- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03951844
Wearability, Saefty and Usability Assessment for the Upper Limb Exoskeleton BRIDGE/EMPATIA
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
LC
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Bosisio Parini, LC, Italy, 23842
- IRCCS E. Medea - La Nostra Famiglia
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Costa Masnaga, LC, Italy, 23845
- Villa Beretta
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Availability of the patient and/or caregiver at the signing of the informed consent for participation in a clinical trial study protocol
- Defined diagnosis of Muscular Dystrophy (Duchenne, Becker, Cingoli type 2 and facio-scapulo-humeral). Biopsy will not be performed except in cases where a diagnostic need arises.
- Wheelchair bounded
- Significant weakness in the muscular districts of the shoulder girdle and the proximal upper limb portion detected by the MRC scale (between 0 and 2)
- Cognitive skills that allow the understanding and management of the device
- Arm length measured from the shoulder to the elbow between 26.5 cm and 28.7 cm; forearm length, measured between elbow and wrist, maximum 22.4 cm
Exclusion criteria:
- Presence of important comorbidities (epilepsy, dependence 24/24 hours from non-invasive and invasive ventilation)
- Behavioral and psychiatric disorders (e.g., emotional problems, depression)
- Inability to maintain a sitting position in a wheelchair
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group
Each participant is evaluated while wearing or not wearing the device.
|
The participant wears the exoskeleton on his/her left arm, and he/she controls it by means of a joystick or vocal commands.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Performance of Upper Limbs scale (PUL)
Time Frame: Change from baseline PUL without the exoskeleton and PUL wearing the exoskeleton within 15 days.
|
The PUL includes 22 items with an entry item to define the starting functional level and 21 items subdivided into shoulder level (4 items), middle level (9 items) and distal level (8 items). For weaker patients, a low score on the entry item means high-level items do not need to be performed. Each dimension can be scored separately with a maximum score of 16 for the shoulder level, 34 for the middle level and 24 for the distal level. A total score can be achieved by adding the three level scores, with a maximum global score of 74. The lower the score, the higher the disability. Pane et al., Reliability of the Performance of Upper Limb assessment in Duchenne muscular dystrophy, Neuromuscular disorders 2014, 24:201-206. |
Change from baseline PUL without the exoskeleton and PUL wearing the exoskeleton within 15 days.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ABILHAND
Time Frame: Change from baseline PUL without the exoskeleton and PUL wearing the exoskeleton within 15 days.
|
Self-administered questionnaire aimed at measuring manual ability in daily life. Patients are asked to answer 14 questions plus 4 items differentiated with respect to the age of participant (older or younger than 15 years). Overall, the Abilhand questionnaire has 22 items. For each item, the participant has to answer if the presented action is "impossible", "difficult" or "easy" to be performed in his/her opinion. A three-level scale is used to calculate a total score according to the answer given: "impossible" (0 points), "difficult" (1 point) and "easy" (2 points). The higher the score, the easier the perception of self-ability. Data are converted to a probabilistic model through the Rasch model, which estimates the item difficulty and a patient's manual ability on a standard linear scale, within a probabilistic framework. Penta et al., ABILHAND: a Rasch-built measure of manual ability, Archives of Physical Medicine and Rehabilitation 1998, 79:1038-1042. |
Change from baseline PUL without the exoskeleton and PUL wearing the exoskeleton within 15 days.
|
Technology acceptance model (TAM) questionnaire
Time Frame: Within 15 days from the baseline
|
The technology acceptance model (TAM) is an information systems theory that models how users come to accept and use a technology.
A dedicated TAM has been developed, and administered to the patients in the form of 26 questions on the evaluation of different aspects of the device (e.g., saefty, confort, etc.).
For each item, the patient has to provide a score from 1 to 5, where 1 is completely disagree and 5 is completely agree.
The higher the score, the better the technology acceptance.
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Within 15 days from the baseline
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System usability scale (SUS)
Time Frame: Within 15 days from the baseline
|
It is a ten-items scale giving a global view of subjective assessments of usefulness as a combination of effectiveness, efficiency, and satisfaction. Each item score contribution ranged from 1 to 5. For items 1, 3, 5, 7 and 9 (the positively worded items) the score contribution was the scale position given by the subject minus 1. For items 2, 4, 6, 8 and 10 (the negatively worded items), the contribution was equal to 5 minus the scale position. Then, the scores were summed and multiplied by 2.5 to obtain the overall value of SUS. Scores can range from 0 to 100. SUS is evaluated according to Bangor research guidelines (Bangor et al., An Empirical Evaluation of the System Usability Scale, International Journal of Human-Computer Interaction, 2008, 24:574-594): scores in the ranges [55, 75], [75.1, 87.5] and [87.6, 100] indicated respectively "good", "excellent" and "very excellent". Brooke, SUS - A quick and dirty usability scale, Usability evaluation in industry, 1996, 194:4-7. |
Within 15 days from the baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GIP-530
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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