Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-02-20 @ 6:36 PM
Study NCT ID:
NCT03754166
Status:
TERMINATED
Last Update Posted:
2020-12-16
First Post:
2018-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Constraint-induced Therapy Combined With Visual-spatial Cueing Strategy in Patients With Acute Stroke
Sponsor:
Nantes University Hospital
Organization:
Study Overview
Official Title:
Feasibility of Modified Constraint-induced Movement Therapy Combined With Visual-spatial Cueing Strategy in Patients With Acute Stroke
Status:
TERMINATED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study non feasible following changes in organisation of service
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ITHEMICAL
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: