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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04068454
Other study ID # 002
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 1, 2019
Est. completion date August 31, 2024

Study information

Verified date November 2023
Source University of Liege
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 50
Est. completion date August 31, 2024
Est. primary completion date August 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Virtual reality device
Functional exercises will be done by virtual reality group
Other:
EBM rehabilitation exercises
scapular exercises will be done

Locations

Country Name City State
Belgium University of Liege Liege Liège

Sponsors (1)

Lead Sponsor Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Score of Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire 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 Shoulder pain Shoulder pain will be assessed, with a maximum score of 10 (0= no pain and 10= maximum pain) change from baseline at 12 weeks
Secondary EMG activity EMG activity of upper trapezius, lower trapezius and serratus anterior will be assessed using surface EMG Change from baseline at 12 weeks
Secondary 3D scapular motion Scapular motion will be assessed when doing elevations in sagittal and frontal planes (in loaded and unloaded conditions) Change from baseline at 12 weeks
Secondary Maximum voluntary isometric contraction 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
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