Robot Assisted Physical Therapy for Pseudoparalysis in Massive Rotator Cuff Tear

Can Robot Assited Physical Therapy Affect Pseudoparalysis in Patients Treated for Massive Rotator Cuff Tear? A Feasibility Study

The primary objective of this study is to assess the efficacy of a robot assisted therapy in a clinical setting and its potential benefit for patients with rotator cuff tear associated with pseudoparalysis. eighty patients with clinical signs of pseudoparalysis will be recruited through doctors and physical therapists based on eligibility criteria. After completing the baseline assessments, patients will be randomized into the robot-assisted physical therapy intervention or control comparison group. 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 post intervention.

Study Overview

• Status: Available
• Conditions: Pseudoparalysis Due to Massive Rotator Cuff Tear
• Intervention / Treatment: Device: Robotic assisted therapy with MJS (multi joint system) Tecnobody; Other: Usual Care

Detailed Description

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.

Eighty 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 attend 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 post intervention. Primary analysis will be descriptive and secondary analysis will be analyzed 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. We will follow a repeated measures analysis to investigate changes in the outcomes variables across time. This approach allows for the examination of within-subject differences, making it particularly useful in studying interventions or treatments where individuals serve as their own control.

• Study Type: Expanded Access
• Expanded Access Type: Individual Patients
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zürich, ZH, Switzerland, 8008
      • Available
      • Schulthess Klinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic mediated therapy; Robotic mediated therapy with MJS (multi joint system) Tecnobody	Device: Robotic mediated therapy with MJS (multi joint system) Tecnobody; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Schulthess Klinik
• Investigators: Principal Investigator: Markus Scheibel, Dr, Schulthess Klinik

Study record dates

Study Major Dates

• Study Start: June 1, 2019
• Primary Completion: March 31, 2020
• Study Completion: June 30, 2020

Study Registration Dates

• First Submitted: April 3, 2019
• First Submitted That Met QC Criteria: April 4, 2019
• First Posted (Actual): April 5, 2019

Study Record Updates

• Last Update Posted (Actual): June 7, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Massive rotator cuff tear; Pseudoparalysis; Robotic mediated therapy
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: OE-0067 (RC-Pseudoparalysis)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No