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)
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|ClinicalTrials.gov Identifier: NCT03118648|
Recruitment Status : Unknown
Verified June 2017 by University Hospital, Bordeaux.
Recruitment status was: Not yet recruiting
First Posted : April 18, 2017
Last Update Posted : June 22, 2017
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.
|Condition or disease||Intervention/treatment|
|Stroke Rehabilitation||Diagnostic Test: Scale Action Research Arm Test (ARAT)|
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|
|Estimated Enrollment :||192 participants|
|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|
|Estimated Study Start Date :||July 1, 2017|
|Estimated Primary Completion Date :||June 1, 2020|
|Estimated Study Completion Date :||June 1, 2020|
Diagnostic Test: Scale Action Research Arm Test (ARAT)
Measuring the functional recovery of the paretic upper limb rehabilitation outing with the scale ARAT
- Motor Activity [ Time Frame: Month 6 ]Score of Motor Activity Log scale
- Action Arm [ Time Frame: Day 0 ]Score of Action Research Arm Test scale
- Action Arm [ Time Frame: Day 180 ]Score of Action Research Arm Test scale
- Cognitive abilities [ Time Frame: Day 0 ]Score with kettle test
- Cognitive abilities [ Time Frame: Day 180 ]Score with kettle test
- "Mesure des HAbitudes de VIE" (MHAVIE) [ Time Frame: Day 0 ]Score of "Mesure des HAbitudes de VIE" scale (MHAVIE)
- "Mesure des HAbitudes de VIE" (MHAVIE) [ Time Frame: Day 180 ]Score of "Mesure des HAbitudes de VIE" scale (MHAVIE)
- "Montreal Cognitive Assessment" (MoCA) [ Time Frame: Day 0 ]Score of "Montreal Cognitive Assessment" (MoCA)
- "Montreal Cognitive Assessment" (MoCA) [ Time Frame: Day 180 ]Score of "Montreal Cognitive Assessment" (MoCA)
- Aphasic Depression Rating (ADRS) [ Time Frame: Day 0 ]Score of Aphasic Depression Rating Scale (ADRS)
- Aphasic Depression Rating (ADRS) [ Time Frame: Day 180 ]Score of Aphasic Depression Rating Scale (ADRS)
- Unilateral spatial neglect (NSU) in the vicinity of extrapersonal space [ Time Frame: Day 0 ]Score of "Bell test (test de barrage des cloches)"
- Unilateral spatial neglect (NSU) in the vicinity of extrapersonal space [ Time Frame: Day 180 ]Score of "Bell test (test de barrage des cloches)"
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118648
|Contact: Eric SORITA, PhDfirstname.lastname@example.org|
|Bordeaux University Hospital|
|Contact: Eric SORITA, PhD +33557820967 email@example.com|
|Principal Investigator: Eric SORITA, PhD|
|Sub-Investigator: Patrick DEHAIL, MD, PhD|
|Principal Investigator:||Eric SORITA, PhD||University Hospital, Bordeaux|
|Study Chair:||Paul PEREZ, MD||Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique du CHU de Bordeaux|