Digital Biofeedback System Versus Conventional Rehabilitation After Rotator Cuff Repair
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|ClinicalTrials.gov Identifier: NCT03648047|
Recruitment Status : Terminated (COVID-19 pandemic imposed restrictions to normal study conduct)
First Posted : August 27, 2018
Last Update Posted : September 1, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Rotator Cuff Tear||Device: Digital kinematic biofeedback device Other: Conventional rehabilitation Other: Additional face-to-face rehabilitation sessions||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||All patients will be assessed by an independent outcomes assessor|
|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|
|Actual Study Start Date :||November 11, 2018|
|Actual Primary Completion Date :||April 1, 2020|
|Actual Study Completion Date :||April 1, 2020|
Experimental: Experimental group
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.
Device: Digital kinematic biofeedback device
The system will be used independently by the patients to perform rehabilitation sessions at home, under remote monitoring from the clinical team.
Other Name: SWORD Phoenix
Other: Additional face-to-face rehabilitation sessions
Patients will receive face-to-face sessions in addition to sessions performed with the Digital Rehabilitation Device
Active Comparator: Conventional rehabilitation
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.
Other: Conventional rehabilitation
Patients will receive conventional face-to-face sessions by a Physical Therapist.
- 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.
- Change in QuickDASH score [ Time Frame: Baseline, 8 weeks after surgery, 12 (and16) weeks. ]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.
- Change in Shoulder Range of Motion [ Time Frame: Baseline, 8 weeks after surgery, 12 (and16) weeks. ]Shoulder range of motion (in degrees) in the following exercises: sitting external rotation/abduction/flexion; lying internal/external rotation with 90º shoulder abduction
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648047
|Hospital da Prelada|
|Porto, Portugal, 4250-449|
|Principal Investigator:||Fernando D Correia, MD||SWORD Health|
|Study Chair:||Rosmaninho Seabra, MD||Hospital da Prelada|