- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06246305
Effect of Virtual Reality on Upper Extremity Function Post-operative Rotator Cuff Repair
The Effect of Virtual Reality Intervention and Its Impact on Upper Extremity Function in Patients With Post-operative Rotator Cuff Repair
The aim of the study is to investigate the effect and the impact of performing virtual reality intervention on upper extremity function in patients with post-operative rotator cuff repair. The main question that it aims to answer is:
Does the application of virtual reality intervention improves upper extremity function in patients with post-operative rotator cuff repair.
Participants will be randomized into 2 groups: the control group receiving conventional physical therapy intervention and the experimental group receiving the virtual reality intervention.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmed El Melhat, PhD
- Phone Number: 01112595022
- Email: ahmed.elmelhat@cu.edu.eg
Study Contact Backup
- Name: Aseel El kawam, DPT
- Phone Number: 70656958
- Email: aseelkawam@gmail.com
Study Locations
-
-
-
Cairo, Egypt
- Recruiting
- Ahmed ElMelhat [aelmelhat]
-
Contact:
- Ahmed E [Elmelhat]
- Phone Number: 01112595022
- Email: ahmed.elmelhat@cu.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Older than 18 years old and younger than 70 years old, and referred by the Adult Orthopedic Department with arthroscopic RC repair of a non-retracted isolated full-thickness supraspinatus tear with maximum 5 days post operation.
- Poor response to initial non-operative treatment.
Exclusion Criteria:
- Large-sized RC tears (3-5 cm),
- Massive or irreparable RC tears,
- Anteroinferior labral (Bankart) or superior labrum anterior to posterior lesions,
- Severe glenohumeral osteoarthritis,
- Adhesive capsulitis, or
- Previous surgery on the affected shoulder
- Re-tears of the RC.
- Indication for revision RCR
- Severe neurological deficits
- Infection in the affected shoulder
- Blindness and/or illiteracy
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: Conventional physical therapy
The conventional therapy rehabilitation program is divided into three phases: on-brace, off-brace, and active mobilization.
The on-brace phase (post-op 0-6 weeks) mainly consists of low-intensity whole-body exercises with shoulder girdle, elbow, and hand mobilization exercises on the affected side.
In this phase, exercises are done of three sets with 10 repetitions per day.
The off-brace phase (post-op 6-9 weeks) consists of passive shoulder ROM exercises using an exercise stick and an early scapular stabilization exercise.
The active mobilization phase (post-op 9-12 weeks) consists of both active and passive shoulder ROM , strengthening exercise with progressive resistance using TheraBand, and scapular stabilization exercises.
During the off-brace and active mobilization phases, exercises are done of 3-5 sets of exercises with 10 repetitions per day.
|
conventional therapy rehabilitation program is divided into three phases: on-brace, off-brace, and active mobilization.
The on-brace phase (post-op 0-6 weeks) mainly consists of low-intensity whole-body exercises with shoulder girdle, elbow, and hand mobilization exercises on the affected side.
The off-brace phase (post-op 6-9 weeks) consists of passive shoulder ROM exercises using an exercise stick and an early scapular stabilization exercise.
The active mobilization phase (post-op 9-12 weeks) consists of both active and passive shoulder ROM , strengthening exercise with progressive resistance, and scapular stabilization exercises.
The intervention is done 3 times per week for 12 weeks.
|
Experimental: Virtual reality (VR)
During the on-brace phase(0-6 weeks), participants in this group will use the program as performed in the control group.
During the off-brace (6-9 weeks post-op) and active mobilization phases (9-12 weeks post-op), participants will use the Virtual Reality machine.
This program includes warming and cooling periods with posterior, anterior and inferior capsule stretching and pectoral muscle stretching.
Exercise training includes bilateral shoulder elevation, boxing, bowling and tennis games accompanied by avatar.
Resistance training is progressed in the active mobilization phase using TheraBand.
|
During the on-brace phase (0-6 weeks), participants in this group will use the program as performed in the control group.
During the off-brace (6-9 weeks post-op) and active mobilization phases (9-12 weeks post-op), participants will use the Virtual Reality machine.
this program involves warming up and down stretching exercises and exercise training that includes bilateral shoulder elevation, boxing, bowling and tennis games accompanied by avatar.
The intervention is done 3 times per week for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Shoulder function with disabilities of arm, shoulder and hand
Time Frame: Measured at baseline, after 6 weeks, and after 12 weeks
|
in numbers, it ranges from 0 to 100 with 0 being the lowest and 100 the highest.
The higher the score means the better outcome
|
Measured at baseline, after 6 weeks, and after 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Numerical Pain Intensity Rating Scale
Time Frame: Measured at baseline, after 6 weeks, and after 12 weeks
|
in numbers, it ranges from 0 to 10 with 0 being the lowest and 10 being the highest.
The higher the score means the better outcome
|
Measured at baseline, after 6 weeks, and after 12 weeks
|
Active and passive range of motion using goniometer
Time Frame: Measured at baseline, after 6 weeks, and after 12 weeks
|
in degrees
|
Measured at baseline, after 6 weeks, and after 12 weeks
|
Isometric muscle test by Handheld Dynamometer
Time Frame: Measured at baseline, after 6 weeks, and after 12 weeks
|
in numbers, it ranges from 0 to 5 with 0 being the lowest and 5 the highest.
The higher the score means the better outcome
|
Measured at baseline, after 6 weeks, and after 12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ahmed El Melhat, PhD, Cairo University
Publications and helpful links
General Publications
- Gutierrez-Espinoza H, Araya-Quintanilla F, Pinto-Concha S, Zavala-Gonzalez J, Gana-Hervias G, Cavero-Redondo I, Alvarez-Bueno C. Effectiveness of supervised early exercise program in patients with arthroscopic rotator cuff repair: Study protocol clinical trial. Medicine (Baltimore). 2020 Jan;99(4):e18846. doi: 10.1097/MD.0000000000018846.
- Correia FD, Molinos M, Luis S, Carvalho D, Carvalho C, Costa P, Seabra R, Francisco G, Bento V, Lains J. Digitally Assisted Versus Conventional Home-Based Rehabilitation After Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Mar 1;101(3):237-249. doi: 10.1097/PHM.0000000000001780.
Helpful Links
- Post-operative rehabilitation using a digital healthcare system in patients who had undergone rotator cuff repair: protocol for a single-center randomized controlled trial
- A randomized controlled trial of postoperative rehabilitation using digital healthcare system after rotator cuff repair
- Comparison of virtual reality exergaming and home exercise programs in patients with subacromial impingement syndrome and scapular dyskinesis: Short term effect
- The Effects of Virtual Reality Exergaming on Pain, Functionality and Acromiohumeral Distance in Shoulder Impingement Syndrome Patients: A Randomized Controlled Study
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 (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VR on rotator cuff repair
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.
Clinical Trials on Rotator Cuff Injuries
-
The Cleveland ClinicRecruitingRotator Cuff Tears | Rotator Cuff RepairsUnited States
-
Bezmialem Vakif UniversityNot yet recruitingRotator Cuff Tears | Partial Tear of Rotator CuffTurkey
-
Xiros LtdNot yet recruitingRotator Cuff Tear | Rotator Cuff Injuries | Rotator Cuff Tears | Rotator Cuff Tears of the Shoulder
-
Spital Thurgau AGRecruiting
-
CONMED CorporationRecruitingRotator Cuff TearsUnited States
-
The University of Texas Health Science Center,...Skye BiologicsNot yet recruiting
-
Peking University Third HospitalRecruiting
-
Kaohsiung Veterans General Hospital.Recruiting
-
University of CalgaryRecruiting
-
Seoul National University Bundang HospitalMinistry of Health, Republic of KoreaRecruitingRotator Cuff TearsKorea, Republic of
Clinical Trials on conventional physical therapy training
-
University of LahoreCompletedDiabetic NeuropathiesPakistan
-
St George's, University of LondonThe Health FoundationCompleted
-
October 6 UniversityUnknown
-
Riphah International UniversityCompleted
-
Children's Hospital of PhiladelphiaCompleted
-
Cairo UniversityCompletedDiplegic Cerebral PalsyEgypt
-
Riphah International UniversityCompletedGuillain-Barre SyndromePakistan
-
Cairo UniversityRecruiting
-
Cairo UniversityCompleted
-
Cairo UniversityCompletedSports Physical TherapyEgypt