Robot Assisted Physical Therapy for Pseudoparalysis in Massive Rotator Cuff Tear

Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18+
SponsorSchulthess Klinik

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Neurological disease

Clinical diagnosis of rheumatoid arthritis, glenohumeral osteoarthritis, periarthritis and necrosis

RC repair in the previous two years

Acute fracture

Trial design

Treatments tested in this trial

  • Robotic assisted therapy with MJS (multi joint system) Tecnobody
  • Usual Care

Treatment groups

No treatment groups listed

Sponsors and collaborators