Motor Performance Modulation After Total Knee Replacement

Total Knee Replacement Clinical Trial

Official title:

Motor Performance Modulation After Total Knee Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03997565
• Other study ID #: 749
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: September 1, 2019

Study information

• Verified date: September 2021
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age between 40 and 80 years
• TKR because of primary gonarthrosis
• Flexion = 90° and complete knee extension
• Able to perform a Sit to Stand from a 46 cm high chair, without upper limb use
• Able to walk at least 50 meters without walking aids

Exclusion Criteria:

• TKR because of traumatic event
• Patients undergone to tibial or femoral osteotomy
• Partial or Total TKR revision
• Cognitive and psychiatric impairments
• Presence of neurological, internist or musculoskeletal system pathologies that may affect functional or motor recovery Healthy subjects will have to comply with all the eligibility criteria just mentioned except for the inclusion criterion: Intervention of TKR following primary gonarthrosis

Related Conditions & MeSH terms

• Total Knee Replacement

Intervention

Procedure:
• TKR
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.

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Peak Torque (PT) in N*m	Force reproduction error between the PT-target and the PT-observed during knee extension with an isokinetic dynamometer (O = 60 °/s)	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)
Secondary	Change in Overshoot (OS) in N	The error between OS-target and OS-observed during Sit-to-Stand using two force platforms.	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)
Secondary	Change in Walking speed (WS) in m/s	Error between "target speed" and "observed speed" during 10 meters walking test	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)
Secondary	Change in pain using Visual Analogue Scale (VAS)	Pain will be assessed with Visual Analogue Scale (VAS 0-10) ranging from 0 (absence of pain) to 10 (maximum pain)	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)
Secondary	Change in exertion using Modified Borg Scale	Perceived exertion will be assessed with Modified Borg Scale (0-10), ranging from 0 (no exertion) to 10 (maximum exertion)	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)
Secondary	Change in perceived body weight distribution using Visual Analogue Scale (VAS)	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.	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)