Robot Assisted Physical Therapy for Pseudoparalysis in Massive Rotator Cuff Tear

NCT03905499 | Unknown

• 1 other identifier: OE-0067 (RC-Pseudoparalysis)
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pseudoparalysis Due to Massive Rotator Cuff Tear

Keywords

Massive rotator cuff tear; Pseudoparalysis; Robotic mediated therapy

Interventions

Robotic assisted therapy with MJS (multi joint system) Tecnobody DEVICE

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

Usual Care OTHER

Patients randomized in the usual care will receive standard of care treatment without receiving any active intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Schulthess Klinik: lead

Study Sites (1)

Schulthess Klinik

Zurich, Canton of Zurich, 8008, Switzerland

AVAILABLE

Study Officials

• Markus Scheibel, Dr

  Schulthess Klinik

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabine Schibli

CONTACT

+41 44 385 7580; sabine.schibli@kws.ch

Asimina Lazaridou

CONTACT

+41 44 385 7580; Asimina.Lazaridou@kws.ch

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 5, 2019
• Last Updated: June 7, 2024

Record last verified: 2024-05

Locations

CH (1)