Clinical trial NCT03584477: Robotic Rehabilitation of the Upper Limb After a Stroke
Official title: Rehabilitation Program With Robotic Assistance for the Improvement of Motor Performance and Functional Use of the Upper Limb in Subacute Hemiparetic. Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Robot,
Rehabilitation
Hemiparesis
Upper limb
Function
Motor control
Lead sponsor: Clinique Les Trois Soleils
Sponsor class: OTHER
Collaborators: name: Assistance Publique - Hôpitaux de Paris
First posted: 2018-07-12
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Functional performance score change on Modified Frenchay Scale
timeFrame: Between the pre-rehabilitation state on the day of program start (Day1) and the state at the end of the program (Week6)
Secondary outcomes:
measure: Functional performance score change on Modified Frenchay Scale
timeFrame: between Day1 (day of program start) and Week22 (16 weeks after the end of the program)
measure: Change of motor performance score on the Fugl-Meyer score
timeFrame: between Day1(day of program start), Week6(end of the program) and Week22 (16 weeks after the end of the program)
Other outcomes:
measure: Change in perceived function score on the Disability Assessment Scale (DAS)
timeFrame: between Day1(day of program start), Week6(end of the program) and Week22 (16 weeks after the end of the program)
measure: Change in perceived function score on the Global Subjective Self Assessment (GSSA)
timeFrame: between Day1(day of program start), Week6(end of the program) and Week22 (16 weeks after the end of the program)
measure: Angle and grade of spasticity of the shoulder extensors, flexors and elbow pronators, clinically measured by the Tardieu modified scale
timeFrame: at Day1(day of program start), Week6(end of the program) and Week22 (16 weeks after the end of the program)
measure: Paresis angle of shoulder flexion, extension and supination of the elbow;
timeFrame: at Day1(day of program start), Week6(end of the program) and Week22 (16 weeks after the end of the program)
measure: Kinematic data of the movements based on the robot's records
timeFrame: at Day1(day of program start), Week6(end of the program) and Week22 (16 weeks after the end of the program)
measure: Maximum motor force measured by the robot of the abductor/adductor and flexors/extensors of the shoulder
timeFrame: at Day1(day of program start), Week6(end of the program) and Week22 (16 weeks after the end of the program)
Locations:
city: Boissise-le-Roi
country: France
facility: Clinique Les Trois Soleils
city: Créteil
country: France
facility: Hôpitaux Universitaires Henri Mondor
Study officials:
affiliation: Clinique Les Trois Soleils
name: Christophe Duret, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpitaux Universitaires Henri Mondor
name: Jean-Michel Gracies, Pr
role: PRINCIPAL_INVESTIGATOR
References: