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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-24-10-049336 | Other Identifier | AEMPS |
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| Name | Class |
|---|---|
| Fundación Esclerosis Múltiple Madrid (FEMM) | UNKNOWN |
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The goal of this study is to explore the potential clinical benefits of the ABLE Exoskeleton as part of a rehabilitation program in people with multiple sclerosis. The main question it aims to answer is:
Can a rehabiliation program with the ABLE Exoskeleton help to mantain the physical and psychosocial health of people with multiple sclerosis?
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention with exoskeleton | Experimental | Participants will undergo 60-min gait training sessions with the exoskeleton as part of their rehabilitation program once a week for up to 12 months |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABLE Exoskeleton | Device | Participants will undergo 60-min gait training sessions with the exoskeleton once a week for up to12 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of therapeutic objectives achieved | Two therapeutic objectives per participant will be defined at baseline. At the end of the training program, it will be assessed if the objectives were accomplished or not. | From baseline to the end of the training program at 12 months |
| Lower extremity muscle strenght | The Daniels Muscle Testing scale will be used to measure the strength of muscles in the lower extremities at baseline, every 3 months and at the end of the gait training program to assess motor function after the training. Scores range from 0 (absence of muscle activity) to 5 (normal muscle activity) | Baseline, 3, 6, and 12 months post-training |
| Modified Ashworth Scale (MAS) | The Modified Ashworth Scale (MAS) measures spasticity in patients with lesions to the central nervous system. The scale assigns a grade of spasticity from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension). It will be evaluated at baseline, every 3 months and at the end of the gait training program without the device to assess the change in the spasticity after training | Baseline, 3, 6, and 12 months post-training |
| Location and level of pain | The location and level of pain using the numeric rating scale (NRS) will be assessed at baseline, every 3 months and at the end of the gait training program to assess the reduction of pain aftr the training | Baseline, 3, 6, and 12 months post-training |
| Timed 25-Feet Walk test (T25FW) | The Timed 25-Foot Walk (T25FW) test measures the time a person needs to walk 25 feet. This test will be assessed at baseline, every 3 months, and at the end of the gait training program without the device to assess the change in the walking function after the training |
| Measure | Description | Time Frame |
|---|---|---|
| Time spent upright and time spent walking | In each gait training session, the time spent upright (in minutes) and the time spent walking (in minutes) with the device will be automatically measured and registered by the device | At session 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 |
| Number of steps walked |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundación Esclerosis Múltiple Madrid (FEMM) | Madrid | Madrid | 28029 | Spain |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Baseline, 3, 6, and 12 months post-training |
| 6-Minute Walk Test (6MWT) | The 6-Minute Walk Test (6MWT) measures the distance a person can walk in 6 minutes. This test will be assessed at baseline, every 3 months, and at the end of the gait training program without the device to assess the change in the walking function after the training | Baseline, 3, 6, and 12 months post-training |
| Borg Rating of Perceived Exertion | The Borg Rating of Perceived Exertion (RPE) scale is used to measure a person's perception of their effort and exertion, breathlessness, and fatigue during physical activity. Scores range from 6 (no exertion at all) to 20 (maximal exertion). It will be evaluated during the 6MWT at baseline, every 3 months, and after the end of the gait training program without the device to assess the change in the perceived exertion after the training | Baseline, 3, 6, and 12 months post-training |
| Trunk Impairment Scale (TIS) | The Trunk Impairment Scale (TIS) measures the motor impairment of the trunk through the evaluation of static and dynamic sitting balance as well as coordination of trunk movement. The total score ranges from 0 (minimal performance) to 23 (perfect performance). This test will be assessed at baseline, every 3 months, and at the end of the gait training program without the device to assess the change in the trunk impairment after training | Baseline, 3, 6, and 12 months post-training |
| Barthel Index (BI) score | The Barthel Index (BI) will be used to assess the participants' ability to perform mobility and self-care activities of daily living (ADL). The total score ranges from 0 (total dependency) to 100 (independency). It will be evaluated at baseline, every 3 months, and after the gait training program without the device to assess the change in the independence to perform ADL after the training | Baseline, 3, 6, and 12 months post-training |
| Modified Fatigue Impact Scale (MFIS) score | The Modified Fatigue Impact Scale (MFIS) provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning in persons with multiple sclerosis. The total score ranges from 0 to 84, with higher scores meaning a higher impact of fatigue. It will be evaluated iat baseline, every 3 months and at the end of the gait training program without the device to assess the change in the fatigue after the training | Baseline, 3, 6, and 12 months post-training |
| Multiple Sclerosis Quality of Life-54 (MSQoL-54) scores | The Multiple Sclerosis Quality of Life-54 (MSQoL-54) is a multidimensional health-related quality of life (QoL) measure that combines both generic and MS-specific items into a single instrument. There is no single overall score for the MSQoL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores. The higher the score, the best the outcome. It will be evaluated at baseline, every 3 months and at the end of the gait training program without the device to assess the change in the QoL after the training | Baseline, 3, 6, and 12 months post-training |
| Self-perceived impact on general health status | Participants' perceptions of the impact on their general health will be evaluated by the completion of a self-report questionnaire on the perceived impact on general health. This questionnaire has been designed by the researchers and intends to identify to what extent participants feel that the ABLE Exoskeleton contributed to a change in their health. The questionnaire covers 7 categories (cardiovascular system, musculoskeletal pain, neuropathic pain, bladder and bowel, spasticity, and sleep quality) using a 7-point Likert scale to assess the change. | 3, 6, and 12 months post-training |
| Level of motivation | Participants' perceptions on the level of motivation generated by the program with the ABLE Exoskeleton will be evaluated by the completion of a self-report questionnaire using a 7-point Likert scale. This questionnaire has been designed by the researchers. | After 12 months post-training |
| Psychosocial Impact of Assistive Devices Scale (PIADS) score | The Psychosocial Impact of Assistive Devices Scale (PIADS) is a 26-item, self-reported questionnaire that provides a measure of user perception and other psychological factors associated with assistive technology devices. Scores range from -78 (maximum negative impact) to +78 (maximum positive impact). It will be used to assess the effects of the ABLE Exoskeleton on functional independence, well-being, and quality of life of participants after the training program experience | After 12 months post-training |
| Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) score | The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) is a 12-item outcome measure that assesses user satisfaction with two components (Device and Services) using a 5-point scale ranging from 1 (not satisfied) to 5 (very satisfied). Only the 8 items referred to the device will be evaluated from participants and the whole 12 items from the therapists to measure user satisfaction with the ABLE Exoskeleton after the training program experience | After 12 months post-training |
In each gait training session, the number of steps taken (step count) with the device will be automatically measured and registered by the device |
| At session 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 |
| Distance walked | In each gait training session, the distance walked (in meters) with the device will be automatically measured and registered by the device | At session 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |