be performed, consisting of 1 session where the physical capacity of the participants will be measured. After finishing the training period with one of the devices, participants will have a rest period of 2 weeks, after which they will change devices and repeat the whole process.
The main hypothesis of the study is that gait efficiency in patients with SCI is improved (lower energy consumption) when using the ABLE Exoskeleton device in comparison with KAFO-type orthoses. The increase in gait efficiency encourages patients to stand and walk for longer periods instead of using the wheelchair, which boosts their rehabilitation and improves their health.
Secondary hypotheses are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABLE Exoskeleton - KAFO | Experimental | Participants belonging to this arm start the study by performing the training program using the ABLE Exoskeleton. After the resting period, they repeat the training program using KAFO orthoses. |
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| KAFO - ABLE Exoskeleton | Experimental | Participants belonging to this arm start the study by performing the training program using the KAFO orthoses. After the resting period, they repeat the training program using the ABLE Exoskeleton. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABLE Exoskeleton | Device | Participants will use the ABLE Exoskeleton to perform therapy activities (sit-to-stand transfers, walk, turns, balance exercises, normalized tests). Participants will perform a total of 10 training sessions of an approximate duration of 90 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of gas exchange during 6 Minute Walk Test (6 MWT) | 6 Minute Walk Test (6 MWT) measures the distance a person can walk in 6 minutes. There are different possibilities for performing this test. For this study, we will use a track of at least 10 meters, where patients walk back and forth. | Session #5, Session #10. Sessions take place 2x/week over a 5 week training period. |
| Measurement of gas exchange during the Timed Up and Go Test (TUG) | Timed Up and Go Test (TUG) measures the time it takes a person to get up from a chair, walk 3 meters, turn around and sit down again. It is a widely used test to assess balance and the risk of falls in different patient groups. | Session #5, Session #10. Sessions take place 2x/week over a 5 week training period. |
| Measurement of gas exchange during Graded exercise testing (GXT) | Maximal Graded Exercise Test (GXT) is a screening tool to track an individual's fitness level. The test evaluates the participant's exercise capacity by measuring the cardiovascular response to physical activity. Through this test, the values of maximal oxygen consumption will be obtained and used to obtain metrics to assess energy efficiency during the gait. | Change from preliminary assessment through study completion, an average of 16 weeks. |
| Measurement of gas exchange during 10 Meter Walk Test (10MWT) | The 10 Meter Walk Test (10 MWT) measures the time a person needs to walk 10 meters. The test is performed with a dynamic (flying) start with two-meter acceleration, a timed ten-meter distance and two-meter deceleration. | Session #5, Session #10. Sessions take place 2x/week over a 5 week training period. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of the Level of Assistance to perform therapy activities. | To measure the time required to learn to use the device under investigation, different activities (don/doff, balance, walking, advanced abilities) will be performed during the training period. The difficulty of each activity increases as they are completed. | Up to 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Gait Analysis | Kinematic and kinetic gait parameters will be calculated from data acquired with a motion capture system. | Session #5, Session #10. Sessions take place 2x/week over a 5 week training period. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| LluÃs Guirao Cano, MD PhD | Hospital ASEPEYO Sant Cugat | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Asepeyo Sant Cugat | Sant Cugat del Vallès | Barcelona | 08174 | Spain |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D010264 | Paraplegia |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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Participants will complete 10 gait training sessions during a 5-week period with one of the two devices (ABLE Exoskeleton or KAFO orthoses) followed by a post-training assessment. After the training program with the first device, participants will have 2 weeks resting time, after which they will repeat the process with the other device. The initial device assignment (ABLE Exoskeleton or KAFO) is performed randomly.
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| KAFO Orthosis | Device | Participants will use a pair of KAFO-type passive orthosis to perform therapy activities (sit-to-stand transfers, walk, turns, balance exercises, normalized tests). Participants will perform a total of 10 training sessions of an approximate duration of 90 minutes. |
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| Perceived level of exertion | For measuring impact on the perceived level of exertion, the BORG will be tested after the 6 MWT/TUG/GXT with and without the device. The BORG scale measures the subjective level of intensity in physical work on a 15-grade scale. It ranges from 6 (No exertion at all) to 20 (Maximal exertion). | Up to 6 weeks |
| Fatigue Visual Analog Scale (VAS) | The scale consists of a straight line where one end means the absence of fatigue and the other end means maximal fatigue. The patient selects a point in the line which coincides with their level of fatigue. | Up to 6 weeks |
| Spinal Cord Independence Measure (SCIM) III | Spinal Cord Independence Measure (SCIM III) scale focuses on the ability to perform activities of daily living in persons with SCI. The SCIM III consists of three subscales: Self-Care, Respiratory and Sphincter Management, Mobility (room and toilet) and Mobility (indoors and outdoors, on even surface). A total score of 0 (totally dependent) to 100 (totally independent) points can be achieved. | Up to 10 days before first session and up to 10 days after first session |
| Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) | QUEST 2.0 is designed to measure the level of satisfaction and the value people attribute to assistive technologies. It does so using 12 variables which are scored on a 5 point scale in terms of perceived importance and satisfaction. While items 1-8 rate the satisfaction with the device, items 9-12 are for assessing the satisfaction with the service. If the users are not very satisfied with a feature, they are asked to provide specific feedback. The final score is the mean sum scores of all valid responses with a range of 1 (not satisfied at all) to 5 (very satisfied). | Up to 6 weeks |
| Psychosocial Impact of Assistive Devices Scales (PIADS) | PIADS is a 26-item (7-point Likert-Scale), self-report questionnaire designed to assess the effects of an assistive device on functional independence, well-being, and quality of life. It is divided into three subscales: Competence, adaptability and self-esteem. For each of the subscales, typically means are calculated that range from -3 (maximum negative impact) to +3 (maximum positive impact). To have only positive sum scores, the range of the individual scores are shifted to 1 to 7, meaning that the sum scores range from 1 *26 (26, maximum negative impact) to 7 *26 (182, maximum positive impact). The PIADS is a responsive measure and sensitive to important variables such as the user's clinical condition, device stigma, and functional features of the device. It has been shown to accurately reflect the self-described experiences of people who use assistive devices. | Up to 6 weeks and followup (4 weeks after study completion). |
| D014947 | Wounds and Injuries |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |