Knee OsteoarthritisREHABITICNCT01604174
Interactive Virtual Telerehabilitation After Total Knee Arthroplasty
A study testing Interactive Virtual Telerehabilitation (IVT) in people with Knee Osteoarthritis, run by Parc de Salut Mar at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Interactive Virtual Telerehabilitation (IVT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2008to Dec 2010
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of an Interactive Virtual Telerehabilitation System in Patients After Total Knee Arthroplasty. A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Interactive Virtual Telerehabilitation (IVT), Standard care rehabilitation
- Keywords
- knee, osteoarthritis, arthroplasty, rehabilitation
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Virtual Telerehabilitation (IVT)Other
Also called Rehabilitation procedure (physical manipulation) plus IVT
Rehabilitation after arthroplasty of knee using IVT
Standard care rehabilitationOther
Also called Rehabilitation procedure (physical manipulation)
Standard care rehabilitation after total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Interactive Virtual Telerehabilitation | Experimental | Rehabilitation by IVT Receives: Other: Interactive Virtual Telerehabilitation (IVT) |
| Standard rehabilitation care | Active comparator | Standard care rehabilitation after total knee arthroplasty Receives: Other: Standard care rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active knee extension/flexion
Active knee extension/flexion measured by investigator
Measured: Change from baseline to 2 weeks
Secondary outcomes (3)
Muscle strength
Measure of muscle stregth by investigator. That include measures of strength of the quadriceps, Harmstring muscle strength and Timed Getr-UP-ang-Go test
Measured: Baseline to 2 weeks
Pain
Measure of pain by visual analog scales
Measured: Baseline to 2 weeks
Functional capacity
Measure of functional capacity using questionnaires /Western Ontario and MacMaster University)
Measured: Baseline to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startNov 2008
- Primary completionNov 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose M Muniesa, MD, PhD, Principal investigator, Parc de Salut MarFerran Escalada, Md, PhD, Study director, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604174
- Sponsor's protocol ID
- REHABITIC
- Acronym
- REHABITIC
- Status last verified
- May 2012
- First submitted
- 21 May 2012
- Last updated
- 24 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Interactive Virtual Telerehabilitation System in Patients After Total Knee Arthroplasty. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01604174
- Acronym / sponsor ID
- REHABITIC / REHABITIC
- Conditions
- Knee Osteoarthritis
- Keywords
- knee, osteoarthritis, arthroplasty, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 23 May 2012 (estimated)
- 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.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive Virtual Telerehabilitation | Experimental | Other: Interactive Virtual Telerehabilitation (IVT)Rehabilitation by IVT |
| Standard rehabilitation care | Active comparator | Other: Standard care rehabilitationStandard care rehabilitation after total knee arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Interactive Virtual Telerehabilitation (IVT)Also: Rehabilitation procedure (physical manipulation) plus IVTRehabilitation after arthroplasty of knee using IVT | Other | Interactive Virtual Telerehabilitation |
| Standard care rehabilitationAlso: Rehabilitation procedure (physical manipulation)Standard care rehabilitation after total knee arthroplasty | Other | Standard rehabilitation care |
Primary outcome
Active knee extension/flexion
Time frame: Change from baseline to 2 weeks
Active knee extension/flexion measured by investigator
3 secondary outcomes
Muscle strength
Time frame: Baseline to 2 weeks
Pain
Time frame: Baseline to 2 weeks
Functional capacity
Time frame: Baseline to 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2012.
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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.
Jose M Muniesa, MD, PhD principal investigator
Parc de Salut Mar
Ferran Escalada, Md, PhD study director
Parc de Salut Mar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Virtual Telerehabilitation (IVT) in people with Knee Osteoarthritis, run by Parc de Salut Mar at 1 site in Spain.
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 4 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: finished, as of the sponsor's last update on 24 May 2012. 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 Spain. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Active knee extension/flexion (time frame: Change from baseline to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2012.