Rotator Cuff RepairNCT04374331
Effect of Video-Assisted Training on Upper Extremity Problems and Functions in Patients Undergoing Rotator Cuff Repair
A study testing video-assisted training in people with Rotator Cuff Repair, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial evaluates the effect of video-assisted training (VAT) on upper extremity problems and functions in rotator cuff repair (RCR) patients. The hypothesis of this study is that VAT decreases upper extremity problems and increases functions after RCR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Repair
- What is being tested?
- video-assisted training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2017to 28 Nov 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- underwent elective RCR for the first time;
- whose arm was suspended and fixed for up to three weeks after RCR;
- had an SMMT score of ≥23 points;
Who cannot join
- had been diagnosed with a psychiatric illness;
- have any history of an upper extremity fracture or a rheumatologic disease;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Video-Assisted Training on Upper Extremity Problems and Functions in Patients Undergoing Rotator Cuff Repair: A Randomized Controlled Trial
This randomized controlled trial evaluates the effect of video-assisted training (VAT) on upper extremity problems and functions in rotator cuff repair (RCR) patients. The hypothesis of this study is that VAT decreases upper extremity problems and increases functions after RCR.
Read the detailed description
Methods: Forty-eight elective RCR patients were randomly assigned to VAT and control groups. VAT group (n=24) received VAT including early post-operative care for RCR, activities of daily living (ADL) and gradual exercise program while control group (n=24) received routine care. Primary outcomes were upper extremity problems and functions, assessed using Disabilities of the Arm, Shoulder and Hand (DASH) and Modified Constant-Murley (MCM) scores. Secondary outcomes were complications within three months. Outcomes were collected at baseline, after six weeks and three months.
- Conditions
- Rotator Cuff Repair
- Being tested
- video-assisted training
- Keywords
- Rotator cuff repair, video-assisted training, upper extremity problems, upper extremity functions, complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video-assisted trainingOther
Also called Control group
The patients in the VAT group watch a training video in the patient rooms before RCR. The VAT prepared by the researchers consisted of information about things to pay attention to in the hospital in the early period after RCR (nursing care on post-operative day 1, early mobilization, pain control, shoulder protection, and wearing/removing the shoulder sling), maintaining ADL at home (bathing, nutrition, eating, sleeping position, driving, doing household chores, sexual life, worship, and safety measures to be taken at home) and gradual exercise programs (for the first 90 days after discharge).
| Study group | Role | What they receive |
|---|---|---|
| Video-Assisted Training Group | Experimental | The patients in the VAT group watch a training video in the patient rooms before RCR in addition to the routine treatment and care in the unit. Receives: Other: video-assisted training |
| control group | No intervention | The control group received the routine treatment and care in the unit. The routine treatment and care of the unit includes verbal briefing by physicians and nurses about the surgical procedure before RCR, cold application and analgesic application for pain control after RCR, using arm sling, verbal discharge training (e.g., drug use, exercises, follow-up time, etc.) and discharge on the first post-operative day in the absence of complications. In addition, patients are invited to weekly controls to explain how to do the exercises and, if necessary, they are referred to physiotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change upper extremity problems
The patients' upper extremity problems were assessed using the Disabilities of the Arm, Shoulder and Hand. The possible scores on each part of the questionnaire range from 0 to 100, with higher scores indicating a higher disability level of patients (0=no disability, 100=maximum disability)
Measured: Change from baseline the Disabilities of the Arm, Shoulder and Hand score at 3 months
Change upper extremity functions
The patients' upper extremity functions were assessed using the Modified Constant-Murley score. The Modified Constant-Murley score consists of 100 points in total: 15 points for pain, 20 points for daily of living activities, 40 points for movement and 25 points for strength. The maximum MCM score is 100 points, with higher scores indicating better shoulder functions
Measured: Change from baseline the Modified Constant-Murley score at 3 months
Secondary outcomes (1)
Change of complications
Determine complications after rotator cuff repair
Measured: 1st and 3rd months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start1 Sep 2017
- Primary completion28 Nov 2018
- Study completion28 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff RepairStudies of the same condition, open and under way.
