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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.


Condition or disease Intervention/treatment
Stroke Rehabilitation 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.

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Study Type : Observational
Estimated Enrollment : 192 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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




Primary Outcome Measures :
  1. Motor Activity [ Time Frame: Month 6 ]
    Score of Motor Activity Log scale


Secondary Outcome Measures :
  1. Action Arm [ Time Frame: Day 0 ]
    Score of Action Research Arm Test scale

  2. Action Arm [ Time Frame: Day 180 ]
    Score of Action Research Arm Test scale

  3. Cognitive abilities [ Time Frame: Day 0 ]
    Score with kettle test

  4. Cognitive abilities [ Time Frame: Day 180 ]
    Score with kettle test

  5. "Mesure des HAbitudes de VIE" (MHAVIE) [ Time Frame: Day 0 ]
    Score of "Mesure des HAbitudes de VIE" scale (MHAVIE)

  6. "Mesure des HAbitudes de VIE" (MHAVIE) [ Time Frame: Day 180 ]
    Score of "Mesure des HAbitudes de VIE" scale (MHAVIE)

  7. "Montreal Cognitive Assessment" (MoCA) [ Time Frame: Day 0 ]
    Score of "Montreal Cognitive Assessment" (MoCA)

  8. "Montreal Cognitive Assessment" (MoCA) [ Time Frame: Day 180 ]
    Score of "Montreal Cognitive Assessment" (MoCA)

  9. Aphasic Depression Rating (ADRS) [ Time Frame: Day 0 ]
    Score of Aphasic Depression Rating Scale (ADRS)

  10. Aphasic Depression Rating (ADRS) [ Time Frame: Day 180 ]
    Score of Aphasic Depression Rating Scale (ADRS)

  11. Unilateral spatial neglect (NSU) in the vicinity of extrapersonal space [ Time Frame: Day 0 ]
    Score of "Bell test (test de barrage des cloches)"

  12. Unilateral spatial neglect (NSU) in the vicinity of extrapersonal space [ Time Frame: Day 180 ]
    Score of "Bell test (test de barrage des cloches)"



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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).

Information from the National Library of Medicine

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


Contacts
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Contact: Eric SORITA, PhD +33557820967 eric.sorita@chu-bordeaux.fr

Locations
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France
Bordeaux University Hospital
Bordeaux, France
Contact: Eric SORITA, PhD    +33557820967    eric.sorita@chu-bordeaux.fr   
Principal Investigator: Eric SORITA, PhD         
Sub-Investigator: Patrick DEHAIL, MD, PhD         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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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
Publications:
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03118648    
Other Study ID Numbers: CHUBX2015/24
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
upper limb
functional recovery
activities of daily living
Additional relevant MeSH terms:
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Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations