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出境医 / 临床实验 / Wearability, Saefty and Usability Assessment for the Upper Limb Exoskeleton BRIDGE/EMPATIA

Wearability, Saefty and Usability Assessment for the Upper Limb Exoskeleton BRIDGE/EMPATIA

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..

Condition or disease Intervention/treatment Phase
Muscular Dystrophies Device: BRIDGE/EMPATIA exoskeleton Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Wearability, Saefty and Usability Assessment for the Upper Limb Exoskeleton BRIDGE/EMPATIA
Actual Study Start Date : June 26, 2018
Actual Primary Completion Date : April 2, 2019
Actual Study Completion Date : April 2, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Experimental group
Each participant is evaluated while wearing or not wearing the device.
 Device: BRIDGE/EMPATIA exoskeleton
The participant wears the exoskeleton on his/her left arm, and he/she controls it by means of a joystick or vocal commands.
Outcome Measures
Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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.

  3. 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.



Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Availability of the patient and/or caregiver at the signing of the informed consent for participation in a clinical trial study protocol
  2. 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.
  3. Wheelchair bounded
  4. 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)
  5. Cognitive skills that allow the understanding and management of the device
  6. 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:

  1. Presence of important comorbidities (epilepsy, dependence 24/24 hours from non-invasive and invasive ventilation)
  2. Behavioral and psychiatric disorders (e.g., emotional problems, depression)
  3. Inability to maintain a sitting position in a wheelchair
Contacts and Locations

Locations
Layout table for location information
Italy
IRCCS E. Medea - La Nostra Famiglia
Bosisio Parini, LC, Italy, 23842
Villa Beretta
Costa Masnaga, LC, Italy, 23845
Sponsors and Collaborators
Alessandra Pedrocchi
Tracking Information
First Submitted Date  ICMJE May 13, 2019
First Posted Date  ICMJE May 15, 2019
Last Update Posted Date May 17, 2019
Actual Study Start Date  ICMJE June 26, 2018
Actual Primary Completion Date April 2, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2019) 		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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019) 		Performance of Upper Limbs (PUL) scale [ Time Frame: Change from baseline PUL without the exoskeleton and PUL wearing the exoskeleton within 15 days. ]
Pane et al., "Reliability of the Performance of Upper Limb assessment in Duchenne muscular dystrophy," Neuromuscular disorders: NMD, vol. 24, pp. 201-206, Mar. 2014
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • ABILHAND [ Time Frame: Change from baseline PUL without the exoskeleton and PUL wearing the exoskeleton within 15 days. ]
    M. Penta, J. L. Thonnard, and L. Tesio, "ABILHAND: a Rasch-built measure of manual ability," Archives of Physical Medicine and Rehabilitation, vol. 79, pp. 1038-1042, Sept. 1998.
  • Technology acceptance model (TAM) [ 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.
  • System usability scale (SUS) [ Time Frame: Within 15 days from the baseline ]
    J. Brooke, "SUS - A quick and dirty usability scale," Usability evaluation in industry, no. 194, pp. 4-7, 1996
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Wearability, Saefty and Usability Assessment for the Upper Limb Exoskeleton BRIDGE/EMPATIA
Official Title  ICMJE Wearability, Saefty and Usability Assessment for the Upper Limb Exoskeleton BRIDGE/EMPATIA
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..
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Muscular Dystrophies
Intervention  ICMJE Device: BRIDGE/EMPATIA exoskeleton
The participant wears the exoskeleton on his/her left arm, and he/she controls it by means of a joystick or vocal commands.
Study Arms  ICMJE Experimental: Experimental group
Each participant is evaluated while wearing or not wearing the device.
Intervention: Device: BRIDGE/EMPATIA exoskeleton
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 14, 2019) 		14
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2, 2019
Actual Primary Completion Date April 2, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Availability of the patient and/or caregiver at the signing of the informed consent for participation in a clinical trial study protocol
  2. 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.
  3. Wheelchair bounded
  4. 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)
  5. Cognitive skills that allow the understanding and management of the device
  6. 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:

  1. Presence of important comorbidities (epilepsy, dependence 24/24 hours from non-invasive and invasive ventilation)
  2. Behavioral and psychiatric disorders (e.g., emotional problems, depression)
  3. Inability to maintain a sitting position in a wheelchair
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03951844
Other Study ID Numbers  ICMJE GIP-530
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Alessandra Pedrocchi, Politecnico di Milano
Study Sponsor  ICMJE Alessandra Pedrocchi
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Politecnico di Milano
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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