Clinical trial NCT01565044: Automatic Versus Intentional Movement Exercises to Enhance Arm Functions After Stroke
Official title: Automatic Versus Intentional Movement Exercises to Enhance Arm Functions After Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Upper-limb Paresis
Keywords: Stroke
hemiplegia
automatic pilot
upper-limb rehabilitation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2012-03-28
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Fugl Meyer assessment (upper extremity) of motor recovery following stroke
timeFrame: 2 weeks following the last day of the intervention (Day 26)
Secondary outcomes:
measure: Fugl Meyer assessment (upper extremity) of motor recovery following stroke
timeFrame: immediately following the last day of the intervention (Day 12)
measure: modified Ashworth scale
timeFrame: immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26)
measure: Visual Analog Pain Scale
timeFrame: immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26)
measure: Box and block test
timeFrame: immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26)
measure: Frenchey Arm Test
timeFrame: immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26)
measure: Motor Activity Log (MAL
timeFrame: immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26)
measure: Functional independence scale (MIF)
timeFrame: immediately following the last day of the intervention (Day 12) and 2 weeks following the last day of the intervention (Day 26)
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de Médecine Physique et de Réadaptation et Plateforme 'Mouvement et Handicap'
Study officials:
References: