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Virtual Reality in Reeducation : Application to Shoulder Affections

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ClinicalTrials.gov Identifier: NCT04068454
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Camille Tooth, University of Liege

Brief Summary:
The objective of this study is to assess the interest and the efficiency of virtual reality in functional rehabilitation of shoulder pain and shoulder injuries. Participants will follow a 12-week rehabilitation program based either on exercises or on a program integrating virtual reality. Results obtained with classical rehabilitation will be compared with the one obtained virtual reality.

Condition or disease Intervention/treatment Phase
Scapular Dyskinesis Shoulder Pain Device: Virtual reality device Other: EBM rehabilitation exercises Not Applicable

Detailed Description:

Fifty people will be included in the study. Then, they were randomly separated in two groups : 25 people will do the "classical rehabilitation" and the other 25 will have a treatment with virtual reality.

Each group (virtual reality and "classical rehabilitation") is going to follow 12 weeks of rehabilitation, at a rate of 2x 30 minutes per week. In "virtual reality group", each session will be divided in two parts : 15 minutes of virtual reality exercises and 15 minutes of exercises from "classical program". Exercises suggested in the classical program have been chosen among evidence based exercises described in literature.

Before the beginning of rehabilitation sessions, participants will be assessed at the Laboratory of Human Motion Analysis of the University of Liege. At this place, EMG activity of periscapular muscles (upper trapezius, lower trapezius and serratus anterior) (Delsys Trigno) , 3D scapular kinematics (Codamotion) will be assessed on the painful side when doing shoulder elevations in sagittal and in frontal planes. Maximum isometric strength will also be assessed using handheld dynamometer (MicroFet2) in 3 different positions (SeatedU90°, SeatedU125°, Prone-v-thumbs up)

This first evaluation will be done after the 12 week of rehabilitation too, with the same method.

Participants will also have to complete Dash (Disability of the Arm, Shoulder and Hand) questionnaire 3 times during the study (at the beginning, at 6 weeks and at the end of the study). Moreover, pain score will be asked to participants at each rehabilitation session.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Virtual Reality in Shoulder Reeducation : Interests and Limits.
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Active Comparator: classical rehabilitation group Other: EBM rehabilitation exercises
scapular exercises will be done

Experimental: virtual reality group Device: Virtual reality device
Functional exercises will be done by virtual reality group




Primary Outcome Measures :
  1. Score of Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire [ Time Frame: change from baseline at 12 weeks ]
    Functional ability and quality of life will be assessed using this questionnaire, with a maximal score of 100


Secondary Outcome Measures :
  1. Shoulder pain [ Time Frame: change from baseline at 12 weeks ]
    Shoulder pain will be assessed, with a maximum score of 10 (0= no pain and 10= maximum pain)

  2. EMG activity [ Time Frame: Change from baseline at 12 weeks ]
    EMG activity of upper trapezius, lower trapezius and serratus anterior will be assessed using surface EMG

  3. 3D scapular motion [ Time Frame: Change from baseline at 12 weeks ]
    Scapular motion will be assessed when doing elevations in sagittal and frontal planes (in loaded and unloaded conditions)

  4. Maximum voluntary isometric contraction [ Time Frame: Change from baseline at 12 weeks ]
    Maximum isometric strength will be assessed in 3 different positions (SeatedU90°, SeatedU125°, Prone-v-thumbs up) with handheld dynamometer



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • unilateral scapular dyskinesis
  • positive scapular assistance test and positive resistance test
  • shoulder pain
  • ability to play sport despite shoulder pain
  • one or more positive tendinous tests

Exclusion criteria :

  • traumatic history of shoulder injury in the last 6 months
  • surgical history at shoulder or cervical location
  • scoliosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068454


Contacts
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Contact: Camille Tooth +32495363755 ctooth@uliege.be

Locations
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Belgium
University of Liege Recruiting
Liege, Liège, Belgium, 4000
Contact: Camille Tooth    +32495363755    ctooth@uliege.be   
Principal Investigator: Camille Tooth         
Sponsors and Collaborators
University of Liege
Investigators
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Principal Investigator: Camille Tooth University of Liege
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Responsible Party: Camille Tooth, Principal Investigator, University of Liege
ClinicalTrials.gov Identifier: NCT04068454    
Other Study ID Numbers: 002
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms