Automatic Versus Intentional Movement Exercises to Enhance Arm Functions After Stroke

Not Applicable

• Conditions: Stroke; Upper-limb Paresis
• Interventions: Other: motor training

• Registration Number: NCT01565044
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-26
• Study First Submitted QC: 2012-03-27
• Study First Posted: 2012-03-28
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-22
• Last Update Posted: 2017-08-23
• Primary Completion: 2018-02
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
" CONTROL " Group	motor training	-
" AUTO " Group	motor training	-

Primary Outcome Measures

Name	Time	Method
Fugl Meyer assessment (upper extremity) of motor recovery following stroke	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

Name	Time	Method
Fugl Meyer assessment (upper extremity) of motor recovery following stroke	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
modified Ashworth scale	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.
Visual Analog Pain Scale	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.
Box and block test	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
Frenchey Arm Test	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.
Motor Activity Log (MAL	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.
Functional independence scale (MIF)	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

Trial Locations

Locations (1)

Service de Médecine Physique et de Réadaptation et Plateforme 'Mouvement et Handicap'; 🇫🇷 Lyon, France