Trials / Terminated
TerminatedNCT03648047
Digital Biofeedback System Versus Conventional Rehabilitation After Rotator Cuff Repair
Efficacy of a Digital Kinematic Biofeedback System for Rehabilitation After Arthroscopic Rotator Cuff Repair Versus Conventional In-person Rehabilitation: a Randomized Controlled Study
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Sword Health, SA · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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, 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 | Conventional rehabilitation | Patients will receive conventional face-to-face sessions by a Physical Therapist. |
| OTHER | Additional face-to-face rehabilitation sessions | Patients will receive face-to-face sessions in addition to sessions performed with the Digital Rehabilitation Device |
Timeline
- Start date
- 2018-11-11
- Primary completion
- 2020-04-01
- Completion
- 2020-04-01
- First posted
- 2018-08-27
- Last updated
- 2020-09-01
Locations
1 site across 1 country: Portugal
Source: ClinicalTrials.gov record NCT03648047. Inclusion in this directory is not an endorsement.