Clinical trial NCT03118648: 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)
Official title: Relations Between the Level Upper Limb Paresis Recovery in Output of the Hospital Unit Continued Care and Rehabilitation and Its Level of Use in Lifestyle at Three and Six Months
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke Rehabilitation
Keywords: upper limb
functional recovery
activities of daily living
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients eligible to participate in the study will be adults who have experienced a first stroke and are about to leave the rehabilitation facility for their home. These people should have a good oral comprehension. They must not have a psychiatric history with hospitalization of more than 6 months. They must have been independent in the activities of daily life before their stroke. They must be affiliated to a social security scheme, be willing to participate in the study and not participate in another research.

Brief summary: The aim is to reduct spontaneous use an activities of daily living of the paretic upper limb after stroke i six months after patient discharge from rehabilitation center. The level of functional recovery at rehabilitation discharge could better guide rehabilitation strategies to enhance independence and participation in daily life.

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.

Detailed description: Adults after stroke will be recruited at post-acute rehabilitation discharge. Three evaluation times will be undertaken: at discharge, three and six months after discharge. Evaluation battery will focus on the three level of the Functioning International Classification: affected upper limb level of strength, proprioception and level of functional recovery, hemineglect, depression, cognition status, and activity level by doing a standardised instrumental task of daily living, and level of participation questionnaire. General characteristics will be taken into account: Age, social status, laterality.

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.

Eligibility criteria: Inclusion Criteria:

* 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 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:

* Lack of minimum functional motor recovery in paretic upper limb allowing the patient to go put hand to his mouth and to realize do a 45 degrees abduction with the paretic upper limb.
* 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).

Primary outcomes:
measure: Motor Activity
timeFrame: Month 6
Secondary outcomes:
measure: Action Arm
timeFrame: Day 0
measure: Action Arm
timeFrame: Day 180
measure: Cognitive abilities
timeFrame: Day 0
measure: Cognitive abilities
timeFrame: Day 180
measure: "Mesure des HAbitudes de VIE" (MHAVIE)
timeFrame: Day 0
measure: "Mesure des HAbitudes de VIE" (MHAVIE)
timeFrame: Day 180
measure: "Montreal Cognitive Assessment" (MoCA)
timeFrame: Day 0
measure: "Montreal Cognitive Assessment" (MoCA)
timeFrame: Day 180
measure: Aphasic Depression Rating (ADRS)
timeFrame: Day 0
measure: Aphasic Depression Rating (ADRS)
timeFrame: Day 180
measure: Unilateral spatial neglect (NSU) in the vicinity of extrapersonal space
timeFrame: Day 0
measure: Unilateral spatial neglect (NSU) in the vicinity of extrapersonal space
timeFrame: Day 180
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Bordeaux University Hospital
Study officials:
affiliation: University Hospital, Bordeaux
name: Eric SORITA, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique du CHU de Bordeaux
name: Paul PEREZ, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.