Efficacy and Acceptability of the Luna EMG Rehabilitation Robot on Motor Recovery of the Upper Limb in the Chronic Phase of Stroke, Experimental Study in Single Cases.

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \>= 18 years

• Hemiparesis after a first stroke with more than 1 year time interval

• Functional upper limb: ability to do a pointing task at 90% of the hand-acromion distance (free trunk).

• Spastic hypertonia of the elbow flexors 0-2/4 on the Modified Ashworth scale

• Patient affiliated with social security

• Patient having signed a consent to participate in the research

Locations
Other Locations
France
CHU Brest
RECRUITING
Brest
Contact Information
Primary
Olivier Remy-Neris, PU-PH
olivier.remyneris@chu-brest.fr
+33 2 98 22 31 52
Backup
Gwenaël Cornec, MD
gwenael.cornec@chu-brest.fr
Time Frame
Start Date: 2023-06-12
Estimated Completion Date: 2026-06-12
Participants
Target number of participants: 5
Treatments
Active_comparator: Experimental Scheme : A,B,C
The phase B treatment (1.5 hours a day, 5/7 days of conventional rehabilitation and 30mn a day, 5/7 days of treatment with the robot) is scheduled before phase C (2 hours a day, 5/7 days of conventional rehabilitation). The duration of phase B is randomized between 6 and 11 evaluations (2 to 3.5 weeks).
Active_comparator: Experimental Scheme : A,C,B
The phase C treatment (2 hours a day, 5/7 days of conventional rehabilitation) is scheduled before phase B (1.5 hours a day, 5/7 days of conventional rehabilitation and 30mn a day, 5/7 days of treatment with the robot). The duration of phase C is randomized between 6 and 11 evaluations (2 to 3.5 weeks).
Related Therapeutic Areas
Sponsors
Collaborators: EGZOTech
Leads: University Hospital, Brest

This content was sourced from clinicaltrials.gov