Trunk Control Tests in Post-stroke Context: Validity and Reliability Study

March 29, 2021 updated by: Anne-Violette Bruynnel

Trunk Joint Positional Sense and Unstable Sitting Balance Tests in Patients With Hemiparesis Post-stroke: Validity and Reliability Study

Context:

After stroke, most patients suffer from hemiparesis with variable functional consequences that can strongly impact autonomy in daily activities. Motor recovery is, therefore, an essential part of the therapeutic strategy in order to optimize the patient's capacities and functional autonomy.

Some authors suggest that trunk control would be essential in the capacities of standing balance, transfer tasks and gait. However, no studies have tested the reliability and validity of proprioceptive and sitting balance clinical tests for patients with post-stroke hemiparesis. These tests would be very useful in advancing our understanding of trunk impairments and for clinicians to manage an appropriate treatment strategy.

Objective:

The main objective is to assess the reliability of the Trunk Positional Sense Test, the unstable sitting test with forceplate and the Modified Functional Reach Test (MFRT) in individuals with post-stroke hemiparesis. The secondary objectives is 1) to assess the validity of the Trunk Positional Sense Test and the unstable sitting test with forceplate, 2) to assess the validity of a phone inertial captors to assess the instable sitting.

Method. - Thirty-two individuals with subacute post-stroke hemiparesis will be included in this study. After clinical tests (trunk strength, Balance Assessment in Standing and Sitting, Timed Up and Go test), the MFRT, Trunk Positional Sense Test and unstable sitting will be evaluated by two physiotherapists in a first session (inter-rater reliability). After a rest of 2-4 h, a second similar session was conducted with the first physiotherapist (intra-rater reliability). For unstable seated balance, two tools will be used: the force platform and a smartphone.

Reliability will be tested by calculating the intraclass correlation (ICC) and Bland-Altman analysis. For trunk positional sense test and unstable sitting test, the validity will be tested with correlations with each clinical test. The validity, between forceplate variables and inertial phone variables, will be tested with correlations.

Perspectives. - The promotion of quality tests to assess patients in clinical practice is essential. The results of this study should provide knowledge for selecting the best trunk control tests to assess the individuals after stroke and to understand the influence of trunk control on functional activities.

Study Overview

Study Type

Observational

Enrollment (Actual)

32

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

      • Geneva, Switzerland, 1206
        • Hôpitaux Universitaires de Genève (Hôpital Beau-Séjour)

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

50 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

We include a group of 32 individuals with post-stroke hemiparesis. These subjects will consist of males and females with a minimum age of 50 and a maximum of 80 years. The subjects should be able to understand the instructions and be able to sit for 30 seconds without assistance to perform the tests.

Description

Inclusion Criteria:

  • Post stroke
  • Subacute phase
  • Able to stay stable in sitting position during 30 seconds
  • Medical stability
  • Able to understand the consign (Mini-Mental State Examination >22)

Exclusion Criteria:

  • Medical complications
  • Hearing disorders
  • Previous pathologies associated with spinal disorders
  • Back pain

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Stroke
Individuals with post-stroke hemiparesis in subacute phase will be included in the study.
MicroFET 2 Handheld Dynamometer is a force evaluation testing device to evaluate the strength of various trunk muscle groups in flexion, extension, and lateral (N).
The BASS is a test to assess static and dynamic sitting and standing balance, which has been validated for post-stroke hemiparetic patients. Each test is evaluated by a score from "0" (patient needs external support) to "4" (stable without external help) for static condition and from "0" (no possibility to pick up objects) to "3" (objects picked up without external help) for dynamic condition. The maximal score (sitting, standing, static and dynamic) is 14 points.
The participant sits on a chair, gets up, walks 3m, makes a half turn in 1m2, walks 3m and comes back to sit on the chair. The time (s) to complete the task is measured.
The MFRT is a dynamic seated balance test that measures the trunk's ability to move forward, to the paretic and non paretic side (cm).
The joint positional sense test of the trunk consists in evaluating the positional error of the trunk in the sagittal plane (mm) and in the frontal plane (mm) during a trunk flexion posture (target position).
This test evaluates the balance capacities of the subject in an unstable sitting position on a seesaw (mediolateral or anteroposterior instability) with forceplate and phone application using center of pressure variables: total displacement (mm), area (mm2), deltas (mm), mean velocity (mm/s) et maximal velocity (mm/s).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reliability of trunk tests
Time Frame: The measures will be collected over a timeframe of 22 months
The inter-rater reliability will be evaluated by comparing the test results of two physiotherapists administering the same tests (Trunk position sense, Modified Functional Reach Test, unstable sitting on a seesaw), and the intra-rater reliability will be evaluated by comparing the test results of two sessions (test-retest) which will be executed by the same tester, with the intra-class correlations coefficient (ICC) and Bland-Altman analysis.
The measures will be collected over a timeframe of 22 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Construct validity
Time Frame: The measures will be collected over a timeframe of 22 months
The validity of the three tests (Trunk position sense, Modified Functional Reach Test, unstable sitting on a seesaw) with clinical tests (Balance Assessment in standing and sitting, Trunk strength, Timed Up and Go Test) will be assessed with correlations (r).
The measures will be collected over a timeframe of 22 months
Concurrent validity
Time Frame: The measures will be collected over a timeframe of 22 months
The validity between center of pressure variables (forceplate) and inertial captors' variables (phone) during the same unstable sitting balance tests on a seesaw will be assessed with correlations (r) and Bland Altman analysis.
The measures will be collected over a timeframe of 22 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Anne-Violette Bruyneel, PhD, School of Health Sciences Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 1, 2019

Primary Completion (ACTUAL)

March 29, 2021

Study Completion (ACTUAL)

March 29, 2021

Study Registration Dates

First Submitted

November 16, 2020

First Submitted That Met QC Criteria

November 16, 2020

First Posted (ACTUAL)

November 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 30, 2021

Last Update Submitted That Met QC Criteria

March 29, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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