Recovery of Upper Limb Paresis at Discharge After Stroke and Its Level of Use in Activities of Daily Living 3 to 6 Months Later (Post AVC-AVQ)
NCT ID: NCT03118648
Last Updated: 2017-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
192 participants
OBSERVATIONAL
2017-07-01
2020-06-01
Brief Summary
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This study aims to determine, in patients after stroke, the optimal affected upper limb recovery threshold at rehabilitation discharge to predict spontaneous level of use of affected upper limb in activities of daily living, six month later.
This study is a multicentric prognostic prospective cohort study. The main prognostic variable will be the Action Arm Test (ARAT, Lyle, 1981) score at rehabilitation discharge and the predicted variable will be the Motor Activity Log - 28 (Taub et al. 1993) score at 6 months post discharge.
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Detailed Description
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At six months, the spontaneous level of affected upper arm use in daily living will also be assessed using accelerometers.
As the main aim of the study is to build a prediction model, the study size is calculated to observe a minimal number of events by potentially predictive variable. We consider here 7.5 events by independent variable (Vittinghof and McCulloch, 2007) and eight independent variables. According to literature review, we estimated that 35% of adults included in this study would spontaneously use their affected upper arm in activities of daily living six months after discharge. According to these data and considering 10% of protocol deviations, we calculated that 192 subjects will have to be included in the study. The inclusion duration will be 30 months.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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stroke
* Patients over 18 years old leaving the correctional institution with orientation back home
* First stroke deficit with non-regressive clinical expression in 24 hours
* Independent in activities of daily living and living at home before stroke. This earlier independence is confirmed by the absence of professional carers in personal care activities
* Proper oral understanding as measured by score 7 in the Language Screening Test (LAST) (Flamand-Roze et al, 2011)
* No psychiatric history that led to hospitalization for more than six months
* Written informed consent after reading the briefing note
* Patient affiliated or beneficiary of a social security scheme.
Scale Action Research Arm Test (ARAT)
Measuring the functional recovery of the paretic upper limb rehabilitation outing with the scale ARAT
Interventions
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Scale Action Research Arm Test (ARAT)
Measuring the functional recovery of the paretic upper limb rehabilitation outing with the scale ARAT
Eligibility Criteria
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Inclusion Criteria
* First stroke deficit with non-regressive clinical expression in 24 hours
* Independent in activities of daily living and living at home and daily activities independence before the stroke. This earlier independence is confirmed by the absence of professional carers in personal care activities (yes / no)
* Proper oral understanding as measured by score 7 in the language screening test LAST (Flamand-Roze et al, 2011)
* No psychiatric history that led to hospitalization for more than six months
* Patient has given its consent within the period provided after reading the briefing note
* Patient affiliated or beneficiary of a social security scheme.
Exclusion Criteria
* Barthel Index score (BI) less than or equal to 40. It is suggested in the literature that a score less than or equal to 40 is a key score of total dependence
* Persistent severe hemineglect (bells test score \> 6).
18 Years
ALL
No
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Eric SORITA, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Paul PEREZ, MD
Role: STUDY_CHAIR
Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique du CHU de Bordeaux
Locations
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Bordeaux University Hospital
Bordeaux, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Lyle RC. A performance test for assessment of upper limb function in physical rehabilitation treatment and research. Int J Rehabil Res. 1981;4(4):483-92. doi: 10.1097/00004356-198112000-00001. No abstract available.
Taub E, Miller NE, Novack TA, Cook EW 3rd, Fleming WC, Nepomuceno CS, Connell JS, Crago JE. Technique to improve chronic motor deficit after stroke. Arch Phys Med Rehabil. 1993 Apr;74(4):347-54.
Vittinghoff E, McCulloch CE. Relaxing the rule of ten events per variable in logistic and Cox regression. Am J Epidemiol. 2007 Mar 15;165(6):710-8. doi: 10.1093/aje/kwk052. Epub 2006 Dec 20.
Uswatte G, Giuliani C, Winstein C, Zeringue A, Hobbs L, Wolf SL. Validity of accelerometry for monitoring real-world arm activity in patients with subacute stroke: evidence from the extremity constraint-induced therapy evaluation trial. Arch Phys Med Rehabil. 2006 Oct;87(10):1340-5. doi: 10.1016/j.apmr.2006.06.006.
Veerbeek JM, Kwakkel G, van Wegen EE, Ket JC, Heymans MW. Early prediction of outcome of activities of daily living after stroke: a systematic review. Stroke. 2011 May;42(5):1482-8. doi: 10.1161/STROKEAHA.110.604090. Epub 2011 Apr 7.
Rand D, Eng JJ. Predicting daily use of the affected upper extremity 1 year after stroke. J Stroke Cerebrovasc Dis. 2015 Feb;24(2):274-83. doi: 10.1016/j.jstrokecerebrovasdis.2014.07.039. Epub 2014 Dec 18.
Other Identifiers
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CHUBX2015/24
Identifier Type: -
Identifier Source: org_study_id
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