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The study was stopped because inclusion rate was not met. No inclusion in the last 11 months.
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| Name | Class |
|---|---|
| Assistance Publique - Hôpitaux de Paris | OTHER |
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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-Neededâ„¢ 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-Neededâ„¢).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional rehabilitation | Active Comparator | 5 sessions / week of 1 hour of occupational therapy |
|
| Robotic rehabilitation with assistance | Active Comparator | 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. |
|
| Non-assistance robotic rehabilitation | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot InMotion 2.0 | Device | Repetitive work of large numbers of targeted alternative movements with or without assistance. The passage between with and without assistance taking place according to the evolution of performance judged by the investigator therapist. Note that the duration of the training using the assisted mode should be at least 3 weeks, i.e. half of the total duration of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional performance score change on Modified Frenchay Scale | The scale measures active upper limb function in hemiparesis based on 10 everyday living tasks, each rated on a 10-point visual analogic scale. Six tasks are bimanual and four are unimanual performed with the paretic hand. Final score is an average of the 10 subscores (10 is the higher score). | Between the pre-rehabilitation state on the day of program start (Day1) and the state at the end of the program (Week6) |
| Measure | Description | Time Frame |
|---|---|---|
| Functional performance score change on Modified Frenchay Scale | The scale measures active upper limb function in hemiparesis based on 10 everyday living tasks, each rated on a 10-point visual analogic scale. Six tasks are bimanual and four are unimanual performed with the paretic hand. Final score is an average of the 10 subscores (10 is the higher score). | between Day1 (day of program start) and Week22 (16 weeks after the end of the program) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in perceived function score on the Disability Assessment Scale (DAS) | The scale evaluates upper limb functional disability in patients with spasticity following stroke. Patients are interviewed to determine the extent of functional impairment for the following 4 areas: hygiene,dressing, limb position, pain.The DAS Scale uses a 4-point rating scale according to the following criteria: 0(no disability),1 (mild disability), 2 (moderate disability) and 3(severe disability). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christophe Duret, MD | Clinique Les Trois Soleils | Principal Investigator |
| Jean-Michel Gracies, Pr | Hôpitaux Universitaires Henri Mondor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Les Trois Soleils | Boissise-le-Roi | 77310 | France | |||
| Hôpitaux Universitaires Henri Mondor |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Conventional rehabilitation | Other | Conventional rehabilitation implemented by an occupational therapist, involving stretching movements in submaximal passive amplitude, inhibition postures (Bobath), active efforts assisted of varied difficulty, exercises of direction of the arm towards a target with or without elbow support and grasping tasks, adapted to the capacities of the paretic upper limb. |
|
| Change of motor performance score on the Fugl-Meyer score | Fugl-Meyer (FM) assessment for measures of the motor impairment of the upper-limb; the test includes items related to movements of the shoulder, elbow, forearm (proximal arm), and wrist and hand (distal arm). The total scores range between 0 and 66. | between Day1(day of program start), Week6(end of the program) and Week22 (16 weeks after the end of the program) |
| between Day1(day of program start), Week6(end of the program) and Week22 (16 weeks after the end of the program) |
| Change in perceived function score on the Global Subjective Self Assessment (GSSA) | Three questions were asked to the patient, relating to pain, stiffness-induced discomfort and active function. Each rating was registered by the patient using a visual analogue scale ranging from 0 (worst pain imaginable, worst discomfort imaginable, arm totally useless, respectively) to 10 (no pain, no stiffness-induced discomfort, normal function, respectively). | between Day1(day of program start), Week6(end of the program) and Week22 (16 weeks after the end of the program) |
| Angle and grade of spasticity of the shoulder extensors, flexors and elbow pronators, clinically measured by the Tardieu modified scale | The scale is a clinical measure of muscle spasticity for use with patients with neurological conditions. Spasticity is quantified by assessing the muscle's response to stretch applied at given velocities. | at Day1(day of program start), Week6(end of the program) and Week22 (16 weeks after the end of the program) |
| Paresis angle of shoulder flexion, extension and supination of the elbow; | Paresis angle of shoulder flexion (maximal passive amplitude - maximal active amplitude) | at Day1(day of program start), Week6(end of the program) and Week22 (16 weeks after the end of the program) |
| Kinematic data of the movements based on the robot's records | at Day1(day of program start), Week6(end of the program) and Week22 (16 weeks after the end of the program) |
| Maximum motor force measured by the robot of the abductor/adductor and flexors/extensors of the shoulder | at Day1(day of program start), Week6(end of the program) and Week22 (16 weeks after the end of the program) |
| Créteil |
| 94010 |
| France |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |