Robotic Mediated Therapy for Pseudoparalysis in Massive Rotator Cuff Tear

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the feasibility of a robotic mediated therapy in a clinical setting and its potential benefit for patients with rotator cuff tear associated with pseudoparalysis. Ten patients with clinical signs of pseudoparalysis will be recruited through doctors and physical therapists based on eligibility criteria. Enrolled patients will conduct a specific trainings program with the MJS Tecnobody (Multi Joint System 614P Tecnobody Srl, IT) three times a week over a period of six weeks. Feasibility assessment will be performed six and twelve weeks after baseline and secondary outcomes (Oxford shoulder score, subjective shoulder value, pain level during activity of daily living, active shoulder flexion and abduction and quality of life EQ-5D-5L)will be assessed at baseline, six and twelve weeks after the beginning. Statistical analysis will be descriptive and secondary analysis will be analysed with a univariate paired non-parametric analysis.

Detailed Description
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Rotator cuff tears are a common disorder in chronic shoulder pain. Common Complaints are pain, loss of range of motion and loss of strength. 20% of all tears are massive, in re-ruptures even 80%, with at least two tendons involved and this could lead to pseudoparalysis. The recommendation for the initial treatment is non-operative with physical therapy although people often receive a shoulder endoprosthesis. Robotic mediated therapy in patients with neurological disorders is already common, in rotator cuff tears it is less frequent and evidence is rare though. Therefore, the primary objective of this study is to evaluate the feasibility of a robotic mediated therapy in a clinical setting, in terms of satisfaction, compliance and tolerance, and its potential benefit for patients with rotator cuff tear associated with pseudoparalysis. Ten patients with clinical signs of pseudoparalysis will be recruited in the Schulthess clinic in Zurich through doctors and physical therapists of the shoulder and elbow surgery department based on eligibility criteria. Eligible patient will be enclosed after signing the informed consent. The patients will conduct a specific trainings program with the MJS Tecnobody (Multi Joint System 614P Tecnobody Srl, IT) three times a week over a period of six weeks. The training is guided by a specialised physical therapist and the trainings program is developed by physical therapists and doctors of the Schulthess clinic based on current literature. Feasibility assessment will be performed six and twelve weeks after baseline and secondary outcomes (Oxford shoulder score, subjective shoulder value, pain level during activity of daily living, active shoulder flexion and abduction and quality of life EQ-5D-5L) will be assessed at baseline, six and twelve weeks after the beginning. Primary analysis will be descriptive and secondary analysis will be analysed with a univariate paired non-parametric analysis. All statistical tests will be two-sided and the level of significance will be set at p < 0.05. All analyses will be exploratory. The author expects, based on recent literature, that patients will accept well the MJS treatment and show high compliance and satisfaction, in particular if it is associated with improved active range of motion, shoulder function and quality of life at final follow-up.

Official Title
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Can Robotic Mediated Therapy Affect Pseudoparalysis in Patients Treated for Massive Rotator Cuff Tear? A Feasibility Study

Conditions
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Pseudoparalysis Due to Massive Rotator Cuff Tear

Intervention / Treatment
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* Device: Robotic mediated therapy with MJS (multi joint system) Tecnobody


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active flexion <45° Massive, irreparable, atraumatic RC tear at least two tendons Almost full passive ROM glenohumeral (140-180°) Fatty infiltration of the muscle Goutallier grade III or IV Persistent loss of active ROM after injection Ability to speak and understand German or English Exclusion Criteria: Neurological disease Clinical diagnosis of rheumatoid arthritis, glenohumeral osteoarthritis, periarthritis and necrosis RC repair in the previous two years Acute fracture Acute traumatic RC tear Capsular shoulder stiffness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic mediated therapy<br>Robotic mediated therapy with MJS (multi joint system) Tecnobody | Device: Robotic mediated therapy with MJS (multi joint system) Tecnobody<br>* The intervention will include 18 30-minutes trainings evenly distributed over a time period of 6 weeks and will be administered by the same two physiotherapists at the Schulthess clinic based on the standardized protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Numeric rating scale (NRS) from 0=not at all satisfied to 10=fully satisfied | 3 months | 
| Treatment compliance | Adherence of training in % of the 18 planned sessions | 6 weeks | 
| Treatment tolerance | Pain Level during and after Training NRS 0=no pain to 10=maximum pain | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder range of motion | Active ROM shoulder flexion and abduction | 3 months | 
| OSS | Oxford shoulder score (0-48) | 3 months | 
| SSV | Subjective shoulder value (0-100%) | 3 months | 
| Pain NRS | Pain during ADL (activity of daily living): NRS 0 = no pain to 10 = maximum pain | 3 months | 
| EQ-5D utilities | Quality of life (EuroQol EQ-5D-5L) | 3 months | 
| AE | Adverse events | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Massive rotator cuff tear, Pseudoparalysis, Robotic mediated therapy