- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04146311
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
Completed
Intervention / Treatment
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
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Aalborg, Denmark, 9220
- Aalborg University
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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.
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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
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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.
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Change from baseline, up to 7 days after the first session
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of pain
Time Frame: Only on day 7 (second session), up to 24 hours
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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'.
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Only on day 7 (second session), up to 24 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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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