Total Knee ReplacementNCT02707419
Action Observation in Knee Replacement
A study testing Experimental group and Conventional physiotherapy in people with Total Knee Replacement, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
Postoperative rehabilitation is required for a successful outcome following total knee arthroplasty. Traditionally rehabilitative programs aim to increase range of motion, to strengthen quadriceps, to restore normal gait, and to recover independence in activities of daily living. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- Experimental group and Conventional physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2014to Oct 2014
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary total knee replacement.
Who cannot join
- bilateral knee replacement
- previous total knee replacement.
- pre-existing motor impairment (i.e. hemiparesis, poliomyelitis, lumbar sciatica);
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-administered Action Observation Treatment Enhance the Efficacy of Inpatient Rehabilitation After Total Knee Replacement: A Randomized Controlled Trial
Postoperative rehabilitation is required for a successful outcome following total knee arthroplasty. Traditionally rehabilitative programs aim to increase range of motion, to strengthen quadriceps, to restore normal gait, and to recover independence in activities of daily living. In the last decade action observation treatment, in addition to conventional physiotherapy has been proposed as a treatment method in rehabilitative medicine. There is growing evidence of the applicability of action observation training in rehabilitative medicine, indeed it has been applied in the rehabilitation of stroke of Parkinson disease of cerebral palsy and of aphasia.
Nevertheless those are small studies and one of them included a mixed population of hip and knee arthroplasty.
- Conditions
- Total Knee Replacement
- Being tested
- Experimental group, Control group, Conventional physiotherapy
- Keywords
- Total knee replacement, Action observation treatment, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupDevice
Video of the exercises
Control groupDevice
video of nature scenes
Conventional physiotherapyDevice
Mobilization, exercises and transfer practice.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Video of the exercises and conventional physiotherapy. 45 minutes twice a day, 5 days a week for 2 weeks. Receives: Device: Experimental group; Device: Conventional physiotherapy |
| Control group | Active comparator | Video of nature scenes and conventional physiotherapy. 45 minutes twice a day, 5 days a week for 2 weeks. Receives: Device: Control group; Device: Conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Pain intensity
Visual Analogue Scale
Measured: Baseline and immediately post-intervention
Change of Range Of Motion
Active and passive range of motion of knee
Measured: Baseline and immediately post-intervention
Secondary outcomes (4)
Barthel index
Barthel index
Measured: Baseline and immediately post-intervention
Short Form-36 motor
Measured: Baseline and immediately post-intervention
Tinetti scale
Measured: Baseline and immediately post-intervention
Lequesne index
Measured: Baseline and immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study startApr 2014
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies 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
- Participant, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Hugo Villafañe, PhD, Fondazione Don Carlo Gnocchi ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707419
- Sponsor's protocol ID
- Dongnocchi
- Status last verified
- Mar 2016
- First submitted
- 27 Feb 2016
- Last updated
- 14 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-administered Action Observation Treatment Enhance the Efficacy of Inpatient Rehabilitation After Total Knee Replacement: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02707419
- Acronym / sponsor ID
- Dongnocchi
- Conditions
- Total Knee Replacement
- Keywords
- Total knee replacement, Action observation treatment, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 14 Mar 2016 (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.
Postoperative rehabilitation is required for a successful outcome following total knee arthroplasty. Traditionally rehabilitative programs aim to increase range of motion, to strengthen quadriceps, to restore normal gait, and to recover independence in activities of daily living. In the last decade action observation treatment, in addition to conventional physiotherapy has been proposed as a treatment method in rehabilitative medicine. There is growing evidence of the applicability of action observation training in rehabilitative medicine, indeed it has been applied in the rehabilitation of stroke of Parkinson disease of cerebral palsy and of aphasia.
Nevertheless those are small studies and one of them included a mixed population of hip and knee arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Experimental group, Device: Conventional physiotherapyVideo of the exercises and conventional physiotherapy. 45 minutes twice a day, 5 days a week for 2 weeks. |
| Control group | Active comparator | Device: Control group, Device: Conventional physiotherapyVideo of nature scenes and conventional physiotherapy. 45 minutes twice a day, 5 days a week for 2 weeks. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary total knee replacement.
Key exclusion criteria (3 listed)
- bilateral knee replacement
- previous total knee replacement.
- pre-existing motor impairment (i.e. hemiparesis, poliomyelitis, lumbar sciatica);
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 |
|---|---|---|
| Experimental groupVideo of the exercises | Device | Experimental group |
| Control groupvideo of nature scenes | Device | Control group |
| Conventional physiotherapyMobilization, exercises and transfer practice. | Device | Control group, Experimental group |
Primary outcome
Change of Pain intensity
Time frame: Baseline and immediately post-intervention
Visual Analogue Scale
Change of Range Of Motion
Time frame: Baseline and immediately post-intervention
Active and passive range of motion of knee
4 secondary outcomes
Barthel index
Time frame: Baseline and immediately post-intervention
Short Form-36 motor
Time frame: Baseline and immediately post-intervention
Tinetti scale
Time frame: Baseline and immediately post-intervention
Lequesne index
Time frame: Baseline and immediately post-intervention
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 14 Mar 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group and Conventional physiotherapy in people with Total Knee Replacement, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
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 1 inclusion and 3 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 14 Mar 2016. 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 Italy. 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?
Change of Pain intensity (time frame: Baseline and immediately post-intervention). The study lists 2 primary outcomes in all. 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 14 Mar 2016.