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

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

Interventional

Enrollment (Actual)

60

Phase

  • 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

      • 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

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
Intervention / Treatment
Active Comparator: Hypertonic saline
A bolus injection (0.25 ml) of hypertonic saline (5%) is injected into the left infrapatellar fat pad.
A bolus injection (0.25 ml) of hypertonic saline (5%) into the left infrapatellar fat pad.
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.
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
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
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

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

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.

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)

October 30, 2019

Primary Completion (Actual)

November 28, 2020

Study Completion (Actual)

December 20, 2020

Study Registration Dates

First Submitted

October 25, 2019

First Submitted That Met QC Criteria

October 29, 2019

First Posted (Actual)

October 31, 2019

Study Record Updates

Last Update Posted (Actual)

January 13, 2021

Last Update Submitted That Met QC Criteria

January 12, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID 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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