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)

NCT03118648 | Unknown

• 1 other identifier: CHUBX2015/24
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Rehabilitation

Keywords

upper limb; functional recovery; activities of daily living

Outcome Measures

Primary Outcomes (1)

• Motor Activity

  Score of Motor Activity Log scale

  Month 6

Secondary Outcomes (12)

• Action Arm

  Day 0

• Action Arm

  Day 180

• Cognitive abilities

  Day 0

• Cognitive abilities

  Day 180

• "Mesure des HAbitudes de VIE" (MHAVIE)

  Day 0

Study Arms (1)

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)

Interventions

Scale Action Research Arm Test (ARAT) DIAGNOSTIC_TEST

Measuring the functional recovery of the paretic upper limb rehabilitation outing with the scale ARAT

stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Bordeaux University Hospital

Bordeaux, France

Location

Related Publications (6)

• 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.

  PMID: 7333761 BACKGROUND

• 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.

  PMID: 8466415 BACKGROUND

• 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.

  PMID: 17182981 BACKGROUND

• 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.

  PMID: 17023243 BACKGROUND

• 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.

  PMID: 21474812 BACKGROUND

• 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.

  PMID: 25533758 BACKGROUND

Study Officials

• Eric SORITA, PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Paul PEREZ, MD

  Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique du CHU de Bordeaux

  STUDY CHAIR

Central Study Contacts

Eric SORITA, PhD

CONTACT

+33557820967; eric.sorita@chu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 18, 2017
• Study Start: July 1, 2017
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: June 22, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)