Shoulder Injuries and DisordersCRMINAIL08NCT04758520
Usability and Acceptance of a New Robotic Exoskeleton for Shoulder Rehabilitation
A study testing FLOAT upper limb exoskeleton in people with Shoulder Injuries and Disorders, run by Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro at 1 site in Italy.
Trial summary
The purpose of this pilot study is to validate the safety, reliability and usability of FLOAT medical device, a prototypal robotic system for the rehabilitation of the shoulder, designed and developed in the Rehab Technologies IIT-INAIL Lab to fulfil the needs orthopaedic conditions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Injuries and Disorders
- What is being tested?
- FLOAT upper limb exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteItaly
- Study dates
- 20 Nov 2020to 21 Feb 2022
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Height between 160 and 185 cm;
- Distance between the shoulder joint center and the sagittal plane between 156 and 197 mm;
- Shoulder joint center to wall distance between 82 and 142 mm
- Maximum shoulter radius: 120 mm
- Distance between the shoulder joint center and the elbow joint center between 250 and 303 mm
- Time from acute event ≥ 60 days
Show all 10Show fewer
- Right shoulder joint disfunction after orthopaedic injury or surgery as a result of work accidents
- Post-immobilization phase
- At least 80° shoulder passive flexion and 45° shoulder passive abduction
- Pain intensity on movement < 6 NRS;
Who cannot join
- Glenohumeral joint instability
- Shoulder Prosthetic implants
- Upper arm sensorimotor deficits
- Chronic inflammatory disorder involving upper arm joints
- Pseudoarthrosis of the proximal humerus fractures
- Spinal fractures within the last 3 months
Show all 9Show fewer
- Open skin at the level of the patient-device interface
- Current or prior history of malignancy
- Pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
Italy1 site
INAIL - Centro di Riabilitazione Motoria di Volterra
Volterra, Pisa, 56048
About this study
Official title: Motor Rehabilitation of the Shoulder Complex After Orthopaedic Injury or Surgery Because of Work Accidents: a Pilot Study.
The purpose of this pilot study is to validate the safety, reliability and usability of FLOAT medical device, a prototypal robotic system for the rehabilitation of the shoulder, designed and developed in the Rehab Technologies IIT-INAIL Lab to fulfil the needs orthopaedic conditions. The acceptance from patients and therapists will be assessed after a single session of robotic therapy in a sample of injured workers suffering from post-traumatic or post-surgical shoulder disorders.
Read the detailed description
This study aims to:
- Test the safety and reliability of the FLOAT device for delivering post-acute motor and functional rehabilitation of patients with orthopaedic shoulder dysfunction.
- Assess the three different modalities of utilization of the exoskeleton (Passive Mode, Learn\&Repeat Mode, Transparency Mode).
- Evaluate the usability of the device in terms of comfort, adaptability to different patients' anthropometrics, general functioning and overall satisfaction.
Six injured workers with shoulder post-traumatic and post-operative dysfunction will be enrolled in a single testing session at the INAIL Rehabilitation Center in Volterra. Pilot testing of FLOAT device will focus mainly on the feasibility of implementing the multiple operating modes of the new device, recording patients and therapist's feedback. The session will last about 3 hours and all exercises will be administered by a trained physical therapist supported by a member of the engineering team.
For Aim 1, Safety and Reliability of the device will be evaluated in terms of the number of adverse events and malfunctions occurring during the study session.
For Aim 2, each modality will be assessed by means of the Numeric Pain Rating Scale (NPRS), The Borg CR10 Scale Perceived Exertion (only for the Transparent mode) and ad-hoc clinician-generated questionnaires for both patients and therapists.
For aim 3, patient and therapist's general evaluation about usability will be detected through a final ad-hoc questionnaire.
