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) (Post AVC-AVQ)

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

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.

Study Overview

• Status: Unknown
• Conditions: Stroke Rehabilitation
• Intervention / Treatment: Diagnostic test: Scale Action Research Arm Test (ARAT)

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.

• Study Type: Observational
• Enrollment (Anticipated): 192

Contacts and Locations

• Study Contact: Name: Eric SORITA, PhD; Phone Number: +33557820967; Email: eric.sorita@chu-bordeaux.fr

Study Locations

• France
  • Bordeaux, France
    • Bordeaux University Hospital
    • Contact: Eric SORITA, PhD; Phone Number: +33557820967; Email: eric.sorita@chu-bordeaux.fr
    • Principal Investigator: Eric SORITA, PhD
    • Sub-Investigator: Patrick DEHAIL, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Diagnostic test: Scale Action Research Arm Test (ARAT); Measuring the functional recovery of the paretic upper limb rehabilitation outing with the scale ARAT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor Activity	Score of Motor Activity Log scale	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Action Arm	Score of Action Research Arm Test scale	Day 0
Action Arm	Score of Action Research Arm Test scale	Day 180
Cognitive abilities	Score with kettle test	Day 0
Cognitive abilities	Score with kettle test	Day 180
"Mesure des HAbitudes de VIE" (MHAVIE)	Score of "Mesure des HAbitudes de VIE" scale (MHAVIE)	Day 0
"Mesure des HAbitudes de VIE" (MHAVIE)	Score of "Mesure des HAbitudes de VIE" scale (MHAVIE)	Day 180
"Montreal Cognitive Assessment" (MoCA)	Score of "Montreal Cognitive Assessment" (MoCA)	Day 0
"Montreal Cognitive Assessment" (MoCA)	Score of "Montreal Cognitive Assessment" (MoCA)	Day 180
Aphasic Depression Rating (ADRS)	Score of Aphasic Depression Rating Scale (ADRS)	Day 0
Aphasic Depression Rating (ADRS)	Score of Aphasic Depression Rating Scale (ADRS)	Day 180
Unilateral spatial neglect (NSU) in the vicinity of extrapersonal space	Score of "Bell test (test de barrage des cloches)"	Day 0
Unilateral spatial neglect (NSU) in the vicinity of extrapersonal space	Score of "Bell test (test de barrage des cloches)"	Day 180

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Eric SORITA, PhD, University Hospital, Bordeaux; Study Chair: Paul PEREZ, MD, Unité de Soutien Méthodologique à la Recherche clinique et épidémiologique du CHU de Bordeaux

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2017
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: April 13, 2017
• First Submitted That Met QC Criteria: April 13, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): June 22, 2017
• Last Update Submitted That Met QC Criteria: June 21, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: activities of daily living; upper limb; functional recovery
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paresis
• Other Study ID Numbers: CHUBX2015/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No