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

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ClinicalTrials.gov Identifier: NCT01565044
Recruitment Status : Recruiting
First Posted : March 28, 2012
Last Update Posted : August 23, 2017
Sponsor:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment
Stroke Upper-limb Paresis Other: motor training

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Automatic Versus Intentional Movement Exercises to Enhance Arm Functions After Stroke
Study Start Date : March 2012
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: " AUTO " Group 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.
Sham Comparator: " CONTROL " Group 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.


Outcome Measures

Primary Outcome Measures :
  1. Fugl Meyer assessment (upper extremity) of motor recovery following stroke [ Time Frame: 2 weeks following the last day of the intervention (Day 26) ]
    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 :
  1. Fugl Meyer assessment (upper extremity) of motor recovery following stroke [ Time Frame: immediately following the last day of the intervention (Day 12) ]
    we are looking for a change in scores between the baseline session score (Day 1), and those collected during each follow-up session

  2. 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) ]
    we are looking for a change in scores between the baseline session score (Day 1), and those collected during each follow-up session.

  3. 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) ]
    we are looking for a change in scores between the baseline session score (Day 1), and those collected during each follow-up session.

  4. 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) ]
    we are looking for a change in scores between the baseline session score (Day 1), and those collected during each follow-up session

  5. 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) ]
    we are looking for a change in scores between the baseline session score (Day 1), and those collected during each follow-up session.

  6. 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) ]
    we are looking for a change in scores between the baseline session score (Day 1), and those collected during each follow-up session.

  7. 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) ]
    we are looking for a change in scores between the baseline session score (Day 1), and those collected during each follow-up session


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01565044


Contacts
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

Locations
France
Service de Médecine Physique et de Réadaptation et Plateforme 'Mouvement et Handicap' Recruiting
Lyon, France
Principal Investigator: Jacques LUAUTE         
Sponsors and Collaborators
Hospices Civils de Lyon
More Information

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01565044     History of Changes
Other Study ID Numbers: 2011.675
First Posted: March 28, 2012    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017

Keywords provided by Hospices Civils de Lyon:
Stroke
hemiplegia
automatic pilot
upper-limb rehabilitation

Additional relevant MeSH terms:
Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms