Istituto Clinico Humanitas
Rozzano, Milano, 20089, Italy
NCT Number: NCT03997565
Functional recovery after total knee replacement (TKR) is characterized by an incomplete muscle strength due to arthrogenic muscle inhibition (AMI) and tendency to estimate the functional level. These deficits could be related to alteration of sensory feedback, and could influence the ability to modulate patients' motor performance.
To date, there are not studies investigatin the ability to modulate the motor performance in patients with TKR compared to healthy age-matched subjects.
In this study 20 patients with TKR and 20 healthy will be included . Inclusion criteria are: age between 40 and 80 , TKR for primary knee osteoarthritis, knee flexion ≥ 90° and complete knee extension, ability to perform a sit to stand on a 46 cm high chair and to walk for at least 50 meters without aids. Exclusion criteria: patients undergoing TKR after traumas, previous tibial or femoral osteotomy, partial or complete revision surgery. subjects with psychiatric and/or cognitive impairments, or with neurological, musculoskeletal or other disorders that could influence motor or functional recovery will be also exluded.
The aim of the study is to investigate the ability in motor performance modulation in patients after TKR compared to healthy age-mtched subjects.
Primary endpoint is to investigate this ability during a leg extension performed in open kinetic chain. This ability will be also evaluated during a Sit To Stand and during walking (with 10 Meters Walking Test). Secondary endpoint is to investigate pain, rate of perceived exertion and perceived load symmetry during the three tests. In both healthy and TKR groups these outcomes will be detected two times. In particular, in TKR group, patients will be tested the day before surgery and 5 days after surgery.
This study is aimed at conducting a survey in healthy subjects and in a population of subjects undergoing TKR . Participants will undergo an acquisition similar to others already described in the literature and without adverse events. Tests will last about 60 minutes and during them, will be used the equipment of Motion Analysis Lab of "Humanitas Research Hospital".
Looking for future studies?
Notify Me40 year–80 year
All sexes
Observational
Rozzano, Milano, 20089, Italy
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Healthy subjects will have to comply with all the eligibility criteria just mentioned except for the inclusion criterion: Intervention of TKR following primary gonarthrosis
No intervention provided, but investigation of the ability to modulate motor performance during specific and functional tasks in subjects undergoing TKR compared with healthy subjects.
Time frame: Patients will be evaluated the day before (T0) and the fifth day after surgery (T1), whereas healthy subjects will perform two evaluations, the first one at T0 and the second one 5 days after (T1)
Force reproduction error between the PT-target and the PT-observed during knee extension with an isokinetic dynamometer (Ω = 60 °/s)
Time frame: Patients will be evaluated the day before (T0) and the fifth day after surgery (T1), whereas healthy subjects will perform two evaluations, the first one at T0 and the second one 5 days after (T1)
The error between OS-target and OS-observed during Sit-to-Stand using two force platforms.
Time frame: Patients will be evaluated the day before (T0) and the fifth day after surgery (T1), whereas healthy subjects will perform two evaluations, the first one at T0 and the second one 5 days after (T1)
Error between "target speed" and "observed speed" during 10 meters walking test
Time frame: Patients will be evaluated the day before (T0) and the fifth day after surgery (T1), whereas healthy subjects will perform two evaluations, the first one at T0 and the second one 5 days after (T1)
Pain will be assessed with Visual Analogue Scale (VAS 0-10) ranging from 0 (absence of pain) to 10 (maximum pain)
Time frame: Patients will be evaluated the day before (T0) and the fifth day after surgery (T1), whereas healthy subjects will perform two evaluations, the first one at T0 and the second one 5 days after (T1)
Perceived exertion will be assessed with Modified Borg Scale (0-10), ranging from 0 (no exertion) to 10 (maximum exertion)
Time frame: Patients will be evaluated the day before (T0) and the fifth day after surgery (T1), whereas healthy subjects will perform two evaluations, the first one at T0 and the second one 5 days after (T1)
Perceived symmetry of load will be assessed with Visual Analogue Scale (VAS), ranging from -10 (body weight on left limb) to 10 (body weight on right limb). A value of 0 denotes perfect symmetry.
Istituto Clinico Humanitas
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07654309
Neurologic Manifestations, Pain
Dargai, KPK, Pakistan
View Trial DetailsNCT01307202
Neurologic Manifestations, Pain
Hamilton, Ontario, Canada
View Trial DetailsNCT07458321
Intracranial Pressure Change, Optic Nerve Sheath Diameter Measurement
Bursa, Merkez, Turkey (Türkiye)
View Trial DetailsNCT06877845
Neurologic Manifestations, Pain
Mānsehra, KPK, Pakistan
View Trial Details