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

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.

Study Overview

• Status: Unknown
• Conditions: Stroke; Upper-limb Paresis
• Intervention / Treatment: Other: motor training; Other: motor training

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France
    • Recruiting
    • Service de Médecine Physique et de Réadaptation et Plateforme 'Mouvement et Handicap'
    • Principal Investigator: Jacques LUAUTÉ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.; 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.
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	2 weeks following the last day of the intervention (Day 26)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	immediately following the last day of the intervention (Day 12)
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.	immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26)
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.	immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26)
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	immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26)
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.	immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26)
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.	immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26)
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	immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Anticipated): February 1, 2018
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: March 26, 2012
• First Submitted That Met QC Criteria: March 27, 2012
• First Posted (Estimate): March 28, 2012

Study Record Updates

• Last Update Posted (Actual): August 23, 2017
• Last Update Submitted That Met QC Criteria: August 22, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Stroke; hemiplegia; automatic pilot; upper-limb rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Paresis
• Other Study ID Numbers: 2011.675