- More trials run by Mersin 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, parallel, two arm, randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulay ALTUN UGRAS, Mersin University
- Investigators
- Gulay Altun Ugras, PhD, Study director, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374331
- Sponsor's protocol ID
- Gulay Altun
- Status last verified
- May 2020
- First submitted
- 29 Apr 2020
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Video-Assisted Training on Upper Extremity Problems and Functions in Patients Undergoing Rotator Cuff Repair: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04374331
- Acronym / sponsor ID
- Gulay Altun
- Conditions
- Rotator Cuff Repair
- Keywords
- Rotator cuff repair, video-assisted training, upper extremity problems, upper extremity functions, complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 28 Nov 2018 (actual)
- Study completion
- 28 Nov 2018 (actual)
- First posted
- 5 May 2020 (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.
This randomized controlled trial evaluates the effect of video-assisted training (VAT) on upper extremity problems and functions in rotator cuff repair (RCR) patients. The hypothesis of this study is that VAT decreases upper extremity problems and increases functions after RCR.
Detailed description
Methods: Forty-eight elective RCR patients were randomly assigned to VAT and control groups. VAT group (n=24) received VAT including early post-operative care for RCR, activities of daily living (ADL) and gradual exercise program while control group (n=24) received routine care. Primary outcomes were upper extremity problems and functions, assessed using Disabilities of the Arm, Shoulder and Hand (DASH) and Modified Constant-Murley (MCM) scores. Secondary outcomes were complications within three months. Outcomes were collected at baseline, after six weeks and three months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- prospective, parallel, two arm, randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Video-Assisted Training Group | Experimental | Other: video-assisted trainingThe patients in the VAT group watch a training video in the patient rooms before RCR in addition to the routine treatment and care in the unit. |
| control group | No intervention | –The control group received the routine treatment and care in the unit. The routine treatment and care of the unit includes verbal briefing by physicians and nurses about the surgical procedure before RCR, cold application and analgesic application for pain control after RCR, using arm sling, verbal discharge training (e.g., drug use, exercises, follow-up time, etc.) and discharge on the first post-operative day in the absence of complications. In addition, patients are invited to weekly controls to explain how to do the exercises and, if necessary, they are referred to physiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- underwent elective RCR for the first time;
- whose arm was suspended and fixed for up to three weeks after RCR;
- had an SMMT score of ≥23 points;
Key exclusion criteria (2 listed)
- had been diagnosed with a psychiatric illness;
- have any history of an upper extremity fracture or a rheumatologic disease;
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 |
|---|---|---|
| video-assisted trainingAlso: Control groupThe patients in the VAT group watch a training video in the patient rooms before RCR. The VAT prepared by the researchers consisted of information about things to pay attention to in the hospital in the early period after RCR (nursing care on post-operative day 1, early mobilization, pain control, shoulder protection, and wearing/removing the shoulder sling), maintaining ADL at home (bathing, nutrition, eating, sleeping position, driving, doing household chores, sexual life, worship, and safety measures to be taken at home) and gradual exercise programs (for the first 90 days after discharge). | Other | Video-Assisted Training Group |
Primary outcome
Change upper extremity problems
Time frame: Change from baseline the Disabilities of the Arm, Shoulder and Hand score at 3 months
The patients' upper extremity problems were assessed using the Disabilities of the Arm, Shoulder and Hand. The possible scores on each part of the questionnaire range from 0 to 100, with higher scores indicating a higher disability level of patients (0=no disability, 100=maximum disability)
Change upper extremity functions
Time frame: Change from baseline the Modified Constant-Murley score at 3 months
The patients' upper extremity functions were assessed using the Modified Constant-Murley score. The Modified Constant-Murley score consists of 100 points in total: 15 points for pain, 20 points for daily of living activities, 40 points for movement and 25 points for strength. The maximum MCM score is 100 points, with higher scores indicating better shoulder functions
1 secondary outcome
Change of complications
Time frame: 1st and 3rd months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
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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.
Gulay Altun Ugras, PhD study director
Mersin 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 video-assisted training in people with Rotator Cuff Repair, run by Mersin University at 1 site in Turkey (Türkiye).
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 7 May 2020. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change upper extremity problems (time frame: Change from baseline the Disabilities of the Arm, Shoulder and Hand score at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2020.