Proprioceptive DisordersPROPRIO_TPGNCT03837041
Evaluation of Proprioception
A study testing Reconditioning Proprioception in people with Proprioceptive Disorders, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The osteoarthritis (OA) is a chronic and degenerative disease which brings articular cartilage degeneration. As a consequence, balance and proprioception could be dangerously reduced after total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Proprioceptive Disorders
- What is being tested?
- Reconditioning Proprioception
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2017to 31 Dec 2021
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria are patients with ASA: 1, 2 or 3; patients who have given their informed written consent to participate in the study; patients live in Bologna and neighboring areas.
Exclusion Criteria are patients with previous osteotomy of the lower limbs; patients with post-traumatic arthrosis; patients with severe preoperative valgus deformity (Hip Knee Ankle angle> 10 °); patients with BMI> 40 kg / m2; patients with rheumatoid arthritis; patients with chronic inflammatory joint diseases; patients with walking diseases (amputations, neuro-muscular diseases, polio, hip dysplasias); patients with Severe arthrosis of the ankle (Kellgren-Lawrence> 3); patients with Severe coxarthrosis (Kellgren-Lawrence> 3); patients with severe postural instability; patients with cognitive impairments, patients with concomitant neurological diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluate the Proprioception in Patients with Total Knee Arthroplasty
The osteoarthritis (OA) is a chronic and degenerative disease which brings articular cartilage degeneration. As a consequence, balance and proprioception could be dangerously reduced after total knee arthroplasty.
Several studies demonstrated the correlation between OA, proprioception reduction and increased risk of falling. The aim of this study is to evaluate the proprioception improvement in patients with total knee arthroplasty.
- Conditions
- Proprioceptive Disorders
- Being tested
- Reconditioning Proprioception
- Keywords
- total knee arthroplasty, Proprioception, osteoarthritis
- Medical subject headings
- Somatosensory Disorders, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reconditioning ProprioceptionOther
Proprioceptive training using Delos Postural Proprioceptive System
| Study group | Role | What they receive |
|---|---|---|
| Reconditioning Proprioception group | Active comparator | Training Proprioception 1 hour for 2 day a week Receives: Other: Reconditioning Proprioception |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of a proprioception
Stability Index (SI) in percentage the maximum is 100%
Measured: 24 months
Secondary outcomes (3)
Evaluation of performance in lower limb questionnaire
Short Physical Performance Battery - SPPB The score range from 0 (wost performance) to 12 (best performance)
Measured: 24 months
KSS Score
The score range from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions
Measured: 24 months
Clinical score
Western Ontario and McMaster Universities Osteoarthritis Index the WOMAC evaluates 3 dimensions: pain, stiffness, and physical function with 5, 2, and 17 questions, respectively. The Likert version of the WOMAC is rated on an ordinal scale of 0 to 4, with lower scores indicating lower levels of symptoms or physical disability.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start1 Mar 2017
- Primary completion31 Jul 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proprioceptive DisordersStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bologna
- Responsible party
- Principal investigator, Stefano Zaffagnini, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837041
- Sponsor's protocol ID
- PROPRIO_TPG
- Acronym
- PROPRIO_TPG
- Status last verified
- May 2023
- First submitted
- 7 Feb 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Proprioception in Patients with Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03837041
- Acronym / sponsor ID
- PROPRIO_TPG / PROPRIO_TPG
- Conditions
- Proprioceptive Disorders
- Keywords
- total knee arthroplasty, Proprioception, osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Collaborators
- University of Bologna
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 11 Feb 2019 (actual)
- 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 osteoarthritis (OA) is a chronic and degenerative disease which brings articular cartilage degeneration. As a consequence, balance and proprioception could be dangerously reduced after total knee arthroplasty.
Several studies demonstrated the correlation between OA, proprioception reduction and increased risk of falling. The aim of this study is to evaluate the proprioception improvement in patients with total knee arthroplasty.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reconditioning Proprioception group | Active comparator | Other: Reconditioning ProprioceptionTraining Proprioception 1 hour for 2 day a week |
| Control group | No intervention | – |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Reconditioning ProprioceptionProprioceptive training using Delos Postural Proprioceptive System | Other | Reconditioning Proprioception group |
Primary outcome
Improvement of a proprioception
Time frame: 24 months
Stability Index (SI) in percentage the maximum is 100%
3 secondary outcomes
Evaluation of performance in lower limb questionnaire
Time frame: 24 months
KSS Score
Time frame: 24 months
Clinical score
Time frame: 24 months
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 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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 Reconditioning Proprioception in people with Proprioceptive Disorders, run by Istituto Ortopedico Rizzoli 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?
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 19 Sep 2024. 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?
Improvement of a proprioception (time frame: 24 months). 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 19 Sep 2024.