Automatic Versus Intentional Movement Exercises to Enhance Arm Functions After Stroke

Stroke Clinical Trial

— AUTOTAB  

Official title:

Automatic Versus Intentional Movement Exercises to Enhance Arm Functions After Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01565044
• Other study ID #: 2011.675
• Status: Recruiting
• Phase: N/A
• First received: March 26, 2012
• Last updated: August 22, 2017
• Start date: March 2012
• Est. completion date: April 2018

Study information

• Verified date: August 2017
• Source: Hospices Civils de Lyon
• Contact: LUAUTE Jacques, Pr
• Phone: 4 78 86 50 23
• Email: jacques.luaute[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: April 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Paresis
• Stroke
• Upper-limb Paresis

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Service de Médecine Physique et de Réadaptation et Plateforme 'Mouvement et Handicap'	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)