NCT05826236

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

April 15, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

April 24, 2023

Status Verified

April 1, 2023

Enrollment Period

2 months

First QC Date

April 7, 2023

Last Update Submit

April 20, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Changes in Root Mean Square peak

    Baseline (0mmHg), 3 minute after baseline (60mmHg) and 6 minutes after baseline (120mmHg)

Study Arms (2)

Patients with knee osteoarthritis

Periarticular knee compression using a sphygmomanometer.

Device: Periarticular compression

Healthy subjects

Periarticular knee compression using a sphygmomanometer.

Device: Periarticular compression

Interventions

Periarticular knee compression using a sphygmomanometer.

Healthy subjectsPatients with knee osteoarthritis

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with end-stage knee osteoarthritis with the aforementioned eligibility criteria and age-matched healthy subjects with the same criteria except "end-stage knee osteoarthritis".

You may qualify if:

  • End-stage knee osteoarthritis
  • Age between 40 and 80 years
  • at least 0-90° of knee range of motion along the sagittal plane

You may not qualify if:

  • Cognitive impairments or psychiatric disorders
  • Concomitant neurological, orthopedic, cardiovascular disorders
  • Lower limb orthopedic surgery or traumatic events in the previous year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, KneeMuscle Weakness

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesMuscular DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2023

First Posted

April 24, 2023

Study Start

April 15, 2023

Primary Completion

June 1, 2023

Study Completion

September 1, 2023

Last Updated

April 24, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share