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Virtual Reality in Reeducation : Application to Shoulder Affections

Primary Purpose

Scapular Dyskinesis, Shoulder Pain

Status
Active
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Virtual reality device
EBM rehabilitation exercises
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scapular Dyskinesis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Liege

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

classical rehabilitation group

virtual reality group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Shoulder pain
Shoulder pain will be assessed, with a maximum score of 10 (0= no pain and 10= maximum pain)
EMG activity
EMG activity of upper trapezius, lower trapezius and serratus anterior will be assessed using surface EMG
3D scapular motion
Scapular motion will be assessed when doing elevations in sagittal and frontal planes (in loaded and unloaded conditions)
Maximum voluntary isometric contraction
Maximum isometric strength will be assessed in 3 different positions (SeatedU90°, SeatedU125°, Prone-v-thumbs up) with handheld dynamometer

Full Information

First Posted
March 21, 2019
Last Updated
November 23, 2022
Sponsor
University of Liege
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1. Study Identification

Unique Protocol Identification Number
NCT04068454
Brief Title
Virtual Reality in Reeducation : Application to Shoulder Affections
Official Title
The Use of Virtual Reality in Shoulder Reeducation : Interests and Limits.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scapular Dyskinesis, Shoulder Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
classical rehabilitation group
Arm Type
Active Comparator
Arm Title
virtual reality group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Virtual reality device
Intervention Description
Functional exercises will be done by virtual reality group
Intervention Type
Other
Intervention Name(s)
EBM rehabilitation exercises
Intervention Description
scapular exercises will be done
Primary Outcome Measure Information:
Title
Score of Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Description
Functional ability and quality of life will be assessed using this questionnaire, with a maximal score of 100
Time Frame
change from baseline at 12 weeks
Secondary Outcome Measure Information:
Title
Shoulder pain
Description
Shoulder pain will be assessed, with a maximum score of 10 (0= no pain and 10= maximum pain)
Time Frame
change from baseline at 12 weeks
Title
EMG activity
Description
EMG activity of upper trapezius, lower trapezius and serratus anterior will be assessed using surface EMG
Time Frame
Change from baseline at 12 weeks
Title
3D scapular motion
Description
Scapular motion will be assessed when doing elevations in sagittal and frontal planes (in loaded and unloaded conditions)
Time Frame
Change from baseline at 12 weeks
Title
Maximum voluntary isometric contraction
Description
Maximum isometric strength will be assessed in 3 different positions (SeatedU90°, SeatedU125°, Prone-v-thumbs up) with handheld dynamometer
Time Frame
Change from baseline at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camille Tooth
Organizational Affiliation
University of Liege
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Liege
City
Liege
State/Province
Liège
ZIP/Postal Code
4000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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Virtual Reality in Reeducation : Application to Shoulder Affections

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