Clinical trial NCT04639453: Trunk Control Tests in Post-stroke Context: Validity and Reliability Study
Official title: Trunk Joint Positional Sense and Unstable Sitting Balance Tests in Patients With Hemiparesis Post-stroke: Validity and Reliability Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Stroke
Trunk
Postural control
Reliability
Validity
Lead sponsor: School of Health Sciences Geneva
Sponsor class: OTHER
Collaborators: name: University Hospital, Geneva
First posted: 2020-11-20
Enrollment: 32
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Reliability of trunk tests
timeFrame: The measures will be collected over a timeframe of 22 months
Secondary outcomes:
measure: Construct validity
timeFrame: The measures will be collected over a timeframe of 22 months
measure: Concurrent validity
timeFrame: The measures will be collected over a timeframe of 22 months
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève (Hôpital Beau-Séjour)
Study officials:
affiliation: School of Health Sciences Geneva
name: Anne-Violette Bruyneel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Han J, Waddington G, Adams R, Anson J, Liu Y. Assessing proprioception: A critical review of methods. J Sport Health Sci. 2016 Mar;5(1):80-90. doi: 10.1016/j.jshs.2014.10.004. Epub 2015 Feb 3.
citation: Jung K, Kim Y, Chung Y, Hwang S. Weight-shift training improves trunk control, proprioception, and balance in patients with chronic hemiparetic stroke. Tohoku J Exp Med. 2014 Mar;232(3):195-9. doi: 10.1620/tjem.232.195.
citation: Katz-Leurer M, Fisher I, Neeb M, Schwartz I, Carmeli E. Reliability and validity of the modified functional reach test at the sub-acute stage post-stroke. Disabil Rehabil. 2009;31(3):243-8. doi: 10.1080/09638280801927830.
citation: Learman KE, Benedict JA, Ellis AR, Neal AR, Wright JA, Landgraff NC. An exploration of trunk reposition error in subjects with acute stroke: An observational design. Top Stroke Rehabil. 2016 Jun;23(3):200-7. doi: 10.1080/10749357.2016.1138671. Epub 2016 Feb 5.
citation: Morishita M, Amimoto K, Matsuda T, Arai Y, Yamada R, Baba T. Analysis of dynamic sitting balance on the independence of gait in hemiparetic patients. Gait Posture. 2009 Jun;29(4):530-4. doi: 10.1016/j.gaitpost.2008.12.005. Epub 2009 Jan 9.
citation: Oh DS, Choi JD. The effect of motor imagery training for trunk movements on trunk muscle control and proprioception in stroke patients. J Phys Ther Sci. 2017 Jul;29(7):1224-1228. doi: 10.1589/jpts.29.1224. Epub 2017 Jul 15.
citation: Ryerson S, Byl NN, Brown DA, Wong RA, Hidler JM. Altered trunk position sense and its relation to balance functions in people post-stroke. J Neurol Phys Ther. 2008 Mar;32(1):14-20. doi: 10.1097/NPT.0b013e3181660f0c.