Shoulder Injuries and Disorders Clinical Trial
— CRMINAIL08Official title:
Motor Rehabilitation of the Shoulder Complex After Orthopaedic Injury or Surgery Because of Work Accidents: a Pilot Study.
Verified date | March 2022 |
Source | Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 6 |
Est. completion date | February 21, 2022 |
Est. primary completion date | February 21, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - 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 - 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; Exclusion Criteria: - 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 - Open skin at the level of the patient-device interface - Current or prior history of malignancy - Pregnancy or breast feeding |
Country | Name | City | State |
---|---|---|---|
Italy | INAIL - Centro di Riabilitazione Motoria di Volterra | Volterra | Pisa |
Lead Sponsor | Collaborator |
---|---|
Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro | Istituto Italiano di Tecnologia |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 1 year | |
Primary | 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 | 1 year | |
Secondary | 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. | 1 year | |
Secondary | 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 |
1 year | |
Secondary | 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) | After the completion of the testing session with each of the three modalities | |
Secondary | 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) | 1 year | |
Secondary | 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) | 1 year (at the end of the study) | |
Secondary | 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) | 1 year (at the end of the study) |
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