Muscular DystrophiesNCT03951844
Wearability, Saefty and Usability Assessment for the Upper Limb Exoskeleton BRIDGE/EMPATIA
A study testing BRIDGE/EMPATIA exoskeleton in people with Muscular Dystrophies, run by Alessandra Pedrocchi at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Muscular Dystrophies
- What is being tested?
- BRIDGE/EMPATIA exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesItaly
- Study dates
- 26 Jun 2018to 2 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
IRCCS E. Medea - La Nostra Famiglia
Bosisio Parini, LC, 23842
Villa Beretta
Costa Masnaga, LC, 23845
About this study
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..
- Conditions
- Muscular Dystrophies
- Being tested
- BRIDGE/EMPATIA exoskeleton
- Keywords
- Exoskeleton, Upper limb, Assistive device
- Medical subject headings
- Muscular Dystrophies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRIDGE/EMPATIA exoskeletonDevice
The participant wears the exoskeleton on his/her left arm, and he/she controls it by means of a joystick or vocal commands.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Each participant is evaluated while wearing or not wearing the device. Receives: Device: BRIDGE/EMPATIA exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline PUL without the exoskeleton and PUL wearing the exoskeleton within 15 days.
Secondary outcomes (3)
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.
Measured: Change from baseline PUL without the exoskeleton and PUL wearing the exoskeleton within 15 days.
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.
Measured: Within 15 days from the baseline
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.
Measured: Within 15 days from the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start26 Jun 2018
- Primary completion2 Apr 2019
- Study completion2 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscular DystrophiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alessandra Pedrocchi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alessandra Pedrocchi, Politecnico di Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951844
- Sponsor's protocol ID
- GIP-530
- Status last verified
- May 2019
- First submitted
- 13 May 2019
- Last updated
- 17 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearability, Saefty and Usability Assessment for the Upper Limb Exoskeleton BRIDGE/EMPATIA
- ClinicalTrials.gov ID
- NCT03951844
- Acronym / sponsor ID
- GIP-530
- Conditions
- Muscular Dystrophies
- Keywords
- Exoskeleton, Upper limb, Assistive device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Alessandra PedrocchiUniversity, hospital or other
- Study start
- 26 Jun 2018 (actual)
- Primary completion
- 2 Apr 2019 (actual)
- Study completion
- 2 Apr 2019 (actual)
- First posted
- 15 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: BRIDGE/EMPATIA exoskeletonEach participant is evaluated while wearing or not wearing the device. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BRIDGE/EMPATIA exoskeletonThe participant wears the exoskeleton on his/her left arm, and he/she controls it by means of a joystick or vocal commands. | Device | Experimental group |
Primary outcome
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.
3 secondary outcomes
ABILHAND
Time frame: 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
System usability scale (SUS)
Time frame: Within 15 days from the baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BRIDGE/EMPATIA exoskeleton in people with Muscular Dystrophies, run by Alessandra Pedrocchi at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of Upper Limbs scale (PUL) (time frame: Change from baseline PUL without the exoskeleton and PUL wearing the exoskeleton within 15 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2019.