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| Name | Class |
|---|---|
| Università Campus Bio-Medico di Roma (UCBM) | UNKNOWN |
| Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna | OTHER |
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People affected by stroke or brachial plexus injuries experience huge impairment in using upper limbs for everyday life activities. Brachial plexus is responsible of sensory-motor innervation of the whole upper limb, the shoulder and also a part of the chest. The majority of such injuries is caused by traumatic events that involve young and healty people in most cases and motor impairment varies together with either the type (complete or incomplete) or the site of injury. It follows the need to realize devices capable of restoring people everyday life independence.
To assist these patients, the most common solutions are passive ortheses that give support to shoulder and forearm without actively enhancing limb functionalities. MyoPro (by MIT, Myomo1) is the only active device available for elbow and wrist, even not completely proven for everyday life yet. It comes from scientific evidences that gravity compensation and functional electrical stimulation (FES) are considerable techniques for rehabilitation of brachial plexus injuries and post-stroke patients. According to the most recent results, hybrid systems that combine FES with robotic joints seem to give interesting benefits in such the contexts taken into account.
The goal of this clinical trial is to assess feasibility, functionality and usability of a new assistive, hybrid, active and portable orthesis for upper limb aimed at improving motor functionality of brachial plexus injuries patients. Complying with weight and size requirements, the device under investigation is designed to assist the whole upper limb with its two modules: a robotic exoskeleton to actively give assistance to shoulder and elbow and a FES module to assist wrist and hand.
The main points the clinical trial aims to address concern:
Post-stroke and brachial plexus injuries patients (with Medical Research Council Scale for Muscle Strength equal to or more than 2) will be enrolled and asked to perform the following tasks with and without wearing the device:
Study procedure consists of 6 session outlined as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recruited subjects with exoskeleton | Experimental | Subjects are asked to perform the study procedure while wearing the assistive device |
|
| Recruited subjects without exoskeleton | No Intervention | Subjects are asked to perform the study procedure not wearing the assistive device |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assistive exoskeleton for activities of daily living (ADLs) | Device | Portable assistive exoskeleton to support upper limb movement during activities of daily living |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events occurred during use of the exoskeleton | Number of device failures and malfunctioning, device-related harms during device use | During the intervention at days 2, 3, 4, 5 |
| Change of score in Box and Blocks Test | The box and block test measures how many cubic wooden blocks the subject is able to move from one side of a wooden box to the other side in 60 seconds. The subject is asked to perform the Box And Blocks test while wearing the device and without the device for comparison. | During the intervention at days 3, 4, 5 |
| Change in performance during the execution of activities of daily living (ADLs) | The subject is asked to perform different ADLs while wearing the device and without the device. Time for the execution and successful rate of activities are registered for comparison. | During the intervention at days 3, 4, 5 |
| Change in kinematics during execution of tasks | The subject is asked to perform the box and block test, maximum reaching height task and activites of daily living while wearing the device in assitive mode and without the device. The experimental setup is provided with Magneto-Inertial Measurement Unit (M-IMU) sensors capable to measure speed and smoothness of movements in both cases for comparison. | During the intervention at days 3, 4, 5 |
| Change in upper limbs muscles activation during execution of tasks | The subject is asked to perform the box and block test, maximum reaching height task and activites of daily living while wearing the device in assitive mode and without the device. The experimental setup is provided with surface EMG sensors capable to measure upper limb muscles activation in both cases for comparison. |
| Measure | Description | Time Frame |
|---|---|---|
| System Usability Scale (SUS) | SUS is a questionnaire aiming at measuring the perceived usability of the device. It's a 10-item questionnaire, 5-points Likert scale with item score ranging from 1 (strongly disagree) to 5 (strongly agree). In SUS score calculation, each item's score contribution will range from 0 to 4 with the final score obtained by summing the score contributions from each item and multiplying it by 2.5, in order to have a value in the range of 0 to 100. The higer the final score, the better the outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emanuele Gruppioni, PhD | Contact | +39 051 6936 609 | e.gruppioni@inail.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Protesi Inail | Recruiting | Budrio | Bologna | 40054 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | A. M. Stewart, C. G. Pretty, M. Adams, and X. Chen, "Review of Upper Limb Hybrid Exoskeletons," IFAC-Pap., vol. 50, no. 1, pp. 15169-15178, Jul. 2017, doi: 10.1016/j.ifacol.2017.08.2266. | ||
