Interactive Virtual Telerehabilitation After Total Knee Arthroplasty
REHABITIC
Effectiveness of an Interactive Virtual Telerehabilitation System in Patients After Total Knee Arthroplasty. A Randomized Controlled Trial
1 other identifier
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable knee-osteoarthritis
Started Nov 2008
Typical duration for not_applicable knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 21, 2012
CompletedFirst Posted
Study publicly available on registry
May 23, 2012
CompletedMay 24, 2012
May 1, 2012
1 year
May 21, 2012
May 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Active knee extension/flexion
Active knee extension/flexion measured by investigator
Change from baseline to 2 weeks
Secondary Outcomes (3)
Muscle strength
Baseline to 2 weeks
Pain
Baseline to 2 weeks
Functional capacity
Baseline to 2 weeks
Study Arms (2)
Interactive Virtual Telerehabilitation
EXPERIMENTALRehabilitation by IVT
Standard rehabilitation care
ACTIVE COMPARATORStandard care rehabilitation after total knee arthroplasty
Interventions
Rehabilitation after arthroplasty of knee using IVT
Standard care rehabilitation after total knee arthroplasty
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital del Mar (PSMAR)
Barcelona, Barcelona, 08003, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jose M Muniesa, MD, PhD
Parc de Salut Mar
- STUDY DIRECTOR
Ferran Escalada, Md, PhD
Parc de Salut Mar
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2012
First Posted
May 23, 2012
Study Start
November 1, 2008
Primary Completion
November 1, 2009
Study Completion
December 1, 2010
Last Updated
May 24, 2012
Record last verified: 2012-05