Effectiveness of Instrumental Rehabilitation in Patients With Adhesive Capsulitis

January 30, 2025 updated by: SARA SKALLI, Mohammed V Souissi University

Robotic Training in the Management of Adhesive Capsulitis: a Randomized Controlled Trial

The aim of this study is to evaluate the effectiveness of robotic training compared to conventional rehabilitation in patients with AC.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Nowadays, rehabilitation focuses on functional work during physiotherapy sessions to improve the patient's autonomy.

In the era of new technologies, robotics and virtual reality have shown great interest in functional rehabilitation and cortical reorganization.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Morocco
      • Rabat, Morocco, 10000
        • Recruiting
        • Faculty of Medecine And Pharmacy Of Rabat
        • Contact:
        • Principal Investigator:
          • sara skalli, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients >18 years of age
  • Shoulder pain and/or movement limitation
  • Idiopathic AC or associated with confirmed systemic disease (e.g., diabetes or dyslipidemia)

Exclusion Criteria:

  • Cognitive impairment
  • History of surgery
  • Fracture or dislocation of the shoulder
  • History of shoulder tendinopathy
  • History of inflammatory or degenerative disease
  • Infection
  • Neurological disease (Parkinson's disease, stroke, multiple sclerosis, neurological
  • Manipulation under anesthesia, hydro dilation, platelet rich plasma or hyaluronic acid infiltration within the last 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group
the intervention group will receive robotic training
Other: robotic training
continuous passive mobilization and robotic therapy on armeo sping
Active Comparator: control group
control group will receive conventionnal rehabilitation
Other: conventionnal rehabilitation
rehabilitation sessions with a physiotherapist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
shoulder fonction using Shoulder Pain and Disability Index (SPADI)
Time Frame: at 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months
It is a self-written questionnaire. It consists of twosubscales. The first assesses the importance of pain felt on five items. Pain scores range from 0 to 50. The second evaluates the difficulty of activities of daily living based on eight. Scores range from 0 to 80.questions
at 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain using a visual analogue scale
Time Frame: at 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months
It is a 100mm ruler that allows patients to rank their pain on a continuum from no pain to extreme pain. The patient places the indicator on a level that represents their current pain.
at 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months
Active and passive range of motion
Time Frame: at 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months
Active and passive range of motion is clinically assessed using a goniometer while standing. We measured abduction, extension and external rotation.
at 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mohammed V Souissi University

Investigators

  • Study Chair: samia karkouri, professor, Mohammed V Souissi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2021

Primary Completion (Actual)

January 2, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

January 4, 2025

First Submitted That Met QC Criteria

January 4, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 30, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C63-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

excell table of data

IPD Sharing Time Frame

start january 2025 end may 2025

IPD Sharing Access Criteria

doctors in the rehabilitation field can ask access by sending an email to the principal investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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