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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05826236
Other study ID # CLF22/05
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 15, 2023
Est. completion date September 1, 2023

Study information

Verified date April 2023
Source Istituto Clinico Humanitas
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study aims at investigating the effects of a periarticular knee pressure stimulation on quadriceps strength and neuromuscular activity in subjects with knee ostearthritis. Twenty-five patients with end-stage knee osteoarthritis and and twenty-five age-matched healthy subjects will be enrolled. All participants will be asked to performed isometric maximal voluntary knee extension tasks with three different pressure stimuli in terms of intensity (0 mmHg, 60 mmHg, 120 mmHg) around the knee using a sphygmomanometer. Peak force and root-mean-square peak of rectus femoris, vastus medialis, and vastus lateralis will be collected.


Description:

The study aimed at assessing the effects of a periarticular pressure stimulation of the knee joint on quadriceps strength and neuromuscular activity in patients with end-stage knee osteoarthritis. Twenty-five patients with end-stage knee osteoarthritis and and twenty-five age-matched healthy subjects will be enrolled. Participants will seat on a dynamometer chair (BAR, OTBioelettronica, Italy) with hips and knees at 90 degrees and 30 degrees of flexion, respectively. Participants will perform six maximal voluntary knee extension tasks with three different pressure stimuli in terms of intensity (0 mmHg, 60 mmHg, 120 mmHg) around the knee using a sphygmomanometer. Two maximum voluntary contractions interspaced by 3 minutes of rest will be performed for each pressure level, and the peak force (N) will be collected and normalized for the highest value during the three conditions. Moreover, root-mean-square peak (RMS-peak) of rectus femoris, vastus medialis, and vastus lateralis will be recorded using bipolar surface electromyography electrodes (FREEEMG, BTS, Italy). The RMS-peak of each muscle will be normalized for its highest value among the three conditions (nRMS-peak) and used as index of neuromuscular activity.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date September 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers
Gender All
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria: - End-stage knee osteoarthritis - Age between 40 and 80 years - at least 0-90° of knee range of motion along the sagittal plane Exclusion Criteria: - Cognitive impairments or psychiatric disorders - Concomitant neurological, orthopedic, cardiovascular disorders - Lower limb orthopedic surgery or traumatic events in the previous year

Study Design


Intervention

Device:
Periarticular compression
Periarticular knee compression using a sphygmomanometer.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Istituto Clinico Humanitas

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Peak Force Changes in strength during a maximal voluntary contraction using 0mmHg, 60mmHg or 120mmHg of compression intensity. Baseline (0mmHg), 3 minute after baseline (60mmHg) and 6 minutes after baseline (120mmHg)
Secondary Changes in Root Mean Square peak Changes in neuromuscular activity during a maximal voluntary contraction using 0mmHg, 60mmHg or 120mmHg of compression intensity. Baseline (0mmHg), 3 minute after baseline (60mmHg) and 6 minutes after baseline (120mmHg)
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