Back to resultsWearability, Saefty and Usability Assessment for the Upper Limb Exoskeleton BRIDGE/EMPATIA
Primary Purpose
Muscular Dystrophies
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
BRIDGE/EMPATIA exoskeleton
Sponsored by
About this trial
This is an interventional other trial for Muscular Dystrophies focused on measuring Exoskeleton, Upper limb, Assistive device
Eligibility Criteria
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
Sites / Locations
- IRCCS E. Medea - La Nostra Famiglia
- Villa Beretta
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental group
Arm Description
Each participant is evaluated while wearing or not wearing the device.
Outcomes
Primary Outcome Measures
Performance of Upper Limbs scale (PUL)
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.
Secondary Outcome Measures
ABILHAND
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.
Technology acceptance model (TAM) questionnaire
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.
System usability scale (SUS)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03951844
Brief Title
Wearability, Saefty and Usability Assessment for the Upper Limb Exoskeleton BRIDGE/EMPATIA
Official Title
Wearability, Saefty and Usability Assessment for the Upper Limb Exoskeleton BRIDGE/EMPATIA
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 26, 2018 (Actual)
Primary Completion Date
April 2, 2019 (Actual)
Study Completion Date
April 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alessandra Pedrocchi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is a feasibility study or pilot study, that is a clinical investigation to acquire the preliminary information on a motorized exoskeleton (BRIDGE / EMPATIA exoskeleton) for the movement of the upper limb in order to develop it, including design changes. The primary objective of the clinical trial is to assess the fit, safety and usability of the device in supporting the execution of daily activities for patients suffering from muscular dystrophy. The risk analysis for the BRIDGE / EMPATIA device does not present particular criticalities that preclude the use of the device in the target population. In any case, during the trial eventual adverse events are recorded for the verification of safety..
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Dystrophies
Keywords
Exoskeleton, Upper limb, Assistive device
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Each participant is evaluated while wearing or not wearing the device.
Intervention Type
Device
Intervention Name(s)
BRIDGE/EMPATIA exoskeleton
Intervention Description
The participant wears the exoskeleton on his/her left arm, and he/she controls it by means of a joystick or vocal commands.
Primary Outcome Measure Information:
Title
Performance of Upper Limbs scale (PUL)
Description
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.
Time Frame
Change from baseline PUL without the exoskeleton and PUL wearing the exoskeleton within 15 days.
Secondary Outcome Measure Information:
Title
ABILHAND
Description
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.
Time Frame
Change from baseline PUL without the exoskeleton and PUL wearing the exoskeleton within 15 days.
Title
Technology acceptance model (TAM) questionnaire
Description
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.
Time Frame
Within 15 days from the baseline
Title
System usability scale (SUS)
Description
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.
Time Frame
Within 15 days from the baseline
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
IRCCS E. Medea - La Nostra Famiglia
City
Bosisio Parini
State/Province
LC
ZIP/Postal Code
23842
Country
Italy
Facility Name
Villa Beretta
City
Costa Masnaga
State/Province
LC
ZIP/Postal Code
23845
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Wearability, Saefty and Usability Assessment for the Upper Limb Exoskeleton BRIDGE/EMPATIA
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