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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04171401
• Other study ID #: S57757
• Status: Completed
• Start date: May 11, 2015
• Est. completion date: January 27, 2016

Study information

• Verified date: November 2019
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: January 27, 2016
• Est. primary completion date: January 27, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Balance; Distorted
• Stroke

Intervention

Other:
• In-patient stroke rehabilitation.
An in-patient multi-disciplinary stroke rehabilitation program was performed.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
KU Leuven	Universitaire Ziekenhuizen Leuven

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Limits of Stability Testing	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.	Baseline
Primary	Berg Balance Scale	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.	Baseline
Primary	Trunk Impairment Scale	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.	Baseline
Primary	Trunk Control Test	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.	Baseline