Back to resultsAutomatic Versus Intentional Movement Exercises to Enhance Arm Functions After Stroke (AUTOTAB)
Primary Purpose
Stroke, Upper-limb Paresis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
motor training
motor training
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, hemiplegia, automatic pilot, upper-limb rehabilitation
Eligibility Criteria
Inclusion Criteria:
- All subjects must be between the ages of 18-80 and must not be pregnant
- Patients volunteer to participate in the study, with a written informed consent signed
- Affiliation to a national health insurance program
- Hemiplegia after stroke
- Stroke onset >6 weeks and <4 years prior to study enrollment
- Patients able to perform the exercises on the automated table
Exclusion Criteria:
- Pregnancy
- Excessive pain in any joint of the paretic extremity (VAS>5)
- Coexistent major neurological or psychiatric disease as to decrease number of confounders
- Subjects with global aphasia and deficits of comprehension
- Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing
Sites / Locations
- Service de Médecine Physique et de Réadaptation et Plateforme 'Mouvement et Handicap'Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
" AUTO " Group
" CONTROL " Group
Arm Description
Outcomes
Primary Outcome Measures
Fugl Meyer assessment (upper extremity) of motor recovery following stroke
we are looking for a change in scores between the baseline session score (Day 1), and those collected during this follow-up session (Day 26).
Secondary Outcome Measures
Fugl Meyer assessment (upper extremity) of motor recovery following stroke
we are looking for a change in scores between the baseline session score (Day 1), and those collected during each follow-up session
modified Ashworth scale
we are looking for a change in scores between the baseline session score (Day 1), and those collected during each follow-up session.
Visual Analog Pain Scale
we are looking for a change in scores between the baseline session score (Day 1), and those collected during each follow-up session.
Box and block test
we are looking for a change in scores between the baseline session score (Day 1), and those collected during each follow-up session
Frenchey Arm Test
we are looking for a change in scores between the baseline session score (Day 1), and those collected during each follow-up session.
Motor Activity Log (MAL
we are looking for a change in scores between the baseline session score (Day 1), and those collected during each follow-up session.
Functional independence scale (MIF)
we are looking for a change in scores between the baseline session score (Day 1), and those collected during each follow-up session
Full Information
NCT ID
NCT01565044
First Posted
March 26, 2012
Last Updated
August 22, 2017
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT01565044
Brief Title
Automatic Versus Intentional Movement Exercises to Enhance Arm Functions After Stroke
Acronym
AUTOTAB
Official Title
Automatic Versus Intentional Movement Exercises to Enhance Arm Functions After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
April 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Many patients retain upper-limb motor impairment following stroke. Most conventional rehabilitation techniques are aimed to improve motor intentional movement by repeated exercises. These techniques require attentional load and are responsible for significant fatigue that probably represents a limiting factor. Alternatively, the automatic control of action is now well documented. A rehabilitation method based on this principle could allow recovery of more natural movements.
Hypothesis: Stimulating automatic motricity improves upper-limb motor skills compared with a rehabilitation technique based on intentional movements.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Upper-limb Paresis
Keywords
Stroke, hemiplegia, automatic pilot, upper-limb rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
" AUTO " Group
Arm Type
Experimental
Arm Title
" CONTROL " Group
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
motor training
Intervention Description
Subject will perform prehension exercises on an automated table. After the initiation of the arm movement, the target to be grasped is programmed to move in order to stimulate automatic motricity.
Intervention Type
Other
Intervention Name(s)
motor training
Intervention Description
Subject will perform prehension exercises on an automated table. After the initiation of the arm movement, the target to be grasped will remain static in order to involve intentional motricity.
Primary Outcome Measure Information:
Title
Fugl Meyer assessment (upper extremity) of motor recovery following stroke
Description
we are looking for a change in scores between the baseline session score (Day 1), and those collected during this follow-up session (Day 26).
Time Frame
2 weeks following the last day of the intervention (Day 26)
Secondary Outcome Measure Information:
Title
Fugl Meyer assessment (upper extremity) of motor recovery following stroke
Description
we are looking for a change in scores between the baseline session score (Day 1), and those collected during each follow-up session
Time Frame
immediately following the last day of the intervention (Day 12)
Title
modified Ashworth scale
Description
we are looking for a change in scores between the baseline session score (Day 1), and those collected during each follow-up session.
Time Frame
immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26)
Title
Visual Analog Pain Scale
Description
we are looking for a change in scores between the baseline session score (Day 1), and those collected during each follow-up session.
Time Frame
immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26)
Title
Box and block test
Description
we are looking for a change in scores between the baseline session score (Day 1), and those collected during each follow-up session
Time Frame
immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26)
Title
Frenchey Arm Test
Description
we are looking for a change in scores between the baseline session score (Day 1), and those collected during each follow-up session.
Time Frame
immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26)
Title
Motor Activity Log (MAL
Description
we are looking for a change in scores between the baseline session score (Day 1), and those collected during each follow-up session.
Time Frame
immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26)
Title
Functional independence scale (MIF)
Description
we are looking for a change in scores between the baseline session score (Day 1), and those collected during each follow-up session
Time Frame
immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All subjects must be between the ages of 18-80 and must not be pregnant
Patients volunteer to participate in the study, with a written informed consent signed
Affiliation to a national health insurance program
Hemiplegia after stroke
Stroke onset >6 weeks and <4 years prior to study enrollment
Patients able to perform the exercises on the automated table
Exclusion Criteria:
Pregnancy
Excessive pain in any joint of the paretic extremity (VAS>5)
Coexistent major neurological or psychiatric disease as to decrease number of confounders
Subjects with global aphasia and deficits of comprehension
Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LUAUTE Jacques, Pr
Phone
4 78 86 50 23
Ext
+33
Email
jacques.luaute@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
VILLENEUVE Laurent
Phone
4 78 86 45 36
Ext
+33
Email
laurent.villeneuve@chu-lyon.fr
Facility Information:
Facility Name
Service de Médecine Physique et de Réadaptation et Plateforme 'Mouvement et Handicap'
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques LUAUTE
12. IPD Sharing Statement
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Automatic Versus Intentional Movement Exercises to Enhance Arm Functions After Stroke
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