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
  Purpose

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 Intervention Phase
Stroke
Upper-limb Paresis
Other: motor training
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Automatic Versus Intentional Movement Exercises to Enhance Arm Functions After Stroke

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 32
Study Start Date: March 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01565044     History of Changes
Other Study ID Numbers: 2011.675
Study First Received: March 26, 2012
Last Updated: April 30, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on August 27, 2014