Automatic Versus Intentional Movement Exercises to Enhance Arm Functions After Stroke (AUTOTAB)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01565044
First received: March 26, 2012
Last updated: April 30, 2014
Last verified: April 2014

March 26, 2012
April 30, 2014
March 2012
February 2016   (final data collection date for primary outcome measure)
Fugl Meyer assessment (upper extremity) of motor recovery following stroke [ Time Frame: 2 weeks following the last day of the intervention (Day 26) ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01565044 on ClinicalTrials.gov Archive Site
  • Fugl Meyer assessment (upper extremity) of motor recovery following stroke [ Time Frame: immediately following the last day of the intervention (Day 12) ] [ Designated as safety issue: No ]
    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 [ Time Frame: immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26) ] [ Designated as safety issue: No ]
    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 [ Time Frame: immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26) ] [ Designated as safety issue: No ]
    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 [ Time Frame: immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26) ] [ Designated as safety issue: No ]
    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 [ Time Frame: immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26) ] [ Designated as safety issue: No ]
    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 [ Time Frame: immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26) ] [ Designated as safety issue: No ]
    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) [ Time Frame: immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26) ] [ Designated as safety issue: No ]
    we are looking for a change in scores between the baseline session score (Day 1), and those collected during each follow-up session
Same as current
Not Provided
Not Provided
 
Automatic Versus Intentional Movement Exercises to Enhance Arm Functions After Stroke
Automatic Versus Intentional Movement Exercises to Enhance Arm Functions After Stroke

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Stroke
  • Upper-limb Paresis
  • Other: motor training
    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.
  • Other: motor training
    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.
  • Experimental: " AUTO " Group
    Intervention: Other: motor training
  • Sham Comparator: " CONTROL " Group
    Intervention: Other: motor training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
32
April 2016
February 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: LUAUTE Jacques, Pr 4 78 86 50 23 ext +33 jacques.luaute@chu-lyon.fr
Contact: VILLENEUVE Laurent 4 78 86 45 36 ext +33 laurent.villeneuve@chu-lyon.fr
France
 
NCT01565044
2011.675
No
Hospices Civils de Lyon
Hospices Civils de Lyon
Not Provided
Not Provided
Hospices Civils de Lyon
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP