Rotator Cuff Impingement SyndromeNCT06246305
Effect of Virtual Reality on Upper Extremity Function Post-operative Rotator Cuff Repair
A study testing conventional physical therapy training and Virtual Reality (VR) training in people with Rotator Cuff Impingement Syndrome and Rotator Cuff Tears, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Rotator Cuff Impingement Syndrome, Rotator Cuff Tears, Rotator Cuff Injuries
- What is being tested?
- conventional physical therapy training and Virtual Reality (VR) training
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Jan 2024to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- Re-tears of the RC.
- Indication for revision RCR
- Severe neurological deficits
- Infection in the affected shoulder
- Blindness and/or illiteracy
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed ElMelhat [aelmelhat]
Cairo
Ahmed E [Elmelhat], 01112595022, ahmed.elmelhat@cu.edu.eg
About this study
Official title: 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.
Read the detailed description
Rotator cuff tears are one of the most common disorders of the shoulder that result in shoulder pain and dysfunction. It affects about 30% of individuals that are older than 60 years. The conservative management is the first-line treatment for a rotator cuff tear, but a surgical rotator cuff repair (RCR) is required if the conservative management failed. Post-operative rehabilitation requires up to 12 weeks. But, Virtual Reality (VR) intervention is emerging as a viable alternative for musculoskeletal rehabilitation of the upper limb. Unlike in neuro-rehabilitation, VR is still poorly used in orthopedic rehabilitation. Thus, the investigators hypothesize that performing virtual reality intervention will improve the upper extremity function in patients with post-operative rotator cuff repair.
- Being tested
- conventional physical therapy training, Virtual Reality (VR) training
- Keywords
- rotator cuff repair, post-operative, upper extremity, function
- Medical subject headings
- Shoulder Impingement Syndrome, Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional physical therapy trainingOther
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.
Virtual Reality (VR) trainingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional physical therapy | Active comparator | 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. Receives: Other: conventional physical therapy training |
| Virtual reality (VR) | Experimental | 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. Receives: Device: Virtual Reality (VR) training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder function with disabilities of arm, shoulder and hand
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: Measured at baseline, after 6 weeks, and after 12 weeks
Secondary outcomes (3)
The Numerical Pain Intensity Rating Scale
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: Measured at baseline, after 6 weeks, and after 12 weeks
Active and passive range of motion using goniometer
in degrees
Measured: Measured at baseline, after 6 weeks, and after 12 weeks
Isometric muscle test by Handheld Dynamometer
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: Measured at baseline, after 6 weeks, and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start28 Jan 2024
- Primary completionMay 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff Impingement SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into one of the 2 groups: the control group receiving the conventional physical therapy intervention or to the experimental group receiving virtual reality intervention
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed ElMelhat, Cairo University
- Investigators
- Ahmed El Melhat, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246305
- Sponsor's protocol ID
- VR on rotator cuff repair
- Status last verified
- Jan 2024
- First submitted
- 27 Jan 2024
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 31977882Correia 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.
PubMed 33935152
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Intervention and Its Impact on Upper Extremity Function in Patients With Post-operative Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT06246305
- Acronym / sponsor ID
- VR on rotator cuff repair
- Keywords
- rotator cuff repair, post-operative, upper extremity, function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 28 Jan 2024 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rotator cuff tears are one of the most common disorders of the shoulder that result in shoulder pain and dysfunction. It affects about 30% of individuals that are older than 60 years. The conservative management is the first-line treatment for a rotator cuff tear, but a surgical rotator cuff repair (RCR) is required if the conservative management failed. Post-operative rehabilitation requires up to 12 weeks. But, Virtual Reality (VR) intervention is emerging as a viable alternative for musculoskeletal rehabilitation of the upper limb. Unlike in neuro-rehabilitation, VR is still poorly used in orthopedic rehabilitation. Thus, the investigators hypothesize that performing virtual reality intervention will improve the upper extremity function in patients with post-operative rotator cuff repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into one of the 2 groups: the control group receiving the conventional physical therapy intervention or to the experimental group receiving virtual reality intervention
| Arm | Type | Receives |
|---|---|---|
| Conventional physical therapy | Active comparator | Other: conventional physical therapy trainingThe 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. |
| Virtual reality (VR) | Experimental | Device: Virtual Reality (VR) trainingDuring 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. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional physical therapy trainingconventional 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. | Other | Conventional physical therapy |
| Virtual Reality (VR) trainingDuring 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. | Device | Virtual reality (VR) |
Primary outcome
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
3 secondary outcomes
The Numerical Pain Intensity Rating Scale
Time frame: 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
Isometric muscle test by Handheld Dynamometer
Time frame: Measured at baseline, after 6 weeks, and after 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Background: PubMed 31977882Gutierrez-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.
- Background: PubMed 33935152Correia 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.
- Post-operative rehabilitation using a digital healthcare system in patients who had undergone rotator cuff repair: protocol for a single-center randomized controlled trialLink provided by the sponsor.
- A randomized controlled trial of postoperative rehabilitation using digital healthcare system after rotator cuff repairLink provided by the sponsor.
- Comparison of virtual reality exergaming and home exercise programs in patients with subacromial impingement syndrome and scapular dyskinesis: Short term effectLink provided by the sponsor.
- The Effects of Virtual Reality Exergaming on Pain, Functionality and Acromiohumeral Distance in Shoulder Impingement Syndrome Patients: A Randomized Controlled StudyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed El Melhat, PhD study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional physical therapy training and Virtual Reality (VR) training in people with Rotator Cuff Impingement Syndrome and Rotator Cuff Tears, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed El Melhat, PhD (01112595022, ahmed.elmelhat@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder function with disabilities of arm, shoulder and hand (time frame: Measured at baseline, after 6 weeks, and after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06246305, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024; AzTrials last refreshed its copy on 27 Oct 2026.