Effect of Short-term Motor Training on Accuracy and Precision of Knee Movement in Human With and Without Knee Pain

January 12, 2021 updated by: Kelun Wang, Aalborg University
The objects of this research are to investigate the ability of the motor learning and test the possible differences between younger and older healthy human, and between non-pain and acute experimental pain and chronic clinical pain conditions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The project consists of four experimental studies. In the first experiment, younger and older healthy human subjects are involved in a short-term neuromuscular training on the accuracy and precision of knee movement to investigate the possible age effect of the motor learning. The second experiment focuses on the experimental pain on the learning effect of the younger subjects. The third experiment will investigate a group of knee osteoarthritis patients to show the influence of chronic pain on the motor training compared with age-, gender-matched pain free subjects. 3D camera tracking system will be used to record the knee movements at the baseline and after 6-day motor task training. The variability in amplitude of the values of knee movements was transformed to percentage in relation to the target position (accuracy) or to the mean position (precision). The results of the study will contribute to both basic and clinical understanding of the mechanisms related to knee movement control and influences of varies painful conditions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9220
        • Aalborg University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • Aged 18-30 or 50-65 years

    • Free from ongoing or chronic pain
    • Right dominant leg
    • Speak and understand English
    • Aged 50-65 years.
    • Diagnosed with knee OA (according to American College of Rheumatology classification) with pain in left or both knees for more than six months
    • Have ongoing pain rated above 2 on a 0-10 Visual Analogues Scale (VAS) in the previous week.
    • Right dominant leg
    • Speak and understand English
    • Aged 50-65 years
    • Diagnosed with knee OA
    • Have had total knee arthroplasty on left or both knees
    • Right dominant leg
    • Speak and understand English

Exclusion Criteria:

  • • Pregnancy or intent to become pregnant, breast feeding

    • Regular use of analgesics, including simple analgesia and NSAIDs
    • Frequent recreational drug or alcohol use
    • History of knee joint pathology or injury
    • Previous neurologic, musculoskeletal or mental illnesses
    • Practicing sport activities on a regular basis
    • Lack of ability to cooperate
    • Regular use of analgesics, including analgesia and NSAIDs for the last 24 hours
    • Frequent recreational drug or alcohol use
    • Previous neurologic, musculoskeletal or mental illnesses
    • Practicing sports activities on a regular basis
    • Lack of ability to cooperate
    • Regular use of analgesics, including analgesia and NSAIDs for the last 24 hours
    • Frequent recreational drug or alcohol use
    • Other disorders or injuries in the knee joints
    • Previous neurologic, musculoskeletal or mental illnesses
    • Practicing sports activities on a regular basis
    • Lack of ability to cooperate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Hypertonic saline
A bolus injection (0.25 ml) of hypertonic saline (5%) is injected into the left infrapatellar fat pad.
Drug: Hypertonic saline
A bolus injection (0.25 ml) of hypertonic saline (5%) into the left infrapatellar fat pad.
Other: Motor training
All the subjects recruited need to have a short-term motor task training at home. 30 times a session, totally 2 sessions a day for 6 days
Placebo Comparator: Isotonic saline
A bolus injection (0.25 ml) of isotonic saline (0.9 %) is injected into the left infrapatellar fat pad.
Other: Motor training
All the subjects recruited need to have a short-term motor task training at home. 30 times a session, totally 2 sessions a day for 6 days
Drug: isotonic saline
A bolus injection (0.25 ml) of isotonic saline (5%) into the left infrapatellar fat pad.
Experimental: Motor training
All the subjects recruited need to have a short-term motor task training at home. 30 times a session, totally 2 sessions a day for 6 days
Other: Motor training
All the subjects recruited need to have a short-term motor task training at home. 30 times a session, totally 2 sessions a day for 6 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
knee movement assessment
Time Frame: Change from baseline, up to 7 days after the first session
There are two sessions in total, seperated by a 6 days motor training. Using 3D camera to calculate the accuracy and precision of knee movements at 30, 45, 60 degree respectively both with and without visual feedback (baseline), before and after motor training, also before and after injection.
Change from baseline, up to 7 days after the first session

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of pain
Time Frame: Only on day 7 (second session), up to 24 hours
Immediately following the injection, participants will be instructed to rate the pain intensity for ten minutes using a digital visual analogue scale (VAS; eVas Software: Aalborg University, Denmark), on a tablet.The scale will be measured from 0 to10, where 0 represents 'no pain' and 10 represents 'worst pain imaginable'.
Only on day 7 (second session), up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aalborg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 28, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 25, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 31, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • N-20170080

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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