Clinical trial NCT03754166: Feasibility of Constraint-induced Therapy Combined With Visual-spatial Cueing Strategy in Patients With Acute Stroke
Official title: Feasibility of Modified Constraint-induced Movement Therapy Combined With Visual-spatial Cueing Strategy in Patients With Acute Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Stroke
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to test the feasibility of a constraint intervention combined with visual-spatial cueing strategy in patients with acute stroke to improve their daily life activities.

Detailed description: As part of treatment in acute stroke (from D0 to D14), the investigators were able to observe that despite motor recovery during physiotherapy sessions, it remained difficult for some patients to use their affected arm (AA) during activities of daily life (ADL). This mechanism of "learned non-use" would be due to a cognitive process decreasing the use of the AA and could partly explain that 75% of patients maintain an upper limb deficit at 3-6 month post-stroke.

In order to combat this phenomenon, a bottom up method (sensorimotor action on the deficit) of constraint-induced movement therapy (CIMT) has been developed and consists in immobilizing the unaffected arm to force the use of the AA.

This technique has proved its effectiveness in the chronic phase and has also recently been proven to improve motor performance in the acute phase. Transposing progress on ADL, however, remains difficult because CIMT does not contain adequate behavioral strategies.

To help the patient mobilize these strategies, coupling of CIMT with a top-down method (conscious action on motor skills) has been successfully tested as an intervention of an occupational therapist with the patient at least 1h / day. This intervention remains not compatible with the investigators care organization because the caregiver can not spend that amount of time with each patient.

Investigators therefore propose to associate CIMT with another top down technique: visual-spatial cueing (use of panels and/or visual messages to encourage the conscious use of the AA) and investigators want to evaluate the effectiveness of this treatment on learning transfer to ADL.

The objective of our study will be to test the feasibility of setting up such an intervention.

Eligibility criteria: Inclusion Criteria:

* Hospitalized patient in neurovascular unit for stroke
* Time since stroke between 2 and 4 days
* Movement capacity of the upper arm (against gravity) :
* Ability to extend actively the metacarpophalangeal and interphalangeal joints at least 10°, and the wrist 20°
* Ability to bend actively the elbow at least 45°
* Ability to bend and abduct actively the shoulder at least ≥ 45°
* Age ≥ 18 years old
* Patient agreement to join the study
* Patient covered by french social security

Exclusion Criteria:

* Excessive spasticity : score \> 2 on the modified Ashworth scale
* Excessive pain in the affected arm : score ≥ 4 on the visual analogue scale
* Joint limitation on the affected arm
* Patient under guardianship or curatorship
* Pregnant or breastfeeding woman

Primary outcomes:
measure: Number of tasks realized per protocol between the two arms
timeFrame: Day 15
Secondary outcomes:
measure: Arm motor function
timeFrame: Day 0, Day 15 and Month 3
measure: Pain evolution
timeFrame: Day 0, Day 7, Day 15 and Month 3
measure: Anxiety and Depression evolution
timeFrame: Day 0, Day 7, Day 15 and Month 3
measure: Situation of patient after neurovascular unit
timeFrame: Month 3
Other outcomes:
Locations:
city: Nantes
country: France
facility: Service de Neurologie, CHU Nantes
Study officials:
affiliation: Nantes University Hospital
name: Ambre Komonski
role: PRINCIPAL_INVESTIGATOR
References: