- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04068454
Virtual Reality in Reeducation : Application to Shoulder Affections
The Use of Virtual Reality in Shoulder Reeducation : Interests and Limits.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Liège
-
Liege, Liège, Belgium, 4000
- University of Liège
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: classical rehabilitation group
|
scapular exercises will be done
|
Experimental: virtual reality group
|
Functional exercises will be done by virtual reality group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
change from baseline at 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
change from baseline at 12 weeks
|
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
|
Change from baseline at 12 weeks
|
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)
|
Change from baseline at 12 weeks
|
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
|
Change from baseline at 12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Camille Tooth, University of Liège
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 002 (University of CT Health Center)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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