- Conditions
- Shoulder Injuries and Disorders
- Being tested
- FLOAT upper limb exoskeleton
- Keywords
- Adult, Deseases/musculoskeletal, Feasibility Studies, Humans, Occupational Therapy, Rehabilitation Research, Robotics, Shoulder Joint / therapy, Upper arm/therapy, Wearable devices
- Medical subject headings
- Shoulder Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLOAT upper limb exoskeletonDevice
The FLOAT device is composed by a wearable exoskeleton assembled on a poly-articulated arm that, in turn, is mounted on a support base with unlockable wheels. The exoskeleton includes 5 motors arranged in a way that, when generating movement, ensures the optimal involvement of all the articulations of the shoulder complex, particularly the glenohumeral and the scapulothoracic joints. According to the chosen modality of use of the exoskeleton, the device allows patient's passive or active-assisted mobilization. The poly-articulated arm supporting the exoskeleton is capable to compensate exoskeleton weight in every configuration and, if configured appropriately, permits exoskeleton use both in seated and standing positions. The support base of the device has unlockable wheels that, if unlocked, permit the free movement of the patient in the workspace, enabling the performance of more complex functional activities while assisted by the exoskeleton.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Six subjects are involved in a single session of upper limb robotic-assisted therapy lasting about 3 hours and including:
* passive mobilization of patient's upper arm along elementary shoulder movements:shoulder flexion/extension, adduction/ abduction in the frontal plane, horizontal adduction/ abduction, intra/extrarotation (Passive Mode);
* passive mobilization of patient's upper arm along complex trajectories recorded from manual mobilization of the therapist (Learn\&Replay Mode);
* active mobilization, performed by the patient during rehabilitative functional tasks, relying only on gravity and friction compensations and tuneable assistance from the exoskeleton (Transparency Mode). Receives: Device: FLOAT upper limb exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
The physiotherapist is required to report any adverse events occurring during the study in regard to the use of FLOAT, for the purpose of evaluating the safety of the device
Measured: 1 year
Number of device malfunctions
The physiotherapist is required to report any malfunctions occurring during the study in regard to the use of FLOAT, for the purpose of evaluating the reliability of the device
Measured: 1 year
Secondary outcomes (6)
Numeric Pain Rating Scale (NPRS)
NPRS is an 11-point scale for patient self-reporting of pain, with 0 being "no pain" and 10 being "the worst pain imaginable"; It will be administered after each series of joint mobilization exercises.
Measured: 1 year
The Borg Category-Ratio Scale (CR-10)
The Borg CR10 Scale is a tool for estimating effort and exertion, breathlessness, and fatigue during physical work, with rating ranges from 0 (nothing at all) to 10 (extremely strong).
It will be administered after each series of functional tasks in transparent mode
Measured: 1 year
Ad-hoc questionnaires for the patient, one for each of the three modalities (for a total amount of 3 questionnaires)
Clinician-generated questionnaire to investigate patients' impressions about the physical interaction with the robotic device using the specific modality. Each questionnaire consists of a series of items with 5-point rating scale (1= not at all, 5=very well)
Measured: After the completion of the testing session with each of the three modalities
Ad-hoc questionnaires for the therapist, one for each of the three modalities (for a total amount of 3 questionnaires)
Clinician-generated questionnaire to investigate therapist's impressions about the usability and efficiency the robotic device using the specific modality. It will be administered after the completion of the testing session with each of the three modalities. Each questionnaire consists of a series of items with 5-point rating scale (1=not at all, 5=very well)
Measured: 1 year
Ad-hoc questionnaire for the patient (final evaluation)
Clinician-generated questionnaire to investigate patients' general evaluation about FLOAT usability. The questionnaire consists of a series of items with 5-point rating scale (1=not at all, 5=very well)
Measured: 1 year (at the end of the study)
Ad-hoc questionnaire for the therapist (final evaluation)
Clinician-generated questionnaire to investigate therapists' general evaluation about FLOAT usability. The questionnaire consists of a series of items with 5-point rating scale (1=not at all, 5=very well)
Measured: 1 year (at the end of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start20 Nov 2020
- Primary completion21 Feb 2022
- Study completion21 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Injuries and DisordersStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Italiano di Tecnologia
- Responsible party
- Sponsor
- Investigators
- Elisa Taglione, MD, Principal investigator, Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758520
- Sponsor's protocol ID
- CRMINAIL08
- Acronym
- CRMINAIL08
- Status last verified
- Mar 2022
- First submitted
- 9 Feb 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Rehabilitation of the Shoulder Complex After Orthopaedic Injury or Surgery Because of Work Accidents: a Pilot Study.
- ClinicalTrials.gov ID
- NCT04758520
- Acronym / sponsor ID
- CRMINAIL08 / CRMINAIL08
- Conditions
- Shoulder Injuries and Disorders
- Keywords
- Adult, Deseases/musculoskeletal, Feasibility Studies, Humans, Occupational Therapy, Rehabilitation Research, Robotics, Shoulder Joint / therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Istituto Nazionale Assicurazione contro gli Infortuni sul LavoroUniversity, hospital or other
- Collaborators
- Istituto Italiano di Tecnologia
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 21 Feb 2022 (actual)
- Study completion
- 21 Feb 2022 (actual)
- First posted
- 17 Feb 2021 (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 purpose of this pilot study is to validate the safety, reliability and usability of FLOAT medical device, a prototypal robotic system for the rehabilitation of the shoulder, designed and developed in the Rehab Technologies IIT-INAIL Lab to fulfil the needs orthopaedic conditions. The acceptance from patients and therapists will be assessed after a single session of robotic therapy in a sample of injured workers suffering from post-traumatic or post-surgical shoulder disorders.
Detailed description
This study aims to:
- Test the safety and reliability of the FLOAT device for delivering post-acute motor and functional rehabilitation of patients with orthopaedic shoulder dysfunction.
- Assess the three different modalities of utilization of the exoskeleton (Passive Mode, Learn\&Repeat Mode, Transparency Mode).
- Evaluate the usability of the device in terms of comfort, adaptability to different patients' anthropometrics, general functioning and overall satisfaction.
Six injured workers with shoulder post-traumatic and post-operative dysfunction will be enrolled in a single testing session at the INAIL Rehabilitation Center in Volterra. Pilot testing of FLOAT device will focus mainly on the feasibility of implementing the multiple operating modes of the new device, recording patients and therapist's feedback. The session will last about 3 hours and all exercises will be administered by a trained physical therapist supported by a member of the engineering team.
For Aim 1, Safety and Reliability of the device will be evaluated in terms of the number of adverse events and malfunctions occurring during the study session.
For Aim 2, each modality will be assessed by means of the Numeric Pain Rating Scale (NPRS), The Borg CR10 Scale Perceived Exertion (only for the Transparent mode) and ad-hoc clinician-generated questionnaires for both patients and therapists.
For aim 3, patient and therapist's general evaluation about usability will be detected through a final ad-hoc questionnaire.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: FLOAT upper limb exoskeletonSix subjects are involved in a single session of upper limb robotic-assisted therapy lasting about 3 hours and including: * passive mobilization of patient's upper arm along elementary shoulder movements:shoulder flexion/extension, adduction/ abduction in the frontal plane, horizontal adduction/ abduction, intra/extrarotation (Passive Mode); * passive mobilization of patient's upper arm along complex trajectories recorded from manual mobilization of the therapist (Learn\&Replay Mode); * active mobilization, performed by the patient during rehabilitative functional tasks, relying only on gravity and friction compensations and tuneable assistance from the exoskeleton (Transparency Mode). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Height between 160 and 185 cm;
- Distance between the shoulder joint center and the sagittal plane between 156 and 197 mm;
- Shoulder joint center to wall distance between 82 and 142 mm
- Maximum shoulter radius: 120 mm
- Distance between the shoulder joint center and the elbow joint center between 250 and 303 mm
Key exclusion criteria (9 listed)
- Glenohumeral joint instability
- Shoulder Prosthetic implants
- Upper arm sensorimotor deficits
- Chronic inflammatory disorder involving upper arm joints
- Pseudoarthrosis of the proximal humerus fractures
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 |
|---|---|---|
| FLOAT upper limb exoskeletonThe FLOAT device is composed by a wearable exoskeleton assembled on a poly-articulated arm that, in turn, is mounted on a support base with unlockable wheels. The exoskeleton includes 5 motors arranged in a way that, when generating movement, ensures the optimal involvement of all the articulations of the shoulder complex, particularly the glenohumeral and the scapulothoracic joints. According to the chosen modality of use of the exoskeleton, the device allows patient's passive or active-assisted mobilization. The poly-articulated arm supporting the exoskeleton is capable to compensate exoskeleton weight in every configuration and, if configured appropriately, permits exoskeleton use both in seated and standing positions. The support base of the device has unlockable wheels that, if unlocked, permit the free movement of the patient in the workspace, enabling the performance of more complex functional activities while assisted by the exoskeleton. | Device | Experimental |
Primary outcome
Number of adverse events
Time frame: 1 year
The physiotherapist is required to report any adverse events occurring during the study in regard to the use of FLOAT, for the purpose of evaluating the safety of the device
Number of device malfunctions
Time frame: 1 year
The physiotherapist is required to report any malfunctions occurring during the study in regard to the use of FLOAT, for the purpose of evaluating the reliability of the device
6 secondary outcomes
Numeric Pain Rating Scale (NPRS)
Time frame: 1 year
The Borg Category-Ratio Scale (CR-10)
Time frame: 1 year
Ad-hoc questionnaires for the patient, one for each of the three modalities (for a total amount of 3 questionnaires)
Time frame: After the completion of the testing session with each of the three modalities
Ad-hoc questionnaires for the therapist, one for each of the three modalities (for a total amount of 3 questionnaires)
Time frame: 1 year
Ad-hoc questionnaire for the patient (final evaluation)
Time frame: 1 year (at the end of the study)
Ad-hoc questionnaire for the therapist (final evaluation)
Time frame: 1 year (at the end of the study)
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 31 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Elisa Taglione, MD principal investigator
Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLOAT upper limb exoskeleton in people with Shoulder Injuries and Disorders, run by Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro at 1 site 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 10 inclusion and 9 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 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of adverse events (time frame: 1 year). The study lists 2 primary outcomes in all. 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 31 Mar 2022.