Robotic Rehabilitation of the Upper Limb After a Stroke (ROBOASSIST)

Clinique Les Trois Soleils

Status: Terminated

Conditions: Stroke

Treatments: Device: Robot InMotion 2.0; Other: Conventional rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT03584477

2011-A00632-39

Details and patient eligibility

About

Hemiparesis is the most common motor disorder after a stroke. Most patients do not recover functional use of their paretic upper limb.

The use of robotic assistance provides intensive motor training through a large number of repetitive movements, usually oriented and interactive tasks (pointing tasks, tracking paths tasks...). These feature have been demonstrated to be critical to stimulate brain plasticity after a brain damage. The InMotion Arm 2.0 manipulator works with an adaptive algorithm that provide patients with real-time Assistance-as-Needed™ desgned to enhance motor performance.

Hypothesis: In the sub-acute phase of stroke, the structured practice of a large number of repeated movements will increase motor function of the upper limb compared to conventional rehabilitation. Secondly, this practice will be more effective in a free active mode (without assistance) than an active assisted mode (Assistance-as-Needed™).

Expected secondary benefits: Subjective impression of improved use of the upper limb in activities of daily living and reduction of spastic cocontractions affecting the agonist and antagonist muscles during movements of the upper limb.

Objectives: This randomized controlled trial will evaluate the effects of structured repetition programs of arm movements, on the function of the hemiparetic upper limb and motor control, between 4 and 10 weeks after the stroke, using a robotic device with or without assistance in partial substitution of conventional rehabilitation care, compared to a program with conventional care alone.

Enrollment: 54 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years;
• Stroke hemiparesis on unilateral focal lesion dating from 4 to 10 weeks at baseline;
• Active flexion of the paretic shoulder ≥15 °;
• Average score on the modified scale of Frenchay <5;
• Patient having agreed to sign an informed consent.

Exclusion criteria

• Passive extension of the paretic elbow <120 °;
• Passive extension of the paretic wrist <10 °;
• Cognitive dysfunction or progressive intercurrent illness making effective communication or participation in the study impossible;
• Infection, inflammation or complex regional pain syndrome of the paretic upper extremity;
• Injection of botulinum toxin to the upper limb less than 3 months old;
• Patient under safeguard of justice;
• Patient include in an other clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 3 patient groups

Conventional rehabilitation

Active Comparator group

Description:

5 sessions / week of 1 hour of occupational therapy

Treatment:

Other: Conventional rehabilitation

Robotic rehabilitation with assistance

Active Comparator group

Description:

5 sessions / week of 1 hour of rehabilitation of the upper limb with 30 min of conventional rehabilitation and 30 min of robotic rehabilitation with assistance.

Treatment:

Device: Robot InMotion 2.0

Other: Conventional rehabilitation

Non-assistance robotic rehabilitation

Active Comparator group

Description:

5 sessions / week of 1 hour of rehabilitation of the upper limb including 30 min of conventional rehabilitation and 30 min of robotic rehabilitation without assistance.

Treatment:

Device: Robot InMotion 2.0

Other: Conventional rehabilitation