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Completed

NCT Number: NCT04171401

Limits of Stability in Sitting in Healthy Controls and Participants Post Stroke

In this cross-sectional study we will compare the limits of stability in non-ambulatory participants post stroke compared to healthy controls. This will be done by placing participants in a seated position on a force platform, that will measure centre of pressure displacements during a leaning task in multiple directions. The results of the limits of stability test will be compared to standard clinical Measures of trunk control and functional balance, to see if there is a relationship between both ways of measuring. And how balance and trunk control are affected in the subacute stroke population.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants post Stroke:

  • a stroke with clear hemiplegia (a previous stroke is accepted when complete recovery was achieved)
  • being a patient at the UZ Pellenberg
  • Functional Ambulation Catergory of two or less
  • to be able to sit independently for 2 minutes
  • to be cooperative enough to fulfill multiple Evaluations and tests
  • to be able to understand simple instructions and be able to execute those.

Exclusion criteria

Participants post Stroke:

  • to have musculoskeletal and/or other neurological disorders that could influence the protocol
  • severe communication, memory or language disorders that could disturb the understanding of the research protocol.
  • no signed informed consent

Inclusion criteria

healthy controls:

  • Age above 50
  • to be able to stand independently for 2 minutes

Exclusion criteria

healthy controls:

  • a disorder that could influence balance capabilities
  • Berg Balance Scale less than 50 Points
  • no signed informed consent

Treatment and study plan

In-patient stroke rehabilitation.

Other

An in-patient multi-disciplinary stroke rehabilitation program was performed.

Primary outcomes

  1. Limits of Stability Testing

    Time frame: Baseline

    The centre of pressure(COP) movement is measured while the patient is seated on a force platform and is asked by the software that is projected on a screen, to lean with the trunk in a certain direction and hold this position before going back to the starting position. The COP distance between start and end position is calculated, as well as the COP length of the trajectory that it takes the participant to reach his or her maximum leaning position.

  2. Berg Balance Scale

    Time frame: Baseline

    The Berg Balance Scale (BBS) is used to assess functional balance. The scale consists of 14 items, for each item the minimum score is 0 points, the maximum score is 4 points. A total amount of 56 points can be achieved on the Berg Balance Scale which indicates a normal balance for adults. A score lower than 45 points in elderly indicates that individuals may be at greater risk of falling.

  3. Trunk Impairment Scale

    Time frame: Baseline

    The Trunk Impairment Scale (TIS) assesses static and dynamic sitting balance and coordination of trunk movement. The test consists of 17 items with a minimum score of 0 and a maximum score of 23 points, which is calculated by adding up the scores from the subscales (0-7 Points for static sitting Balance, 0-10 Points for dynamic sitting Balance, 0-6 Points for coordination), with a higher scores for better trunk control.

  4. Trunk Control Test

    Time frame: Baseline

    The Trunk Control Tests consists of four items with a maximum score of 100 points. The patient is asked to turn in bed, come from lying to sitting at the bedside and stay seated at the bedside. A higher score shows better functioning.

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

  • Universitaire Ziekenhuizen KU Leuven

Registry information

Official study title

Maximum Weight-shifts in Sitting in Non-ambulatory People With Stroke Are Related With Trunk Control and Balance in Sitting and Standing

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 20, 2019
Registry last updated
Nov 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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