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)

University Hospital of Bordeaux

Status: Unknown

Conditions: Stroke Rehabilitation

Treatments: Diagnostic Test: Scale Action Research Arm Test (ARAT)

Study type: Observational

Funder types: Other

Identifiers

NCT03118648

CHUBX2015/24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 192 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

192 participants in 1 patient group

stroke

Description:

* 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.

Treatment:

Diagnostic Test: Scale Action Research Arm Test (ARAT)