Automatic Versus Intentional Movement Exercises to Enhance Arm Functions After Stroke

NCT01565044 | Completed

• 1 other identifier: 2011.675
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Upper-limb Paresis

Keywords

Stroke; hemiplegia; automatic pilot; upper-limb rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Fugl Meyer assessment (upper extremity) of motor recovery following stroke

  immediately following the last day of the intervention (Day 12)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

" AUTO " Group

EXPERIMENTAL

Other: motor training

" CONTROL " Group

SHAM COMPARATOR

Other: motor training

Interventions

motor training OTHER

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.

" AUTO " Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service de Médecine Physique et de Réadaptation et Plateforme 'Mouvement et Handicap', Hôpital Henry Gabrielle, HCL

Saint-Genis-Laval, 69235, France

Location

MeSH Terms

Conditions

Stroke; Paresis; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2012
• First Posted: March 28, 2012
• Study Start: September 27, 2012
• Primary Completion: November 3, 2017
• Study Completion: November 3, 2017
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (1)