REHABITIC: Interactive Virtual Telerehabilitation After Total Knee Arthroplasty
Study Details
Study Description
Brief Summary
The purpose of this clinical trial is to compare the effectiveness of a new interactive virtual telerehabilitation (IVT) system with the conventional program in the rehabilitation of patients after total knee arthroplasty.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Patients are distributed into two treatment groups: 1) Group I (control): standard clinical protocol of TKA rehabilitation consisting of 1-hour sessions for 10 days; and 2) Group II (IVT): 1-hour IVT sessions for 10 days (5 sessions under a therapist's supervision to verify the absence of medical complications + 5 sessions performed at home). The IVT is an interactive virtual software-hardware platform that facilitates the development of remote rehabilitation therapy for multiple diseases. Patients receive information required to perform exercise and the therapist remotely monitors the patient's performance. For the purpose of this trial, the IVT system was designed for lower limb motor recovery in patients undergoing TKA.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Interactive Virtual Telerehabilitation Rehabilitation by IVT |
Other: Interactive Virtual Telerehabilitation (IVT)
Rehabilitation after arthroplasty of knee using IVT
Other Names:
|
| Active Comparator: Standard rehabilitation care Standard care rehabilitation after total knee arthroplasty |
Other: Standard care rehabilitation
Standard care rehabilitation after total knee arthroplasty
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Active knee extension/flexion [Change from baseline to 2 weeks]
Active knee extension/flexion measured by investigator
Secondary Outcome Measures
- Muscle strength [Baseline to 2 weeks]
Measure of muscle stregth by investigator. That include measures of strength of the quadriceps, Harmstring muscle strength and Timed Getr-UP-ang-Go test
- Pain [Baseline to 2 weeks]
Measure of pain by visual analog scales
- Functional capacity [Baseline to 2 weeks]
Measure of functional capacity using questionnaires /Western Ontario and MacMaster University)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Post-TKA active range of motion: flexion 80º and extension -10º
-
ABsence of stiffness
-
Ability to walk with the use of a walking aid
-
Ability to read and understand Spanish
-
Ability to understand and accept the trial procedures and to sign an informed consent form in accordance with national legislation
Exclusion Criteria:
-
Sensory, cognitive and/or praxic impairment
-
Concomitant medical conditions that may influence the rehabilitation process
-
Discharge destination other than home
-
Patients with any local or systemic complication (e.g., surgical wound infection, suspicion of deep vein thrombosis…) in the three-month follow-up period
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital del Mar (PSMAR) | Barcelona | Spain | 08003 |
Sponsors and Collaborators
- Parc de Salut Mar
Investigators
- Principal Investigator: Jose M Muniesa, MD, PhD, Parc de Salut Mar
- Study Director: Ferran Escalada, Md, PhD, Parc de Salut Mar
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- REHABITIC