Proprioceptive DisordersPro-kneeNCT04885725
Association Between Knee Isokinetic Testing and Lower Limb Functional Performance and Limb Symmetry
An observational study of Proprioceptive Disorders, run by University Hospital, Caen at 1 site in France.
Trial summary
This study aimed to evaluate the association between the isokinetic knee strength and/or proprioception performance with the functional performance on the functional Hop-tests and Y-balance test. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Proprioceptive Disorders
- What is being tested?
- All group
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 5 Dec 2019to 26 Sep 2020
- Phase
- Observational
- 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 Any age
- Child, Adult, Older adult
Study population: Young healthy adults who volunteered to participate in this study
Who may be able to join
- individuals under 45 years of age who performed at least 4 hours of physical activity per week.
Who cannot join
- individuals unable to perform isokinetic muscle tests
- individuals with a current or recent lower limb injury with time loss from sport participation within the previous month
- individuals with previous severe knee injury (eg. Severe ligament tear, knee fracture)
- individuals taking medications with potential balance/coordination side effects.
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to evaluate the association between the isokinetic knee strength and/or proprioception performance with the functional performance on the functional Hop-tests and Y-balance test.
This study included 20 healthy individuals who performed an isokinetic assessment of knee proprioception (joint position sense, JPS and threshold to detection of passive motion, TDPM) and flexors/extensors strength. At the same time, they performed a functional testing consisting of three Hop-tests (single, triple and cross-over) and the Lower Quarter Y-Balance Test (YBT-LQ). We tested the correlation between the isokinetic and functional performances, and limb symmetry indexes.
- Conditions
- Proprioceptive Disorders
- Being tested
- All group
- Medical subject headings
- Somatosensory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All groupDevice
All the participants performed the isokinetic proprioception and strength tests and the functional tests, on the same visit.
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength
Measurement of knee extensors and flexors peak strength (in newton.meter, Nm) on isokinetic dynamometer.
Measured: one evaluation at a single point in time through study completion, an average of 4 months
Knee proprioception, JPS1
Measurement of knee proprioception by the passive repositioning technique (JPS, in degrees) on isokinetic dynamometer.
Measured: one evaluation at a single point in time through study completion, an average of 4 months
Knee proprioception, JPS2
Measurement of knee proprioception by the active repositioning technique (JPS, in degrees) on isokinetic dynamometer.
Measured: one evaluation at a single point in time through study completion, an average of 4 months
Knee proprioception, TDPM
Measurement of knee proprioception by the Threshold to Detection of Passive Motion (TDPM in degrees) on isokinetic dynamometer.
Measured: one evaluation at a single point in time through study completion, an average of 4 months
Functional testing, Hop tests
Hop test. Single hop: Patients are instructed to stand on one leg and perform 1 jump as far as possible, landing on the same leg.
The total distance is recorded (in cm) .Triple hop: Patients are instructed to stand on one leg and perform 3 hops as far as possible, landing on the same leg.
The total distance for 3 consecutive hops is recorded (in cm). Cross-over hop test : The patient hops forward 3 times while alternately crossing over a marking The patient is instructed to position themselves such that the first of the 3 hops was lateral with respect to the direction of crossover The total distance hopped forward is recorded (in cm)
Measured: one evaluation at a single point in time through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start5 Dec 2019
- Primary completion15 Mar 2020
- Study completion26 Sep 2020
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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joffrey DRIGNY, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885725
- Sponsor's protocol ID
- Pro-knee
- Acronym
- Pro-knee
- Status last verified
- May 2021
- First submitted
- 9 May 2021
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Knee Isokinetic Testing and Lower Limb Functional Performance and Limb Symmetry
- ClinicalTrials.gov ID
- NCT04885725
- Acronym / sponsor ID
- Pro-knee / Pro-knee
- Conditions
- Proprioceptive Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 26 Sep 2020 (actual)
- First posted
- 13 May 2021 (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.
This study aimed to evaluate the association between the isokinetic knee strength and/or proprioception performance with the functional performance on the functional Hop-tests and Y-balance test.
This study included 20 healthy individuals who performed an isokinetic assessment of knee proprioception (joint position sense, JPS and threshold to detection of passive motion, TDPM) and flexors/extensors strength. At the same time, they performed a functional testing consisting of three Hop-tests (single, triple and cross-over) and the Lower Quarter Y-Balance Test (YBT-LQ). We tested the correlation between the isokinetic and functional performances, and limb symmetry indexes.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- Young healthy adults who volunteered to participate in this study
Key inclusion criteria (1 listed)
- individuals under 45 years of age who performed at least 4 hours of physical activity per week.
Key exclusion criteria (4 listed)
- individuals unable to perform isokinetic muscle tests
- individuals with a current or recent lower limb injury with time loss from sport participation within the previous month
- individuals with previous severe knee injury (eg. Severe ligament tear, knee fracture)
- individuals taking medications with potential balance/coordination side effects.
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 |
|---|---|---|
| All groupAll the participants performed the isokinetic proprioception and strength tests and the functional tests, on the same visit. | Device | – |
Primary outcome
Strength
Time frame: one evaluation at a single point in time through study completion, an average of 4 months
Measurement of knee extensors and flexors peak strength (in newton.meter, Nm) on isokinetic dynamometer.
Knee proprioception, JPS1
Time frame: one evaluation at a single point in time through study completion, an average of 4 months
Measurement of knee proprioception by the passive repositioning technique (JPS, in degrees) on isokinetic dynamometer.
Knee proprioception, JPS2
Time frame: one evaluation at a single point in time through study completion, an average of 4 months
Measurement of knee proprioception by the active repositioning technique (JPS, in degrees) on isokinetic dynamometer.
Knee proprioception, TDPM
Time frame: one evaluation at a single point in time through study completion, an average of 4 months
Measurement of knee proprioception by the Threshold to Detection of Passive Motion (TDPM in degrees) on isokinetic dynamometer.
Functional testing, Hop tests
Time frame: one evaluation at a single point in time through study completion, an average of 4 months
Hop test. Single hop: Patients are instructed to stand on one leg and perform 1 jump as far as possible, landing on the same leg. The total distance is recorded (in cm) .Triple hop: Patients are instructed to stand on one leg and perform 3 hops as far as possible, landing on the same leg. The total distance for 3 consecutive hops is recorded (in cm). Cross-over hop test : The patient hops forward 3 times while alternately crossing over a marking The patient is instructed to position themselves such that the first of the 3 hops was lateral with respect to the direction of crossover The total distance hopped forward is recorded (in cm)
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 13 May 2021.
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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?
An observational study of Proprioceptive Disorders, run by University Hospital, Caen at 1 site in France.
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 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 13 May 2021. 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 France. 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?
Strength (time frame: one evaluation at a single point in time through study completion, an average of 4 months). The study lists 5 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 13 May 2021.