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Completed

NCT Number: NCT04639453

Trunk Control Tests in Post-stroke Context: 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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpitaux Universitaires de Genève (Hôpital Beau-Séjour)

Geneva, 1206, Switzerland

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Trunk strength with hand-held dynamometer

Diagnostic Test

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).

Balance Assessment in Sitting and Standing test (BASS)

Diagnostic Test

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.

Timed Up and Go test

Diagnostic Test

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.

Modified Functional Reach Test (MFRT)

Diagnostic Test

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).

Joint Position sense test (trunk)

Diagnostic Test

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).

Unstable sitting in a seesaw

Diagnostic Test

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

Anne-Violette Bruynnel

Other

Collaborators

  • University Hospital, Geneva

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 20, 2020
Registry last updated
Mar 30, 2021

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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