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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)

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03118648
Acronym
Post AVC-AVQ
Enrollment
192
Registered
2017-04-18
Start date
2017-07-01
Completion date
2020-06-01
Last updated
2017-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke Rehabilitation

Keywords

upper limb, functional recovery, activities of daily living

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.

Interventions

DIAGNOSTIC_TESTScale Action Research Arm Test (ARAT)

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

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Motor ActivityMonth 6Score of Motor Activity Log scale

Secondary

MeasureTime frameDescription
Cognitive abilitiesDay 0Score with kettle test
Mesure des HAbitudes de VIE (MHAVIE)Day 0Score of Mesure des HAbitudes de VIE scale (MHAVIE)
Action ArmDay 0Score of Action Research Arm Test scale
Aphasic Depression Rating (ADRS)Day 0Score of Aphasic Depression Rating Scale (ADRS)
Unilateral spatial neglect (NSU) in the vicinity of extrapersonal spaceDay 0Score of Bell test (test de barrage des cloches)
Montreal Cognitive Assessment (MoCA)Day 0Score of Montreal Cognitive Assessment (MoCA)

Countries

France

Contacts

Primary ContactEric SORITA, PhD
eric.sorita@chu-bordeaux.fr+33557820967

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026