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GaitNCT03135587

The Relationship Between Increasing Loading and Kinematic Parameters

A study testing Loading level in people with Gait, run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to investigate the influence of increasing loading to kinematic parameters of normal people while walking on the treadmill. Read more about this study

Who is it for?
Ages 20 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Gait
What is being tested?
Loading level
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
26 Apr 2017to 17 May 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 20< age < 30.
  • Body mass index < 30.
  • No history of major injury or surgery in lower limbs.
  • No symptoms of lower limbs.
  • Physical examination to test the lower limbs to be normal.
  • The habit of moderate exercise (e.g. Jogging) at least once a week for at least 30 minutes.

Who cannot join

  • Body mass index >30.
  • Injury or surgery in hip/knee/ankle.
  • History trauma in the lower limbs (e.g. fracture).
  • Neuropathic disease.
  • Muscular disease.
  • Lack ability to finish the procedure physically or mentally.
  • Easy to fall.
  • Any other conditions that can influence gait parameters of the lower limbs.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command

    Guangzhou, Guangdong, 510010

Other trials in China

About this study

Official title: Are There Correlations Between Increasing Loading and Kinematic Parameters of Normal People?

The aim of this study is to investigate the influence of increasing loading to kinematic parameters of normal people while walking on the treadmill.

Conditions
Gait
Being tested
Loading level
Keywords
Knee, Loading, Kinematics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Loading levelProcedure or surgery

    Once participants are eligible, they will undergo the experimental procedure. Before data collection, they will walk on a treadmill in barefoot for ten minutes to adapt the condition. The gait analysis system will collect the data while they walk on the treadmill in barefoot with selected weight loading suit at 3.0km/h.

Study groups in NCT03135587
Study groupRoleWhat they receive
Weight 0ExperimentalThe participants will not carry any loading to walk on treadmill.
Receives: Procedure: Loading level
Weight 10ExperimentalThe participants will wear 10kg loading suit to walk on treadmill.
Receives: Procedure: Loading level
Weight 20ExperimentalThe participants will wear 20kg loading suit to walk on treadmill.
Receives: Procedure: Loading level
Weight 30ExperimentalThe participants will wear 30kg loading suit to walk on treadmill.
Receives: Procedure: Loading level
Weight 40ExperimentalThe participants will wear 40kg loading suit to walk on treadmill.
Receives: Procedure: Loading level
Weight 50ExperimentalThe participants will wear 50kg loading suit to walk on treadmill.
Receives: Procedure: Loading level

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Knee flexion/extension angle at initial contact during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  2. Knee internal/external rotation angle at initial contact during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  3. Knee adduction/abduction angle at initial contact during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  4. Knee anterior/posterior translation at initial contact during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  5. Knee medial/lateral translation at initial contact during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  6. Knee proximal/distal translation at initial contact during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  7. Knee flexion/extension angle at opposite toe off during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  8. Knee adduction/abduction angle at opposite toe off during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  9. Knee internal/external rotation angle at opposite toe off during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  10. Knee anterior/posterior translation at opposite toe off during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  11. Knee distal/proximal translation at opposite toe off during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  12. Knee medial/lateral translation at opposite toe off during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  13. Knee flexion/extension angle at heel rise during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  14. Knee internal/external rotation angle at heel rise during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  15. Knee adduction/abduction angle at heel rise during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  16. Knee anterior/posterior translation at heel rise during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  17. Knee distal/proximal translation at heel rise during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  18. Knee medial/lateral translation at heel rise during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  19. Knee flexion/extension angle at opposite initial contact during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  20. Knee adduction/abduction angle at opposite initial contact during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  21. Knee internal/external rotation angle at opposite initial contact during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  22. Knee anterior/posterior translation at opposite initial contact during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  23. Knee distal/proximal translation at opposite initial contact during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  24. Knee medial/lateral translation at opposite initial contact during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  25. Knee flexion/extension angle at toe off during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  26. Knee adduction/abduction angle at toe off during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  27. Knee internal/external rotation angle at toe off during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  28. Knee anterior/posterior translation at toe off during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  29. Knee distal/proximal translation at toe off during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  30. Knee medial/lateral translation at toe off during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  31. Knee flexion/extension angle at feet adjacent during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  32. Knee internal/external rotation angle at feet adjacent during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  33. Knee adduction/abduction angle at feet adjacent during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  34. Knee anterior/posterior translation at feet adjacent during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  35. Knee distal/proximal translation at feet adjacent during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  36. Knee medial/lateral translation at feet adjacent during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  37. Knee flexion/extension angle at tibial vertical during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  38. Knee adduction/abduction angle at tibial vertical during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  39. Knee internal/external rotation angle at tibial vertical during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  40. Knee anterior/posterior translation at tibial vertical during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  41. Knee distal/proximal translation at tibial vertical during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  42. Knee medial/lateral translation at tibial vertical during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  43. Range of motion of knee flexion/extension angle .

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  44. Range of motion of knee adduction/abduction angle

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  45. Range of motion of knee internal/external rotation angle.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  46. Range of motion of knee anterior/posterior translation.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  47. Range of motion of knee distal/proximal translation.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  48. Range of motion of knee medial/lateral translation.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    Measured: 1 Day

  49. Loading of participants

    The unit is kg.

    Measured: 1 Day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2017
  2. Study start26 Apr 2017
  3. Primary completion13 May 2017
  4. Study completion17 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03135587
Sponsor's protocol ID
GuangzhouGH006
Status last verified
May 2017
First submitted
26 Apr 2017
Last updated
18 May 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Loading level in people with Gait, run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knee flexion/extension angle at initial contact during gait. (time frame: 1 Day). The study lists 49 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2017.

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