| Background | M. F. Penna et al., "Design and Administration of a Questionnaire for the User-Centered Design of a Novel Upper-Limb Assistive Device for Brachial Plexus Injury and Post-stroke Subjects," in Computers Helping People with Special Needs, K. Miesenberger, G. Kouroupetroglou, K. Mavrou, R. Manduchi, M. Covarrubias Rodriguez, and P. Penáz, Eds., in Lecture Notes in Computer Science. Cham: Springer International Publishing, 2022, pp. 420-427. doi: 10.1007/978-3-031-08645-8_49. | ||
| 22151384 | Background | Popovic MR, Thrasher TA, Zivanovic V, Takaki J, Hajek V. Neuroprosthesis for retraining reaching and grasping functions in severe hemiplegic patients. Neuromodulation. 2005 Jan;8(1):58-72. doi: 10.1111/j.1094-7159.2005.05221.x. | |
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Demographic and clinical data collected during the trial will be anonymized and aggregated prior to sharing
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Within one year after trial conclusion (december 2025)
Anonymized not aggregated data could be available upon request
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| Assistive exoskeleton for box and block | Device | Portable assistive exoskeleton to support box and block test execution |
|
| Assistive exoskeleton for maximum reaching height | Device | Portable assistive exoskeleton to raise the upper limb at the maximum of its capability to reach objects at different heights |
|
| During the intervention at days 3, 4, 5 |
| During the intervention at days 3, 4, 5 |
| Quebec User Evaluation of Satisfaction with assistive Technology questionnaire (QUEST) | QUEST is a questionnaire aiming at measuring the perceived satisfaction of the device after use. It's a 12-item questionnaire, with item score ranging from 1 (worst) to 5 (best). The final score is obtained as an average of the items scores. The higer the final score, the better the outcome. | During the intervention at days 3, 4, 5 |
| Numeric Rating Scale (NRS) for satisfaction | A custom NRS 0-10 is created to measure the perceived level of acceptance of the device after use. The subject is asked to evaluate its perception of weight, comfort, safety and assistance wearing the device, with item score ranging from 0 (best) to 10 (worst). The higher the scores, the worse the outcome. | During the intervention at days 3, 4, 5 |
| Numeric Rating Scale (NRS) for pain evaluation | The subject is asked to evaluate its level of musculoskeletal pain after use with a score ranging from 0 (no pain) to 10 (max pain). The higher the score, the worse the outcome. | During the intervention at days 3, 4, 5 |
| NASA Task Load Index (NASA-TLX) | NASA-TLX is used with the aim of measuring the effectiveness of the device after use. It is a multi-dimensional rating procedure that provides an overall workload score based on a weighted average of ratings on six subscales: Mental Demands, Physical Demands, Temporal Demands, Own Performance, Effort, and Frustration. For each task or group of tasks, the subject is asked to select an option for each of the 15 comparison cards given (to obtain weights) and to express a score ranging from 1 (low/good) to 20 (high/poor) for each subscale (rate). The final workload score is computed by multiplying each rating by the weight given to that factor by that subject, then the sum of the weighted ratings for each task is divided by 15. The higer the final score, the worse the outcome. | During the intervention at days 3, 4, 5 |
| Flow State Scale (FSS) | FSS is a questionnaire aiming at measuring the user experience of the device during use. It's a 36-item questionnaire, with item score ranging from 1 (strongly disagree) to 5 (strongly agree). As 5-point Likert scale with 4 items per 9 subscales, the item scores for each dimension are summed and then divided by four, to obtain flow dimension item-average scores. The higer the final score, the better the outcome. | During the intervention at days 3, 4, 5 |
| Category-Ratio 0-10 scale (Borg CR-10) | Borg CR-10 Scale is a subjective measure of perceived exertion or intensity during the execution of tasks. Body sensations under evaluation concern heart rate, breath rate and muscle fatigue with item score ranging from 0 (nothing at all) to 10 (maximum). The higher the single scores, the worse the outcome. | During the intervention at days 3, 4, 5 |
| 27692878 |
| Background |
| Resquin F, Cuesta Gomez A, Gonzalez-Vargas J, Brunetti F, Torricelli D, Molina Rueda F, Cano de la Cuerda R, Miangolarra JC, Pons JL. Hybrid robotic systems for upper limb rehabilitation after stroke: A review. Med Eng Phys. 2016 Nov;38(11):1279-1288. doi: 10.1016/j.medengphy.2016.09.001. Epub 2016 Sep 29. |
| 15452843 | Background | Ferrante MA. Brachial plexopathies: classification, causes, and consequences. Muscle Nerve. 2004 Nov;30(5):547-68. doi: 10.1002/mus.20131. |
| ID | Term |
|---|---|
| D000203 | Activities of Daily Living |
| D003766 | Dental Occlusion |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003813 | Dentistry |
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
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