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

Completed

• Conditions: Stroke
• Interventions: Diagnostic Test: Trunk strength with hand-held dynamometer; Diagnostic Test: Balance Assessment in Sitting and Standing test (BASS); Diagnostic Test: Timed Up and Go test; Diagnostic Test: Modified Functional Reach Test (MFRT); Diagnostic Test: Joint Position sense test (trunk); Diagnostic Test: Unstable sitting in a seesaw

• Registration Number: NCT04639453
• Lead Sponsor: Anne-Violette Bruynnel

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2020-11-16
• Study First Submitted QC: 2020-11-16
• Study First Posted: 2020-11-20
• Status Verified: 2021-03
• Primary Completion: 2021-03-29
• Study Completion: 2021-03-29
• Last Update Submitted: 2021-03-29
• Last Update Posted: 2021-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stroke	Joint Position sense test (trunk)	Individuals with post-stroke hemiparesis in subacute phase will be included in the study.
Stroke	Trunk strength with hand-held dynamometer	Individuals with post-stroke hemiparesis in subacute phase will be included in the study.
Stroke	Balance Assessment in Sitting and Standing test (BASS)	Individuals with post-stroke hemiparesis in subacute phase will be included in the study.
Stroke	Unstable sitting in a seesaw	Individuals with post-stroke hemiparesis in subacute phase will be included in the study.
Stroke	Modified Functional Reach Test (MFRT)	Individuals with post-stroke hemiparesis in subacute phase will be included in the study.
Stroke	Timed Up and Go test	Individuals with post-stroke hemiparesis in subacute phase will be included in the study.

Primary Outcome Measures

Name	Time	Method
Reliability of trunk tests	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 Outcome Measures

Name	Time	Method
Construct validity	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).
Concurrent validity	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.

Trial Locations

Locations (1)

Hôpitaux Universitaires de Genève (Hôpital Beau-Séjour); 🇨🇭 Geneva, Switzerland