Rotator Cuff TearNCT03648047
Digital Biofeedback System Versus Conventional Rehabilitation After Rotator Cuff Repair
A study testing Digital kinematic biofeedback device, Conventional rehabilitation and Additional face-to-face rehabilitation sessions in people with Rotator Cuff Tear, run by Sword Health, SA at 1 site in Portugal.
Trial summary
This study was designed to compare the clinical outcomes of a mixed home-based rehabilitation program after arthroscopic rotator cuff repair, incorporating face-to-face sessions as well as sessions performed with a novel digital kinematic biofeedback system against conventional in-person home-based rehabilitation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Digital kinematic biofeedback device, Conventional rehabilitation and Additional face-to-face rehabilitation sessions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePortugal
- Study dates
- 11 Nov 2018to 1 Apr 2020
- 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
- Shoulder pain and functional limitation with clinical examination compatible with rotator cuff tendinopathy
- Imaging (MRI or ultrasound) evidence of rotator cuff tear (supra and/or infraspinatus tendon tear inferior to 3 cm? or 5cm?)
- Indication for a simple rotator cuff repair according to the patient´s orthopedic surgeon
- Ability to understand simple and complex motor commands
- Availability of a carer to assist the patient after surgery
Who cannot join
- Patients admitted for revision cuff repair
- Complex cuff tears (involving subscapularis tendon or more than one tendon besides supra and infraspinatus, or massive dimension tears)
- Glenohumeral arthritis
- Irreparable tendon defect
- Patients with concomitant neurological disorders (ex. Stroke, Parkinson´s disease, multiple sclerosis)
- Aphasia, dementia or psychiatric comorbidity interfering with the communication or compliance to the rehabilitation process
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- Respiratory, cardiac, metabolic conditions or others incompatible with at least 30 minutes of light to moderate physical activity
- Major medical complications occurring after surgery that prevent the discharge of the patient within 10 days after surgery
- Other medical and/or surgical complications that prevent the patient from complying with a rehabilitation program
- Blind and/or illiterate patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Digital Kinematic Biofeedback System for Rehabilitation After Arthroscopic Rotator Cuff Repair Versus Conventional In-person Rehabilitation: a Randomized Controlled Study
This study was designed to compare the clinical outcomes of a mixed home-based rehabilitation program after arthroscopic rotator cuff repair, incorporating face-to-face sessions as well as sessions performed with a novel digital kinematic biofeedback system against conventional in-person home-based rehabilitation, with the intent of reducing the need for face-to-face sessions.
The investigators hypothesize that the clinical outcomes of such a program will be at least similar to those of conventional rehabilitation.
Read more
Patients will be enrolled pre-operatively and then randomized into 2 groups: experimental group and conventional rehabilitation group. Both groups will perform a 12 to 16-week rehabilitation program starting immediately after surgery.
Outcomes will be measured at baseline, 8 and 12 weeks. In patients where a decision is made to extend the program to 16 weeks, another assessment will be made at this point.
- Conditions
- Rotator Cuff Tear
- Being tested
- Digital kinematic biofeedback device, Conventional rehabilitation, Additional face-to-face rehabilitation sessions
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital kinematic biofeedback deviceDevice
Also called SWORD Phoenix
The system will be used independently by the patients to perform rehabilitation sessions at home, under remote monitoring from the clinical team.
Conventional rehabilitationOther
Patients will receive conventional face-to-face sessions by a Physical Therapist.
Additional face-to-face rehabilitation sessionsOther
Patients will receive face-to-face sessions in addition to sessions performed with the Digital Rehabilitation Device
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients in this group will receive a mixed home-based rehabilitation program consisting of face-to-face sessions with a Physical Therapist (with decreasing periodicity depending on program stage) as well as sessions performed with a digital kinematic biofeedback system. Receives: Device: Digital kinematic biofeedback device; Other: Additional face-to-face rehabilitation sessions |
| Conventional rehabilitation | Active comparator | Patients in this group will receive a home-based rehabilitation program consisting of face-to-face sessions with a Physical Therapist 3 times per week, for 1 hour. Patients will also be instructed to perform additional unsupervised sessions in at least two other days of the week. Compliance to these additional sessions is not mandatory, but patients will be asked to fill in a diary regarding these extra-sessions. Receives: Other: Conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Constant Score Test
The Constant Score is a functional assessment score specific to the shoulder region. It is the most used instrument to assess the shoulder in Europe and its psychometric properties prove it to be a valid, reliable and responsive measure.
Measured: Baseline, 8 weeks after surgery, 12 (and 16) weeks.
Secondary outcomes (2)
Change in QuickDASH score
The QuickDASH is an 11-item self-administered outcome measure, specific to measure disability and symptoms in individuals with musculoskeletal disorders of the upper limb.It is an instrument widely used for clinical or research purposes and which has proven to be a valid, reliable and responsive measure.
Measured: Baseline, 8 weeks after surgery, 12 (and16) weeks.
