Effectiveness of Instrumental Rehabilitation in Patients With Adhesive Capsulitis

NCT06766448 | Recruiting

• 1 other identifier: C63-20
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Adhesive Capsulitis of the Shoulder

Keywords

adhesive capsulitis; rehabilitation; robotic training

Outcome Measures

Primary Outcomes (1)

• shoulder fonction using Shoulder Pain and Disability Index (SPADI)

  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 Outcomes (2)

• pain using a visual analogue scale

  at 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months

• Active and passive range of motion

  at 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months

Study Arms (2)

intervention group

EXPERIMENTAL

the intervention group will receive robotic training

Other: robotic training

control group

ACTIVE COMPARATOR

control group will receive conventionnal rehabilitation

Other: conventionnal rehabilitation

Interventions

robotic training OTHER

continuous passive mobilization and robotic therapy on armeo sping

intervention group

conventionnal rehabilitation OTHER

rehabilitation sessions with a physiotherapist

control group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mohammed V Souissi University: lead

Study Sites (1)

Faculty of medecine and pharmacy of rabat

Rabat, 10000, Morocco

RECRUITING

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• samia karkouri, professor

  Mohammed V Souissi University

  STUDY CHAIR

Central Study Contacts

sara skalli, doctor

CONTACT

+212661504251; dr.skalli.sara@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: January 4, 2025
• First Posted: January 9, 2025
• Study Start: March 23, 2021
• Primary Completion: January 2, 2025
• Study Completion: April 1, 2025
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: start january 2025 end may 2025
• Access Criteria: doctors in the rehabilitation field can ask access by sending an email to the principal investigator

Locations

MO (1)