A Neuromuscular Exercise Program for Patients With Anterior Shoulder Instability

NCT02371928 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2018-03-09

No results posted yet for this study

Summary

This study is designed to investigate the efficacy and safety of a supervised neuromuscular exercise program versus a standard home exercise program for patients with post-traumatic symptomatic anterior shoulder instability.

Participants with at least one week of symptom duration are randomly assigned to either a 12-week structured, supervised Shoulder Instability Neuromuscular EXercise (SINEX) program versus a standard HOMe EXercise (HOMEX) program.

The H1-hypothesis is that the SINEX program results in a greater increase in quality of life and physical function than the HOMEX program at the primary endpoint at three months follow-up from baseline

Conditions

  • Shoulder Dislocation
  • Musculoskeletal Diseases

Interventions

OTHER

Neuromuscular exercise program

Exercises can be individually progressed from basic to elite level. Low load exercises are performed every day with 2 sets of 20-25 repetitions whereas high load exercises are performed three times per week with 2 sets of 8-12 repetitions. Exercises are progressed using the following components: arm-position, load, speed, open/closed eyes, stable/unstable surfaces. Patients have online access to instructions and video recordings of all exercises and progression levels. Patients are trained to continuously evaluate their own shoulder function and to adjust the exercise levels themselves at home. Supervision will be given two times a week for the first two weeks and then once a week for the remaining period.

OTHER

Standard home exercise program

Strengthening of the rotator cuff muscles are performed with the use of elastic bands (shoulder internal and external rotation besides abduction in scapular plane) whereas mobility/strengthening exercise for the scapular muscles are performed through weight-bearing positions and movements of the upper extremity. All exercises are performed three times a week with 2 sets of 10 repetitions.

Sponsors & Collaborators

  • Region of Southern Denmark

    collaborator OTHER
  • The Danish Rheumatism Association

    collaborator OTHER
  • Aalborg University Hospital

    collaborator OTHER
  • University of Southern Denmark

    lead OTHER

Principal Investigators

  • Henrik Eshoj, PhD-student · Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark

  • Birgit Juul-Kristensen, Ass. Prof · Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark

  • Karen Søgaard, Prof. · Research Unit for Physical Activity and Health in Working Life, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark

  • Lars H Frich, MD · Shoulder sector, Orthopaedic Department, Odense University Hospital, Denmark

  • Steen L Jensen, MD · Shoulder sector, Orthopedic Department, Aalborg University Hospital, Farsø Hospital, Denmark

  • Sten Rasmussen, MD · Department of Clinical Medicine, Aalborg University, Aalborg, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02371928 on ClinicalTrials.gov