Change in Shoulder Range of Motion
Shoulder range of motion (in degrees) in the following exercises: sitting external rotation/abduction/flexion; lying internal/external rotation with 90º shoulder abduction
Measured: Baseline, 8 weeks after surgery, 12 (and16) weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start11 Nov 2018
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Why it stopped: COVID-19 pandemic imposed restrictions to normal study conduct
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sword Health, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital da Prelada
- Responsible party
- Sponsor
- Investigators
- Fernando D Correia, MD, Principal investigator, SWORD HealthRosmaninho Seabra, MD, Study chair, Hospital da Prelada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648047
- Sponsor's protocol ID
- SH-RCT-ARCR-01
- Status last verified
- Aug 2020
- First submitted
- 23 Aug 2018
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and study aggregate results (including anonymised individual patient data) will be made available
Publications
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.
PubMed 33935152
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Digital Kinematic Biofeedback System for Rehabilitation After Arthroscopic Rotator Cuff Repair Versus Conventional In-person Rehabilitation: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03648047
- Acronym / sponsor ID
- SH-RCT-ARCR-01
- Conditions
- Rotator Cuff Tear
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic imposed restrictions to normal study conduct
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sword Health, SAIndustry (pharma, biotech, devices)
- Collaborators
- Hospital da Prelada
- Study start
- 11 Nov 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 27 Aug 2018 (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 study was designed to compare the clinical outcomes of a mixed home-based rehabilitation program after arthroscopic rotator cuff repair, incorporating face-to-face sessions as well as sessions performed with a novel digital kinematic biofeedback system against conventional in-person home-based rehabilitation, with the intent of reducing the need for face-to-face sessions.
The investigators hypothesize that the clinical outcomes of such a program will be at least similar to those of conventional rehabilitation.
Patients will be enrolled pre-operatively and then randomized into 2 groups: experimental group and conventional rehabilitation group. Both groups will perform a 12 to 16-week rehabilitation program starting immediately after surgery.
Outcomes will be measured at baseline, 8 and 12 weeks. In patients where a decision is made to extend the program to 16 weeks, another assessment will be made at this point.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Digital kinematic biofeedback device, Other: Additional face-to-face rehabilitation sessionsPatients in this group will receive a mixed home-based rehabilitation program consisting of face-to-face sessions with a Physical Therapist (with decreasing periodicity depending on program stage) as well as sessions performed with a digital kinematic biofeedback system. |
| Conventional rehabilitation | Active comparator | Other: Conventional rehabilitationPatients in this group will receive a home-based rehabilitation program consisting of face-to-face sessions with a Physical Therapist 3 times per week, for 1 hour. Patients will also be instructed to perform additional unsupervised sessions in at least two other days of the week. Compliance to these additional sessions is not mandatory, but patients will be asked to fill in a diary regarding these extra-sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Shoulder pain and functional limitation with clinical examination compatible with rotator cuff tendinopathy
- Imaging (MRI or ultrasound) evidence of rotator cuff tear (supra and/or infraspinatus tendon tear inferior to 3 cm? or 5cm?)
- Indication for a simple rotator cuff repair according to the patient´s orthopedic surgeon
- Ability to understand simple and complex motor commands
- Availability of a carer to assist the patient after surgery
Key exclusion criteria (10 listed)
- Patients admitted for revision cuff repair
- Complex cuff tears (involving subscapularis tendon or more than one tendon besides supra and infraspinatus, or massive dimension tears)
- Glenohumeral arthritis
- Irreparable tendon defect
- Patients with concomitant neurological disorders (ex. Stroke, Parkinson´s disease, multiple sclerosis)
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 |
|---|---|---|
| Digital kinematic biofeedback deviceAlso: SWORD PhoenixThe system will be used independently by the patients to perform rehabilitation sessions at home, under remote monitoring from the clinical team. | Device | Experimental group |
| Conventional rehabilitationPatients will receive conventional face-to-face sessions by a Physical Therapist. | Other | Conventional rehabilitation |
| Additional face-to-face rehabilitation sessionsPatients will receive face-to-face sessions in addition to sessions performed with the Digital Rehabilitation Device | Other | Experimental group |
Primary outcome
Change in Constant Score Test
Time frame: Baseline, 8 weeks after surgery, 12 (and 16) weeks.
The Constant Score is a functional assessment score specific to the shoulder region. It is the most used instrument to assess the shoulder in Europe and its psychometric properties prove it to be a valid, reliable and responsive measure.
2 secondary outcomes
Change in QuickDASH score
Time frame: Baseline, 8 weeks after surgery, 12 (and16) weeks.
Change in Shoulder Range of Motion
Time frame: Baseline, 8 weeks after surgery, 12 (and16) weeks.
Results and safety
The study was stopped early (reason given: COVID-19 pandemic imposed restrictions to normal study conduct). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- Derived from this study: 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.
- Individual participant dataSharing planned: Yes. Study protocol and study aggregate results (including anonymised individual patient data) will be made available
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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.
Fernando D Correia, MD principal investigator
SWORD Health
Rosmaninho Seabra, MD study chair
Hospital da Prelada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital kinematic biofeedback device, Conventional rehabilitation and Additional face-to-face rehabilitation sessions in people with Rotator Cuff Tear, run by Sword Health, SA at 1 site in Portugal.
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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 1 Sep 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 Portugal. 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 was stopped early (reason given: COVID-19 pandemic imposed restrictions to normal study conduct). Results are not available in the source record.
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 in Constant Score Test (time frame: Baseline, 8 weeks after surgery, 12 (and 16) 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 NCT03648047, which also lists 1 linked publication.
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 1 Sep 2020.