Recent work on large cohorts of chronic stroke (\>6 months post-stroke) have shown that intensive training of the upper limb in the chronic stroke patients can lead to substantial motor and functional gains that are maintained at 6 months post intervention. A very prolonged (12 weeks) and very intensive (5 hours daily) training applied to chronic patients after stroke brings a substantial gain both motor and functional which is maintained at 3 months post intervention. Robotic rehabilitation have been shown to be as effective as any other treatment used in rehabilitation. But the methods of implementation remain widely debated. At that time, most robotic therapies have tried to reproduce functional movement mainly pointing objects. We want to demonstrate that analytic movements of the elbow and the shoulder performed with the Luna-EMG robot can replace part of usual physiotherapy treatment with at least the same effectiveness on the recovery of fluid movements of the upper limb after a stroke.
This is a pilot study following a single case experimental design with multiple baselines across subjects (MBD). People included in the protocol will benefit from 2 hours of daily treatment during 6 to 7.5 weeks. The first 2 weeks will be dedicated to baseline measurement of their upper limb (UL) status with daily treatment for balance and gait control without any treatment of the upper limb. The rest of the time will be dedicated to upper limb treatment exclusively. It will be divided into 2 UL training periods, one of them including a 30mn treatment with the luna EMG robot. The duration of second period will be randomly defined between 2 to 3.5 weeks and the last period will last 2 weeks. The treatment during the first UL treatment period will be randomly allocated to Luna EMG treatment or not. The next period will thus follow the inverse scheme (without if the first contains Luna EMG treatment). The fluidity will be assessed through pointing movements assessed every two days. Evaluation of motor deficiency (Fugl Meyer) and functional status (ARAT score) of the UL will be weekly assessed after the inclusion visit. 3D motion analysis of the UL will also be weekly performed. All patients will benefit from a regular follow-up and from an organized care protocol. The sessions will be intensive, all subjects will be able to benefit from the new treatment (LUNA EMG). We can expect a direct individual benefit from the proposed intensive treatment, at least for precision of UL movements.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
5
During phase B, patients will benefit from functional rehabilitation of their upper limbs and from 30mn of training assisted by the LUMA-EMG robot.
CHU Brest
Brest, France
RECRUITINGFluidity of the upper limb
Repeated evaluation of hand movement by the SPARC index during five pointing tasks at 90% of the length of the upper limb at clavicle height, at comfortable speed.
Time frame: up to 7.5weeks
Pain assessment
Use of Visual Analog Scale (VAS) to evaluate the painful (between 0: no pain to 10: intolerable pain)
Time frame: up to 7.5weeks
Motricity assessment
Use of the Fugl-Meyer index (between 0: no motricity to 66: total member motricity)
Time frame: up to 7.5weeks
Function assessment
ARAT (Action Research Arm Test) measurement to assess specific changes in limb function (from 0 to 57, a low score indicating that the movements cannot be performed, and a high score indicating normal performance)
Time frame: up to 7.5weeks
Duration of movement
Kinematic parameter measured 3 times per week
Time frame: up to 7.5weeks
Straightness of movement
Kinematic parameter measured 3 times per week : the trajectory of the hand during pointing movement at a distance normalised by the length of the upper limb will be assessed in motion capture (12 VICONR cameras). The smoothness of the trajectory will be measured by the SPARC (spectral arc length measure) during forward and backward movement.
Time frame: up to 7.5weeks
Average speed of movement
Kinematic parameter measured 3 times per week : the trajectory of the hand during pointing movement at a distance normalised by the length of the upper limb will be assessed in motion capture (12 VICONR cameras). The spatiotemporal parameters (time, distance, average speed) will be measured between the starting position (in front of the trunc) and the final pointed object during forward and backward movement.
Time frame: up to 7.5weeks
Acceptability of the use of the robot
Score between 0 to 100 (a low score indicate that the robot is not well accepted, and a high score indicate a well acceptability)
Time frame: up to 7.5weeks
Satisfaction of the use of the robot
Score between 0 to 100 (0: not satisfied, 100: very satisfied)
Time frame: up to 7.5weeks
Spasticity
Ashworth scale measured 3 times a week and Nottingham scale measured 1 time at inclusion)
Time frame: up to 7.5weeks
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